FROM
MOLECULETO MEDICINEONE INTEGRATED PARTNER
FOR EVERY STEP OF YOURDRUG DEVELOPMENT JOURNEYMike Pearson
Staff Program Manager,
Pharma Services
Bend, OR

HOW LEVERAGING A GLOBAL NETWORK DELIVEREDBIG RESULTS.
Mike’s team in Bend, OR was only supposed to optimize the spray drying process for a particular medication while another,much larger, facility would handle the large-scale manufacturing. However, the other facility’s equipment wouldn’t be available
in time to meet the client’s aggressive IND filing schedule. It was time to leverage the power of the Thermo Fisher Scientificglobal network and Quick to Care™ program to offer the client their best chance for success. Through incredible effort andintensely coordinated activities, the team in Bend delivered nearly two orders of magnitude more material than typical projects
before transferring the product to other Thermo Fisher sites to test, fill, and deliver to patients. Despite the change in plans, theright team stepped in to ensure all deadlines were met, and the client got a critical medicine to the patients who needed it most.

2

Welcome to Thermo Fisher Scientific, your integrated drug development partner
who never loses sight of our shared goal — improving patients’ lives.
Our Thermo Fisher Scientific Pharma Services business was created by combining the CDMO capabilities of Patheon and theclinical trial capabilities of Fisher Clinical ServicesSM. With other recent acquisitions and continued expansions to provide endto-end solutions, we have simplified our branding by aligning all CDMO and clinical service offerings under the Patheon brand.
We are an integrated force and stronger than ever. Built on a proven foundation of quality systems and commitment to continuous improvement, we have the capabilities and expertise to help you achieve success in drug development.
Everything we do is focused on making certain that your molecule can become what it was meant to be—a discovery thatcan change patients’ lives for the better and make the world healthier, cleaner and safer. All of us—from our scientists andengineers to our line operators and business professionals—take our work personally. We are firm in our belief that all
people deserve a healthier life. That’s why our trusted team, built on experience, insight, and the passion to deliver the best
possible outcomes, apply heart and science in all they do.
In the pages ahead, find out how we can solve your most complex drug development and manufacturing challenges.

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TABLE OF CONTENTS
03

Introduction
Welcome to Thermo Fisher Scientific, your truly integrated pharma services partner.

06

Small molecule drug substance capabilities
Learn how our proven API capabilities can solve your most complex challenges.

10Large molecule drug substance capabilities
Reduce your risk, not your return. Now that’s biological.

16

Advanced cell and gene therapy solutions
Innovative services, from process development to commercial supply.

20

Early and late phase development capabilities
Surround your discovery with science, speed and service.

26

Quick to Care™ integrated offering
Integrated drug development and clinical services for new and emerging pharma.

28

Clinical trial solutions
Global clinical supply solutions for every trial.

32

Logistics services
Proven solutions to tackle your toughest challenges.

36

Commercial manufacturing
Where innovative thinking meets a trusted partnership.

46

Softgels technologies for Rx and OTC
Discover softgel innovation and unique OTC solutions.

50

Global site network
Unmatched, fully integrated global site network.

4

Emily Anderson, PhD
Analytical R&D,
Pharma Services
Florence, SC
Jessica Floyd
QC Lab Supervisor,
Pharma Services
Florence, SC

HOW, IN A CULTURE OF KNOWLEDGE SHARING, A
MENTOR PAVED THE WAY TO SUCCESS FOR THEIRMENTEE.
At Thermo Fisher Scientific, we believe that knowledge belongs to everyone. So, years ago, when Emily worked with her intern,
Jessica, in the analytical department, she taught her all she could, as freely as possible. Today, Jessica leads her own teamin quality control. Because of her past experience, she is uniquely qualified to identify issues that might have otherwise been
missed and everyone benefits. This unique culture of knowledge sharing is a big part of how we get medicine into the handsof patients faster.

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SMALL MOLECULE DRUG
SUBSTANCE CAPABILITIES

Meet the people who make it right the first time from grams to tonnes.
Our people pride themselves on solving your unique challenges. We optimize processes to speed your molecule throughearly phase trials and apply initial learnings to prepare you for commercial success faster. But whether you start with us inearly phase or late, we draw on years of experience and deep expertise to keenly focus on superior delivery performance.
Whether you need grams of API for an in-house project or kilo after kilo for a late phase trial or commercial supply, you canreduce the risk and raise the bar on quality by working with a partner whose reputation stands on both quality and excellencein chemistry. In addition, our high-quality APIs and intermediates are made in the same facilities and to the same stringent
standards. So you can rest assured that your molecule is surrounded by quality and care.

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Get to market fast withintegrated API solutions.

A COMPREHENSIVE RANGE OF CHEMISTRYAND MANUFACTURING TECHNOLOGIES
Providing the right chemistry and technological capabilities
are the basis for today’s API development and manufacturing.
Thermo Fisher offers you cutting-edge technology fromstart to finish in multi-step chemical synthesis, and fromtraditional to complex manufacturing. We’re also ready tohelp determine what is both technically and financially
feasible for your project. Our breadth of capabilities includes:

DISCOVER EXPERTISE AND GLOBALREACH FROM CLINICAL TO COMMERCIAL
API PRODUCTION
Thermo Fisher Scientific gives you a complete range ofsolutions and services at world-leading facilities in Europe
and North America. Start with us early and we’ll help you
scout a manufacturing route forward. Join us in later phases
and get the insight and quality that leads to success faster.
Throughout your journey to market, we offer:࡟ Route scouting࡟ Process development
࡟ Clinical supply manufacturing࡟ Tech transfer and scale-up of new andexisting processes࡟ Continuous improvement of existing processes

Microreactor flow chemistry
Get the efficiency, flexibility and scalability of microreactor
flow chemistry. We run continuous processes on small reactor
scales to deliver improved product quality and higher yields.
The same process is used for early phase batches and latephase/commercial batches, simplifying scale-up.
Today’s advanced catalysis discoveries can require complex,
multi-step chemical synthesis, making it difficult to proveviability quickly. Thermo Fisher makes more of these discoveries feasible with advanced catalysis tech-nologies
that can reduce timelines from years to months. You’ll haveaccess to interdisciplinary route scouting expertise, chemocatalysis and biocatalysis, proprietary bio-catalytic processes,
and experience with large-scale complex processes thatdevelopment-only labs do not offer.

࡟ E xpertise with difficult-to-manufacture APIs࡟ Innovative solutions to manufacture yourcomplex API࡟ High potency compounds and controlled
substances࡟ Comprehensive analytical services

Polymers
With over 20 years of experience, we lead the way in polymeric API technology. This lets you create completely
unique products by combining proprietary process technologies, polymer science, advanced synthesis and large
scale cGMP expertise.

࡟ Commercial supply manufacturing࡟ Supply chain management࡟ Spray drying
࡟ Micronization
࡟ Physical characterization

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PROCESS VALIDATION—ENSURING A RELIABLE
COMMERCIAL SUPPLYIn clinical phases and as part of the establishment of yourcommercial supply of API, we provide a complete validation
package according to regulatory and cGMP guidelines,
including:࡟ Quality by Design (QbD) and Proven Acceptable
Ranges (PAR)࡟ Process validation with critical parameters

CLINICAL AND COMMERCIAL BATCH
MANUFACTURING—QUALITY, SPEED AND SCALE࡟ Validation of analytical assays
࡟ Release testing

Early-stage clinical supplies of API are produced at stateof-the-art cGMP facilities in Europe and North America. A
team of experts will surround your discovery with a fullrange of technologies and analytical services to not only
run the project with the highest degree of flexibility, but alsodeliver on time with exceptional yields and superior quality.

࡟ Stability studies at required ICH conditions

In late-stage trials and beyond, your drug substance will be
manufactured at a cGMP commercial production facility
where a team of experts works continuously to optimize
processes, increase outputs and reduce timelines.

END-TO-END SOLUTIONS FOR THE SMALL
MOLECULE CHALLENGES AHEAD

Our clinical and commercial batch manufacturing capabilities
include:࡟ A comprehensive array of technologies, services
and solutions
࡟ Flexible manufacturing solutions
࡟ Scalable processes࡟ Dedicated teams and multiple facilities for clinicaland commercial scale manufacturing࡟ Total capacity in excess of 800,000 L with reactors
as large as 16,000 L
࡟ Access to a streamlined end-to-end supply chain࡟ Full regulatory support with CMC documentation

࡟ Container shipment studies࡟ CMC documentation in CTD format

In as little as 14 weeks from receiving your API, you can haveyour Phase I product manufactured, labeled, packaged anddelivered to the clinic with Quick to Clinic™ small molecule.
That’s up to 1 month faster than most standard timelines.
We have the science, methods, breadth of services andtechnology to solve the most complex small molecule
challenges. The proven ability to make it Right-The-FirstTime, every time. Scale from grams to kilos to tonnes. A
superior regulatory track record. A faster, seamless pathfrom early API development to scale-up and commercialization. Global reach and scale.
These are just a few of the reasons to choose Thermo Fisher
for your API production. Yet, the most compelling reason is
our people: The scientists, engineers and experts who
surround your discovery with the sharpest minds in thebusiness. So you can maximize the true potential of yourmolecule and deliver it to the patients who need it most.

࡟ Regulatory approvals to work with controlled
substances and highly potent compounds

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Jeff Hou, PhD
Manager, Cell Culture Development,
Pharma Services
Princeton, NJ

HOW A SMALL STARTUP WAS ABLE TO SCALE UP,WITHOUT LOSING THEIR PRECIOUS MATERIAL.
Jeff faced a dilemma: how to complete a large biomanufacturing scale up with the very small amount of material his client
gave him. And the stakes were high. His client had spent a lot of time and money developing this potentially revolutionary
Alzheimer’s treatment. Any wasted material would put the execution of the clinical trial at risk, and possibly risk the future of
the entire program. Jeff knew the process needed to be perfect. So, his team worked tirelessly to find ways to improve thecell culture performance. They examined key process parameters and even completed additional work in the processdevelopment laboratory to ensure success. The result was a flawless scale up and, most importantly, a potentially breakthroughdrug was able to get into the clinic.

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LARGE MOLECULE DRUG
SUBSTANCE CAPABILITIESLet our biologics experts show you how to speed development and unleash thepotential of your discovery.
Your molecule has the power to change lives and shape the future. Thermo Fisher Scientific is the company that offers theflexibility and speed to help you get ahead of schedule while maintaining the highest quality. We bring scientific expertiseto every challenge and our proven track record of scaling up biologics helps ensure you gain cost and time savings at every
stage of the biologic development process.
Just as important, our people understand the long and complex journey ahead, and are as committed to your success as
you are. We are driven by science and have the experience to solve complex large molecule challenges.

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Discover flexible solutions,custom built on comprehensive
capabilities and experience.

UNLOCKING SUCCESS WITHOUTLOCKING YOU IN
We pride ourselves on our ability to create flexible options
for our clients. We understand the uncertainty associatedwith forecasting demand. We think strategically to offer biomanufacturing options that meet the unique needs of yourmolecule, and can work with your cell lines. Our contracts
are individualized to meet your requirements, we do not
require you to use proprietary technology, and we do not
charge royalties. Our strong reputation is built on successfullytransferring complex molecules.

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INTEGRATED
OFFERINGQUICK TO CLINIC™ BIOLOGICS HELPS YOUBALANCE SPEED, RISK, AND FUTURE NEEDSDURING EARLY DEVELOPMENT
The pressure to file an IND makes accelerated Phase I
safety testing a priority. With the Quick to Clinic™ biologics
program, Thermo Fisher Scientific can deliver your large
molecule released drug substance and drug product forFirst-in-Human studies in as little as 13 months. Now you
can meet important mile-stones such as filing the IND,
or securing additional funding, with confidence. Our Quickto Clinic™ program for Biologics is made with speed andflexibility because we understand the importance of
reducing the time it takes to get your discovery to thepatients who need it.

PROCESS DEVELOPMENT CAPABILITIES—FLEXIBILITY, QUALITY AND SERVICE
We apply our process development skills to significantly
increase the batch yield and reduce processing time foryour molecule. Applying Design of Experiment (DoE) methodology to both Upstream and Downstream processing, wedefine the CPPs and CQPs that enable robust processes,
maximize yields, and optimize throughput. For Upstream
processing, we utilize the Sartorius ambr® 15 and 250
platform as well as 0.5 L, 1 L, and 10 L single-use bioreactors
to define optimal feed and processing conditions.

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UPSTREAM PROCESSING CAPABILITIESWith a fully integrated global network of cGMP facilities
across Europe, North America, and Asia-Pacific, we are aleader in manufacturing monoclonal antibodies andrecombinant proteins using single-use technologies. Our
expertise spans multiple commercial cell lines including
CHO. We also specialize in fed-batch and perfusion cell
culture processing.
Fed batch processing
We can achieve stable reliable production at titers >5 g/L.

ANALYTICAL SERVICES THAT MEASURE
WHAT IS MOST IMPORTANT TO YOU
Our analytical capabilities include rapid identification andcharacterization of your recombinant protein or antibody,development and implementation of cGMP methodologies
and data generation for regulatory submissions. Analyticalmethods are developed in process development by thesame teams that will use them in manufacturing, to avoid
delays and errors created by handoffs. Our breadth ofanalytical services and capabilities include:
Analytical methods and method validation

Perfusion processing࡟ Glycan profiling

We can achieve high productivity and manufacture of unstable
proteins.

࡟ ELISA assays for product and impurity
assessments

Single-use technology࡟ Gel and capillary based electrophoresis

We can help you reduce technology transfer and scale-up
risks and eliminate cross-contamination concerns. We offer
multiple single-use bioreactor platforms and scale: 250 L,
500 L, 1000 L, and 2000 L.

࡟ Gel and capillary based isoelectric focusing࡟ Residual DNA detection
࡟ Cell-based bioassays
࡟ Immunologic and colorimetric assays

DOWNSTREAM PROCESSING CAPABILITIES
Thermo Fisher offers a range of purification processes that
ensure your drug substance is of the highest quality andyield, including:࡟ Depth filtration࡟ Tangential and alternating tangential flow filtration࡟ Mass spectrometry࡟ ICH stability testing

PROCESS VALIDATION—ENSURING RELIABILITYOF SUPPLY AND CONSISTENT QUALITY
In late clinical phases, and as part of the establishment of
your commercial supply, Thermo Fisher provides a complete
validation package according to regulatory and cGMP
guidelines. BLA / PPQ-enabling process characterizationand validation activities include:࡟ UF / DF development
࡟ Chromatography development
࡟ Nanofiltration and virus inactivation
࡟ Viral clearance studies

࡟ Process characterization

࡟ Final product formulation

࡟ Validation of process and analytical methods࡟ Robustness studies

࡟ PPQ campaigns࡟ Container shipment studies࡟ CMC documentation in CTD format

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NETWORKTECHNOLOGIES12PERSONAL ATTENTION TO THE DETAILSAt Thermo Fisher Scientific, you’ll be assigned a project
manager who will serve as your main point of contact, as
well as a cross-functional team dedicated to designing aprocess that meets the needs of your discovery and yourbusiness. If you are a consultant, we also understand yourunique role and can offer customized, flexible solutionsaligned to your clients’ needs.

TECH TRANSFER FOR A STRATEGICAND FINANCIAL ADVANTAGE
Technology transfers, either for a scale-up or a move toanother facility, are part of the normal course of business. If
the transfer is urgent, our team has a proven track record ofquick, effective executions to get your project back on track
and preserve product supply. In all cases, we are driven by
your deadlines, flexible in our approach and determined to
get it Right-The-First-Time, every time.

Flexible, end-to-end
solutions for development
and commercial production.
Work with one partner for both drug substance and drug
product manufacturing at the development and commercial
scale. Our knowledge of formulation development and bioprocessing ensures that your molecule is “formulation
ready” regardless of the stage you are at.

CUSTOMIZED BIOMANUFACTURING SOLUTIONS
We offer a range of versatile solutions to overcome capacity
restraints while meeting the highest quality and regulatory
standards.
Global network
Take advantage of our manufacturing locations in North
America, Europe, and Asia-Pacific for simplified logistics
and R&D tax advantages.

FROM TRADITIONAL CAPACITY TO CUSTOMIZABLE MANUFACTURING MODULES.

Dedicated capacity
Allocate capacity foreach of your products
and transfer capacity
in and out of the line.

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SUBSTANCECAPABILITIESFractional
ownership

Flexible
network accessCondominium
capacity

Sharing a line or
facility lowers cost
while allowing you
to achieve flexibility
and scalability.

Get anytime accessto a specific type of
capacity within our
global network.

A fully customized
solution that includes
everything fromdesign services
to operational
management.

ADVANCED
CELL ANDGENE
THERAPY
SOLUTIONSEARLY ANDLATE PHASE
DEVELOPMENTCAPABILITIESQUICK TOCARE TM
INTEGRATED
OFFERING

Enterprise
For clients who
own facilities, weoffer operational
improvements andrepurposing ofexisting equipment.

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A SCIENCE-DRIVEN APPROACH TO REDUCINGRISK AND REALIZING THE REWARDS
We offer a depth and breadth of innovative biologic capabilities from development to commercialization. We pioneer
new technologies to improve the manufacturing process.
Our teams focus precisely on every step, but never forget
the end goal. We think strategically to offer flexible, fast,
efficient approaches to helping your discovery through thecomplex journey to market.

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The scientists, engineers and professionals of Thermo
Fisher Scientific apply a science-driven, risk-based approachto every step of the biologic development and manufacturing
process. They draw on years of experience and partner withyou at the stage of development that is most advantageousfor your business. Because this is the best way to makecertain your discovery lives up to its promise for the patients
who need it most.

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Katie Shannon
Senior Director of Engineering,
Viral Vector Services
Cambridge, MA

HOW VIRAL VECTOR TECHNOLOGY IS RAPIDLY SCALINGUP TO ENABLE ONE MIRACLE AFTER ANOTHER.
The promise of viral vectors has been pursued for over two decades. But in the last few years, this transcendent technology
that’s targeting over 200 diseases has finally started to create real treatments and possible cures. This sudden momentum
has put Katie and her team to the test. With major capital investments, they’ve built out Thermo Fisher’s Viral Vector capacity
in just under 30 months, across three locations. Katie has had to customize these locations to the new and innovativetechnology, and constantly shifting demands. As she says, “we’ve literally had to move walls while we’re in the middle ofbuilding them.” But nothing stops her and her team. Not even 50 tons of boulders discovered beneath a construction site. In
spite of the obstacles, she and her team build for maximum flexibility, even with the demands of the most precise science on
the line. With three viral vector manufacturing sites and more on the horizon, engineers like Katie and her team are paving theway for pharma and biotech companies to bring new treatments to market, and potentially save millions of lives.

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ADVANCED CELL AND GENE
THERAPY SOLUTIONS

Get your advanced therapy to market faster.
Cell and gene therapies are generating positive clinical results at an accelerating rate, with multiple products in late-stage
development and expected to be licensed in the near future. The gene and cell therapy markets are growing rapidly at about
25 percent per year, and the FDA predicts that by 2025, 10 to 20 new gene therapy products will be approved each year.
These novel, life-saving therapies are treating diseases that were, until recently, untreatable.
Advanced therapeutics, including cell and gene therapies, have the potential to completely revolutionize the state of healthcare,and speed is of the essence. A partner that has the expertise, capacity, and global supply network is increasingly critical toseamlessly transition from clinic to commercial with confidence. Thermo Fisher Scientific offers the confidence of partneringwith an experienced CDMO, combining scale with breadth of services and support network to meet your critical timelines.

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Experienced viral vector
services deliver robust
support without long queues.

We have experience working with a broad range of viral
vectors products (AAV, AV, LV, HSV, and RV), serotypes andpseudotypes. We have completed over 130 viral vector
projects completed using a variety of manufacturing technologies in the delivery of over 500 viral vector cGMP clinicaland commercial lots. Our team of innovative employees isfocused on serving the needs of clients and patients.

Viral Vector Services provides process and analyticaldevelopment along with clinical and commercial supply ofviral vectors for in vivo gene therapy and ex vivo gene-modified
cell therapy. With over 20 years of experience, we accelerate
the transition from development laboratory to patients. From
pre-clinical and clinical development, to commercial approval,
our expertise enables us to meet both cGMP standards andindustry expectations with high integrity. We are enabling
biopharma customers to deliver break-through medicines
to patients by unleashing the potential of gene therapy.

The design and recent expansion of our cGMP-compliant,state-of-the-art, multi-product facilities and use of singleuse equipment allows maximum flexibility for manufacturing
platform, scale and project scheduling, while ensuring
product quality. As we strive to exceed expectations, ourcollaborative approach ensures that our clients are involved,
engaged, and well informed throughout the project.

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INTEGRATED
OFFERING

Viral vectors are complex and require deep expertise to analyze
and manufacture. We have long established this capability.
Combined with Thermo Fisher’s GMP production expertise,
we are uniquely positioned to partner with our clients to drive
the evolution of this incredibly fast-growing market.

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VIRAL VECTORDEVELOPMENT & MANUFACTURING࡟ Single cell and virus cloning and screening࡟ cGMP cell and virus banking
࡟ Process development, characterization and qualification
࡟ Analytical method development, qualification and validation

Services࡟ Pre-clinical, clinical and commercial viral vector production
࡟ State-of-the-art clinical and commercial aseptic fill and finish services
࡟ QC release and stability testing࡟ Clinical/commercial state-of-the-art warehouse࡟ regulatory services
PRECLINICAL
200L

Suspension
manufacturing
platforms

CLINICALCOMMERCIAL

4x200 L

4x2000 L

500 L WV

1,000 L200L

2,000 LPRECLINICAL
Flatstock

Adherent
manufacturing
platforms

iCELLis® 500
iCELLis® nano
CLINICALCOMMERCIAL

Flatstock

FlatstockiCELLis® 500

iCELLis® 500

AAV

ADENOVIRAL

Adherent +Suspension

Producer cell line
+ Ad

Suspension +HSVSuspension +Baculovirus

Adherent +Suspension

Mammalian cells
transient transfection

Mammalian cells
infection

Mammalian cells
infection

Insect cells infection

Mammalian cells infection

LENTIVIRALRETROVIRALHERPESVIRAL

Packaging/
Producer cell line

Adherent +Suspension

Packaging/
Producer cell line

Adherent +Suspension

Adherent +Suspension

Mammalian cells

Mammalian cells
transient transfection

Mammalian cells

Mammalian cells
transient transfection

Mammalian cells infection

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AVOID TRANSITIONS IN MATERIAL QUALITY
AND SAVE CRITICAL MANUFACTURING
TIME WITH COMMERCIAL-QUALITY GMP
PLASMID DNA

INTEGRATED SERVICES AND BROADCAPABILITIES TO SUPPORT MRNA
THERAPEUTICS

Plasmid DNA forms the genetic foundation for many
therapeutic strategies, and the growth of cell and genetherapies as well as the rapid emergence of the mRNA
vaccine market has created intense pressure on manufacturing of plasmid DNA. Thermo Fisher Scientific has
responded to the call by expanding capacity and service
offerings so you can get to market faster. Services include:

The emergence of mRNA therapeutics including thedevelopment of new vaccines and gene therapies has createda market constraint on access to critical raw materials andtechnical expertise. Thermo Fisher Scientific knows nucleic
acids and pharmaceutical services and has worked tointegrate our capabilities across the operational value chain
to enable you to move your mRNA therapeutic fromdevelopment to commercialization. Services include:࡟ Process development and optimization

࡟ Process development and optimization

࡟ Master cell banking

࡟ Clinical mRNA scale࡟ Scale up to GMP for clinical and commercial

࡟ Scale up to GMP for clinical and commercial

࡟ Critical raw material or drug substance࡟ Full scale mRNA࡟ In-Process and release testing࡟ Upstream ingredient supply࡟ Stability testing and storage

LEVERAGE EXPERTISE AND FLEXIBILITY TO
ADVANCE CELL THERA-PIES AT A RAPID PACE
Cell and gene therapies have been quickly gaining traction
with many market approvals anticipated yearly. Speed is of
the essence, which is why having a partner who knows
what’s expected in regulated environments, has theflexibility to serve your unique needs, and can assist acrossyour entire value chain is so important. Thermo Fisher
Scientific has the expertise and flexibility you need tocontinue moving at a rapid pace. Services include:࡟ Process and method development andoptimization
࡟ Master cell banking

MAINTAIN SPEED, TEMPERATURE, AND
INTEGRITY FOR ADVANCED THERAPIESACROSS YOUR SUPPLY CHAIN
With experience maintaining the integrity of millions ofsamples in our global network of biorepositories, we are theexperts in transporting, storing, and handling specializedbiological samples and material, from ambient to cryogenic
temperatures. Consistent quality. Global network. Dedicatedto you. Services include:࡟ GMP biologics management – ambient tocryogenic storage globally࡟ Continuous monitoring࡟ Specialty courier services
࡟ Clinical to commercial distribution

࡟ GMP for clinical࡟ Clinical site receipt and administration

࡟ Sterile Fill/Finish of DS࡟ Cryopreservation
࡟ Stability

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Sanjay Konagurthu, PhD
Sr. Director, Science & Innovation,
Pharma Services
Bend, ORHOW TAKING THE EDGE OFF A CRYSTAL GAINED ANADVANTAGE.
Sometimes, even if your job focuses on data, you have to look beyond it. That’s why Sanjay and his team at Thermo Fisher
Scientific don’t just apply data to solve formulation challenges. They look beyond the data for other potential roadblocks. In
the early phase trials of a complex API molecule, his team recognized that dagger shaped crystals were inhibiting flow during
production. While short-term workarounds for trials were at hand, they knew that in future scale ups, this would become asignificant problem. So they collaborated with teams who modified the API process in advance. Smoothed the crystal. And
solved the problem before it became one.

20

EARLY AND LATE PHASE
DEVELOPMENT CAPABILITIESOur experts anticipate problems before they even start, improving your chancesof success at every stage of drug development.
Your discovery has the potential to shape the world. Thermo Fisher Scientific has the proven experience, scientific expertiseand problem solving skills to make certain your molecule—small or large—lives up to its greatest potential. We work withyou to meet the requirements of every step and phase faster, more efficiently and cost effectively. And our proven trackrecord scaling from one development phase to the next helps ensure the therapies we make together have the best chance
to reach the patients who need them most.

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INTEGRATED
OFFERING

CLINICAL TRIAL LOGISTICS COMMERCIALOTC AND
GLOBAL SITE
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THE RIGHT ROUTE FOR COMPANIESOF EVERY SIZEAt Thermo Fisher Scientific, your molecule comes first.
Whether your company is emerging or a giant in the industry,
our people are dedicated to identifying the best pathforward for your molecule. They are ready to guide you
through our flexible, agile and scientifically driven
development services from the very early stages ofdevelopment through late stage trials and beyond. What’smore, working with us from the beginning lets you use early
development insights to cut time and costs in later
development stages.

CHOOSE FROM A BROAD RANGE OF ORAL
SOLID AND STERILE DOSE FORMS TO MEETYOUR UNIQUE NEEDS
Flexibility, speed, expertise, and experience are needed toadvance your oral solid and sterile injectable drug products
from the preclinical phase to approval. Let us help you
transform your discovery into a drug product with the best
chance for approval by leveraging:࡟ Flexible approaches to maximize speed
and minimize cost

The people and thecapabilities to meet yourtoughest development
challenges.

࡟ Formulation and process development
࡟ Optimization for cost and quality
࡟ Proven technology transfer experience࡟ Scalability to commercial manufacturing
࡟ Strong regulatory track record

Every step of the development process brings unique challenges and opportunities. Time, cost, and results are critical.
But sacrificing quality is never an option. As a result, we havedesigned a range of flexible solutions to meet your molecule’s
unique needs across formulation development, analyticalmethod development, solubility enhancement, manufacturing
process development and clinical batch manufacturing.
As important, all our professionals—scientists, engineers,
project managers and operators—are committed to a cultureof problem solving. Bringing deep scientific insight, realworld development experience and always a “safe pair ofhands” to your project. No one has touched more molecules
than we have.

With extensive experience, we understand the unique challengesof developing oral solids and sterile injectables. We offer abroad range of capabilities to address the specific needs ofyour drug product including:
Sterile dose forms
࡟ Small and large volume parenterals
࡟ Liquid filled vials
࡟ Lyophilized vials
࡟ E xtensive range of vial sizes including
ISO standard࡟ Pre-filled syringes and cartridges
Oral solid dose forms࡟ Tablets
࡟ Capsules
࡟ Layered technologies
࡟ Beads/microtablets
࡟ Modified release profiles

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SOLVING SOLUBILITY ISSUES BEFORE THEY
BECOME PROBLEMS

PRE-FORMULATION AND ANALYTICALCAPABILITIES AT A GLANCE

An estimated 70-90% of molecules experience solubility
challenges. If not solved early, these issues can derail earlyphase trials, and lead to higher costs and missed deadlines
in later stages. As a result, Thermo Fisher offers broad
tech-nological capabilities, including:We give you access to a broad, proven range of formulation
and analytical capabilities to take your molecule from Preclinical to Phase I clinical studies and beyond. Each of ourdevelopment and manufacturing sites have cGMP labs
staffed by highly experienced scientific teams.

࡟ Spray drying

Pre-formulation capabilities

࡟ Lipid formulations

࡟ Chemical purity analysis

࡟ Hot-melt extrusion

࡟ Physicochemical properties

࡟ Coated beads

࡟ Solid form definition and analysis

࡟ Size reduction (e.g. micronization)

࡟ Excipient compatibility testing࡟ Cyclodextrin complexes

࡟ Amorphous vs. crystalline solid-state testing

A BREAKTHROUGH IN TAKING THE
GUESSWORK AND TIME OUT OF FORMULATION
It’s called Patheon™ Quadrant 2™ and it is a one-of-kind,computational modeling tool. Designed exclusively for
Thermo Fisher clients, this innovative program rapidly
accelerates early formulation development and cuts thecosts of trial and error experimentation.
Quadrant 2™ analyzes the molecular structure, and physicaland chemical characteristics of a compound, and predicts
the solubility enhancement technology and excipient
combination that are most likely to succeed based on:࡟ Aqueous and solvent solubility
࡟ Solution and solid-state stability
࡟ Vehicle screening for ADME and toxicology
Analytical capabilities
࡟ Physical and chemical definition analysis
࡟ Method development and validation
࡟ Impurity tracking
࡟ In-process production support
࡟ Stability testing for various ICH climatic zones
࡟ Genotox studies
࡟ PAR studies

࡟ API chemical structure
࡟ Physicochemical properties࡟ Full-scale molecular modelling based on Quantumand Molecular Dynamic simulations

QUICK-TO-CLINIC™ ACCELERATES THE TIME
TO PHASE I CLINICAL TRIALS࡟ E xclusive excipient descriptor database developedby Thermo Fisher

In as few as 14 weeks, the Quick to Clinic™ small moleculedelivers high-quality Phase I material and the data you needto support your Phase I clinical trials. This program delivers:

The proposed solubility enhancement technology and excipient
combination are confirmed via a cross verification/model validation approach with more than 200 commercially available
molecules, and has proven to be over 90% accurate for technology selection and over 80% accurate for excipient selection.

࡟ Phase appropriate analytical method development
and validation
࡟ Phase appropriate simplest of dosage forms(API in a capsule, tablet or bottle)
࡟ Bulk packaging or simple in-house HDPE bottles
࡟ One-month stability testing࡟ Product development summary report

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Thermo Fisher
injectables is theleader in both NME& NDA approvals
Demonstrated trackrecord with the
FDA in securing
approvals of novel
drugs for clients

CMO market share of parenteral
NME approvals, 2011-2020

CMO market share of parenteral non-NME
NDA approvals, 2011-2020
Thermo Fisher Scientific Inc
98%

Thermo Fisher Scientific Inc
24
15%

Emergent
BioSolutions Inc
6
5%

Vetter PharmaFertigung GmbH &
Co KG
18
11%

Others74
45%

Baxter Biopharma
Solutions
11
7%

Catalent Inc
10
6%

Jubilant
HollisterStier LLC
3
2%
Siegfried HoldingAG
42%

Pfizer Inc
8
5%

PCI Pharma
Services
42%

Almac Group Ltd
5
3%

Ajinomoto Bio-Pharma
Services
42%AlbanyMolecular
Research Inc
5
4%
Others65
59%

Catalent Inc
5
4%
Gland Pharma Ltd
4
4%

Cenexi SAS
3
3%

Pfizer Inc
4
4%
Cadila Healthcare
Ltd
3
3%

BaxterBiopharma
Solutions3
3%

Ajinomoto BioPharma Services
33%

Source: GlobalData New Drug Approvals and Their Contract Manufacture – 2021 Edition

GAINING AN EARLY ADVANTAGE AND
PREPARING FOR THE FUTURE

CHOOSE FROM A BROAD RANGE OF STERILEDOSE FORMS TO MEET YOUR UNIQUE NEEDS

Working with Thermo Fisher in early development means
taking advantage of a full range of fast, flexible clinical batch
manufacturing services. Our years of experience, anindustry-leading inspection record and our 89% Right theFirst Time performance give you confidence that yourmolecule is prepared for success. In addition, our integrated
services position you for the fastest and most efficient pathto market in later phases.

Flexibility, speed, expertise, and experience are needed toadvance your sterile injectable drug product from the preclinical phase to approval. Let us help you transform yourdiscovery into a drug product with the best chance forapproval by leveraging:

Our clinical batch manufacturing services include:࡟ Flexible approaches to maximize speed and cost࡟ Formulation and process development
optimization for cost and quality
࡟ Single-use, disposable technology࡟ cGMP manufacturing at all scales࡟ Proven technology transfer experience࡟ Small molecules and biologics

࡟ Scalability to commercial manufacturing࡟ Oral solid, sterile and softgel dosage options

࡟ Strong regulatory track record࡟ Quality by Design (QbD) process development

With extensive sterile injectables experience, we understandthe unique challenges of sterile injectable development andoffer a broad range of capabilities to address the specificneeds of your drug product including:࡟ Full analytical support and stability testing࡟ Over-encapsulation and matching placebos࡟ Materials for dose escalation studies࡟ Registration batches࡟ Small and large volume parenterals࡟ CMC documentation for regulatory submissions

࡟ Liquid filled vials
࡟ Lyophilized vials࡟ Extensive range of vial sizes including ISO standard࡟ Pre-filled syringes and cartridges

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TECHNOLOGY TRANSFER—THE OPPORTUNITY
FOR PROCESS AND PRODUCT IMPROVEMENT
While many CDMOs see technology transfer as a complex
process that often goes wrong, we see it as a way to capture
an advantage. In fact, we believe that when planned for andexecuted correctly, it can lower manufacturing costs andimprove process robustness and efficiency.

THE FINAL PUSH FOR REGULATORY APPROVALSTARTS AT THE BEGINNING
Depth of expertise and resources. Responsiveness and flexibility. Dependable quality. Parallel active pharmaceuticalingredient (API) and finished dose development. Right First
Time/On-time reliability.
That’s what our experts bring to your project. And it also
explains why from 2011-2020 we helped our clients earn 24
new drug application (NDA) approvals for sterile injectables.
More than any other CDMO.

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INTEGRATED
OFFERING

Achieving a fine balance of
speed, efficiency and scale atevery stage.
The journey from early stage through Phase IIb/III clinical
trials and ultimately to commercialization is long, complex,
and costly. But there are people who understand yourmolecule and the road ahead. They know speed is critical,
that risk must be managed at every stage, and that eachchallenge must be overcome before it becomes a problem.
These are the scientists, engineers and professionals ofThermo Fisher Scientific. Who apply a science-driven, riskbased approach to every stage and phase of the development
process. Who draw on years of experience. And who partnerwith you from the earliest stages of formulation development
to maximize the potential for early approval success while
ensuring your manufacturing processes are scalable all theway to commercialization. Because they believe this is thebest way to make certain your discovery lives up to its
promise to the patients who need it most.

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QUICK TO CARE™
INTEGRATED OFFERING

Integrated drug development and clinical services for new and emerging pharma.
The path through drug development is marked by detours, roadblocks and very few shortcuts. At times you may feel thatyou’re the only person keeping your molecule on its critical path. Unexpected delays can lead to missed milestones, reworkand delayed timelines—all setbacks that no one wants to explain to their investors.
Coordination across multiple vendors is extremely complex and requires constant attention. Multiple agreements must be
negotiated. Multiple and differing quality procedures have to be reconciled. Getting multiple vendors, some of whom arecompetitors, to coordinate their activities into a single project can be challenging.
Also, in a multi-vendor scenario, who really “owns” and absorbs your program’s risk? Who among your multiple vendors isthinking creatively about ways to mitigate your project’s risk across the entire development process?
The solution? Our Quick to Care™ program.

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Give your molecule the best
shot at success.
The Patheon™ Quick to Care™ program delivers a streamlined
drug development program, designed specifically for new
and emerging companies. This program combines yourdrug substance and drug product development, clinicalmanufacturing, forecasting, demand planning and clinical
trial supply chain into a single solution to accelerate yourdiscovery to approval.
Benefits of Patheon™ Quick to Care™ integrated offering
include:࡟ Acceleration of development timelines
࡟ Simplified supply chain࡟ Reduced risk
Time savings of 14 weeks have been accomplished byhaving integrated timelines, cross-site collaboration andthe elimination of duplicative work. Simplicity is achieved byestablishing a streamlined supply chain with a single
partner, having combined and integrated proposals, a
single MSA, harmonized quality agreements, consolidated
invoicing and vendor managed transportation. Reduced
risk focuses on having a central focal point and accountability, expertise and experience leveraged across the
network and centralized logistics and storage with enhanced
liability coverage.

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INTEGRATED
OFFERING

HOW IT WORKS
Comprehensive program management with a single
point of contact
Your Quick to Care™ program manager is your single pointof contact who manages all communication and yourmolecule’s critical path. They create, oversee and actively
lead a collaborative molecule team of scientific and processexperts across drug substance and drug product areas. All
quality, safety, technology, and logistics issues flow throughthe program manager. This role was designed specificallyfor new and emerging pharma companies that run lean.
Assurance of supply means reduced risk
An additional service offered within the Quick to Care™
offering is our end-to-end demand planning which calculates
the need for drug substance, drug product and clinicaldemand. This decreases the risk of stock-out situations
which can put development timelines at risk.

On average, Quick to Care™
clients saved 14 weeks off
drug development timelines.
Whether your project is starting at chemical
synthesis or formulation, we’re ready to bringnew molecules into our industry-leading, singlevendor drug development and clinical supply
solution. Contact us today and let us show you
how our Quick to Care™ program can give yourmolecule the best shot at success.

CLINICAL TRIAL LOGISTICS COMMERCIALOTC AND
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Holli Carlson
Director, Commercial Solutions,Pharma Services
Mt. Prospect, IL

HOW SPRING BREAK HAD TO WAIT A LITTLE LONGER,
SO A BABY COULD HAVE A BETTER SHOT.
After a long night of packing for her family’s spring break vacation, Holli woke up at 4:40 AM Saturday morning. She noticed
a text message on her phone. A six-day-old baby experiencing violent seizures needed a client’s medication immediately.
Vacation was going to have to wait. By 5:20 AM, Holli was on the phone with the client to identify a solution. By 7:30 AM, sheand her team were at the site (normally closed on Saturdays). The client had received an emergency Treatment IND from the
FDA the night before. Next, through Thermo Fisher’s Total Transportation Management capability, they were able to arrange
same-day shipment from their TSA-certified warehouse. No red tape. No delay. No package opening at the airport. The package
went directly on a commercial flight, and was hand delivered to the hospital 12 hours after Holli received that text. Best of all,when every moment mattered most, a baby in urgent need could be treated with the client’s medication in hours instead of days.

28

CLINICAL TRIAL
SOLUTIONS

The drug development landscape has changed. Our commitment
to best-in-class clinical trial solutions has not.
Nowhere is this more evident than in clinical supply management. Companies are recognizing the strategic importance ofclinical supplies in ensuring drug development risks and costs are well understood and anticipated. Upfront planning has
become a critical component in executing a streamlined, efficient and nimble clinical supply chain. As such, clinical supply
professionals are playing a more active role in development and study planning, managing mission critical activities,
forecasting and mitigating operational risk.
For over 30 years, the Thermo Fisher Scientific team has been committed to helping clients of all sizes develop comprehensive
clinical supply plans that incorporate the need for flexibility in trial execution with a balanced risk and cost approach. From
complete clinical supply plans, to comparator sourcing strategies, distribution strategies and packaging design
recommendations, our experts are on hand to meet any of your strategic planning requirements.

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Robust Patheon™ Fisher
Clinical Services supply
chain solutions to meetyour clinical trial needs.
SM

PACKAGING DESIGN & PRODUCTION eeping the patient in mind is key to identifying the optimal
Kpackaging configuration for your trial. Our team of project
managers, in combination with our packaging engineers, canassist you in identifying the most suitable packaging for yourclinical trial in order to ensure patient safety and compliance.
Services include: Primary, Secondary, Over-encapsulation,
Pre-filled syringe, Tamper-evident, Blinding, Climate-controlled(including Cold Rooms)

LABELING
Whether needing to implement an Approved Phrase Library(which has been shown to shorten label cycle times by morethan 50 percent) or determining the appropriate label type,text and strategies for your trial, our experienced and dedicated label project management teams can help you build
the strategy that will deliver results both long and short term.
Services include: Booklet, Single & Multi Panel, Digital,
Alternative Translation & Label Approval System (ATLASSM)

BIOSERVICES
Ensuring a seamless workflow which connects the sponsor,
bio-manufacturer, clinical center, and patient into a wellcoordinated chain of custody is our specialty. As the leader
in managing critical biological material, we provide ourcustomers with customized solutions to store, package,and transport their valuable material.
Services include: Biobanking & Biorepository, Laboratory
Processing, Qualification / Validation, Kit Production, Cold
Chain Logistics

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GLOBAL DISTRIBUTION

CLINICAL SUPPLY OPTIMIZATION

Given the ever-expanding global nature of today’s clinical
trials, sponsors demand and deserve the assurance that
their needs will be met regardless of location, and inaccordance with a consistent global quality standard. Our
29 purpose-built cGMP/GDP-compliant facilities, supportedby over 45 partner depots—located across five continents—
provide the global presence, information systems andquality standards to provide clients the flexibility, accessand assurance needed for their clinical trial.

Leveraging the expertise of a dedicated supply chain team,proprietary technology tools and an extensive cGMP
network, we provide proactive guidance in the developmentof supply strategies, as well as overarching simulation,
forecasting and cost management. This team ofprofessionals can assist you in identifying the optimal
packaging configuration, establishing and verifying IRT
setup, forecasting patient clinical supply requirements bycountry and identifying the regulatory hurdles you will facebased upon your current country selection.

Services include: Ambient, refrigerated and cold storage,
controlled substance storage, GDP distribution services toover 150 countries

Services include: Forecasting, End-to-End Supply Chain
Management, Centralized Project Management, Consolidated
Reporting

TOTAL TRANSPORTATION MANAGEMENTManaging the transportation of life science shipments has
become increasingly complex over the years, with patient
pools expanding, often to remote locations across theglobe. In addition, the growth of biologics creates additional
supply chain challenges due to cold chain handling, storage
and distribution requirements. Our logistics specialists andteams of in-country experts can simplify the complexity
associated with transportation planning and monitoring
and, as a result, optimize transportation performance andcosts across the supply chain.
Services include: Supplier Qualification, Mode Optimization, Courier Selection & Management, Customs &Regulatory Guidance, Importer of Record, Cold Chain
Supplies Management, Dispatch Services, Proactive Track& Trace, Data-Objective Monitoring & Reporting, andConsolidated Billing

CLINICAL ANCILLARY MANAGEMENT
It’s easy to forget about ancillaries when immersed in thedetails of a global clinical supply chain. Our dedicated teamof clinical ancillary project managers can help you develop
a complete ancillary strategy that will ensure your sites areappropriately stocked at time of First Patient In and inaccordance with regulatory requirements.
Services include: Sourcing, Inventory Management,
Distribution, Ancillary Returns Management
Qualified Person Services
For strategic planning purposes, our team of QPs areavailable to provide advice on your expiry strategy, including
the most current conditions required by regulatory authorities.
Services include: Regulatory Oversight, Compliance
Guidance

COMMERCIAL DRUG SOURCING
Sourcing comparator, rescue medication, or co-medication
for clinical trials is not merely a purchasing or procurement
exercise. Applying a strategic approach, evaluating every
sourcing factor and creating a customized plan with multiple
options results in an optimal comparator sourcing strategy.
Services include: Comparator, Co-medication, Rescue
medication sourcing

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Angie West
Global Relationship Director,
Pharma Services
Allentown, PA

HOW A COMBINATION OF TEAMWORK, HEART, AND
SCIENCE ENSURED THOUSANDS OF PATIENTS AROUNDTHE GLOBE DIDN’T GO WITHOUT MEDICINE.
Angie will never forget the day she got a call from a client with a packaging and logistics challenge of global proportions. They
needed her help figuring out how to get an oncology drug labeled for 60,000 patients in 35 countries every month. And theyneeded that solution to fit in a four week cycle – half the time typically required to turn around a trial of that scale. So, Angie
pulled together a team of experts across 10 departments to break down every step of the process. They worked long hours
and explored every possible opportunity to increase efficiencies and take time out of the process. Then they set up an
operator training lab to ensure everyone on the team could deliver the new solution as planned. The result was a 55%
reduction in cycle times and thousands of patients around the world received the life-saving medication they needed.

32

SECTION I 		SECTION II 		SECTION III

LOGISTICS SERVICES

Partner with our team of logistics experts to take on your toughest challenges.
When storing and transporting pharmaceutical products and materials there are significant, non-negotiable requirements:
temperature management to protect product integrity, mandated licenses and certifications, systems and processes that
conform to regulatory guidelines, and end-to-end security of the supply chain.
For over 30 years, we have provided industry-leading logistics services with impeccable quality standards to satisfy andprotect our clients and the patients they serve. We help our customers deliver a risk controlled and efficient supply chain
between development and manufacturing sites, clinical investigators and patients worldwide. Given this extensive
background in managing pharmaceutical products, our clients trust us to execute clinical trial and commercial productdeliveries on time, every time. We find the most cost-effective option to ensure product integrity, regulatory compliance andshipment security while maintaining impeccable end-to-end quality standards.

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Specialized logistics
services to make yourmost complex supply
demands more efficient.

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SOLUTIONSEARLY ANDLATE PHASE
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INTEGRATED
OFFERING

SPECIALTY WAREHOUSING
Whether storing bulk API, commercial drug marketing samples
or specialized trade product, our GMP/GDP-compliant
distribution centers are specifically designed to meet thedemanding needs of today’s pharmaceutical companies.
We ensure optimal quality and capacity by employing
advanced automation, including pick-to-light / put-to-lightsystems and RF technology. We have made significant
investments in support of the increased demand for cold
chain services by expanding our refrigerated/frozen storage
and providing zero Time Out of Environment (TOE) pick andpack solutions. Our continued investment in cold chain
storage and distribution mirrors the industry’s evolution
towards complex cold chain therapies.

CLINICAL TRIAL LOGISTICS COMMERCIALOTC AND
GLOBAL SITE
SOLUTIONSSERVICES MANUFACTURING SOFTGEL
NETWORKTECHNOLOGIES34

࡟ cGMP, GDP, PDMA and Drug Supply Chain
Security Act (DSCSA) compliant processes

Services include: Sample request processing, ordermanagement, fulfillment and distribution services,transportation management including appointment-based
deliveries, proactive track & trace for cold chain shipments,
acknowledgement of contents and signature verification
services and returns management.

࡟ Licensed per 21 CFR 205.4, 205.5 and 205.6 todistribute prescription drug products

GLOBAL TRANSPORTATION SOLUTIONS

Our distribution centers are highly secure and fully climate
controlled, featuring:࡟ A validated Warehouse Management System࡟ Wholesale distribution licenses to all 50 US states
࡟ DEA Class III – V, TSA and VAWD certification࡟ Designated areas for quarantined/high-levelsecurity storage࡟ Managed environments for ambient(15°C to 30°C), refrigerated (2°C to 8°C) andfrozen (-25°C to -10°C) storage
Services include: Comprehensive environment and security
management, validated warehouse management system,
ambient through frozen storage, zero time out of environment
cold chain pick and pack and designated secured areas forquarantined and controlled substance storage

COMMERCIAL DRUG MARKETINGSAMPLE PROGRAMS

We are the industry leader for the delivery of samples,managing the largest sample-send programs in North
America. We have managed over 3 million annual direct-topractitioner shipments with over 53 million individual
product units picked. Our track record includes a pickaccuracy over 99.9%, 99%+ on-time service and 99% of
shipments delivered without damage or loss.

LARGE
MOLECULEDRUG
SUBSTANCECAPABILITIESADVANCED
CELL ANDGENE
THERAPY
SOLUTIONSEARLY ANDLATE PHASE
DEVELOPMENTCAPABILITIESWe provide a consultative solution design focused on
defining client and situation-specific needs, driving costsavings and reducing time-in-transit. We provide a costeffective service through the flexibility of our offerings andby leveraging corporate resources and carrier/supplier
agreements. Industry certifications include:࡟ GDP Certified

For over 30 years, life science companies have partneredwith us for commercial sample distribution because of
our logistics expertise and unmatched track record ofdelivery to representatives in the field or directly tohealthcare practitioners.

SMALL
MOLECULEDRUG
SUBSTANCECAPABILITIESPharmaceutical companies require that their life science
shipments be transported with the highest possible security
while ensuring product integrity. We leverage a global
network of quality-vetted providers to deliver specialty
logistics solutions that effectively leverage available
resources of air, ocean and surface transportation. Our
GDP-compliant services span the entire product development life cycle, from bulk active pharmaceutical ingredientsand clinical trials materials, to product commercialization
samples and finished goods.

QUICK TOCARE TM
INTEGRATED
OFFERING

࡟ C-TPAT Certified
࡟ IATA Accredited Cargo Agent࡟ TSA-certified Indirect Air Carrier
࡟ US DOT Registered Hazmat Carrier࡟ World Cargo Alliance (WCA) First Member &Pharma Member
Services include: Air, ocean, ground and parcel, ambient
through ultra-cold temperature management (15°C to 25°C,
2°C to 8°C, -20°C, -80°C and LN2), on-line status visibility
including GPS tracking, 24/7/365 support and quality-vetted
life science specific provider network

CLINICAL TRIAL LOGISTICS COMMERCIALOTC AND
GLOBAL SITE
SOLUTIONSSERVICES MANUFACTURING SOFTGEL
NETWORKTECHNOLOGIES35

Jigal ShahBusiness Manager,
Pharma Services
Whitby, Ontario

Jessica Morin
Portfolio Services Manager,
Pharma Services
Whitby, Ontario

HOW DIGGING DEEP INTO CANADIAN REGULATIONSGOT A CLIENT’S MEDICATION ONTO SHELVES IN BRAZIL.
A medication made in Thermo Fisher’s Whitby, Canada site needed to be on shelves in Brazil by July 4, or the client would
lose the right to sell the medicine in that country entirely. But the delivery vendor made a mistake and delivered the productto Mexico instead. Jessica and Jigal teamed up to work through the options. They could do another production run in Canada
on short notice, but it still wouldn’t meet their deadline. They couldn’t ship from Mexico to Brazil because Mexican customs
would delay the process for too long. So, they took a step back and looked deeper into the regulations to find a better andquicker solution. The 10% of the run that had been kept at the plant in Canada was able to be shipped to Brazil by thedeadline and still comply with Brazil’s regulations. The product arrived on shelves in Brazil by the end of June, and the client
was able to deliver this life-changing medication to patients that never had access to it before.

36

COMMERCIAL
MANUFACTURING

Our experience and expertise can make your most complex discoveries
a commercial reality.
Your molecule has proven itself, cleared innumerable hurdles and now it’s time to introduce it to the world. This is no time
to take risks. First and foremost, Thermo Fisher Scientific offers you a trusted partnership. People, facilities and processes
that have built a reputation for quality and innovation for over 50 years.
These are the people who deliver more than 100 dosage forms. Who are focused on the client experience—delivering ontime and Right-The-First-Time.

SMALL
MOLECULEDRUG
SUBSTANCECAPABILITIESLARGEMOLECULEDRUG
SUBSTANCECAPABILITIESADVANCED
CELL ANDGENE
THERAPY
SOLUTIONSEARLY ANDLATE PHASE
DEVELOPMENTCAPABILITIESQUICK TOCARE TM
INTEGRATED
OFFERING

CLINICAL TRIAL LOGISTICS COMMERCIALOTC AND
GLOBAL SITE
SOLUTIONSSERVICES MANUFACTURING SOFTGEL
NETWORKTECHNOLOGIES37

INNOVATIVE CAPABILITIES FROM BUSINESSMODELS TO MANUFACTURING TECHNOLOGY
Thermo Fisher puts you on the frontier of new technologies
and business models which include offerings such ascontinuous manufacturing and condominium manufacturing
suites. And we provide a smooth transition from early
development all the way to commercialization and productlifecycle management.

ORAL SOLIDS
We provide access to a wide range of conventional andspecialized oral solid dosage form capabilities and scale.
Further expand your options with innovative combinationsof these forms and a variety of controlled-release technologies. All these choices are executed with expansive
scientific resources, expertise in complex formulations suchas solubility enhancement and capabilities for highly potent
compounds and controlled substances.

SOFTGELS
Discover the many clinical and technical advantages ofsoftgels with a host of patent-protected specialized technologies. These include advanced solutions for enhancing
solubility and bioavailability, as well as unique controlledrelease and oral delivery technologies. Our experience
covers both development of prescription (Rx) products andideation sessions to ensure brand sustainability for overthe-counter (OTC) products. Create a pro-duct that stands
out in the marketplace with a broad palette of shapes, sizes
and colors.

SMALL
MOLECULEDRUG
SUBSTANCECAPABILITIESLARGEMOLECULEDRUG
SUBSTANCECAPABILITIESADVANCED
CELL ANDGENE
THERAPY
SOLUTIONSEARLY ANDLATE PHASE
DEVELOPMENTCAPABILITIESQUICK TOCARE TM
INTEGRATED
OFFERING

STERILE INJECTABLES
Gain access to extensive pharmaceutical development andmanufacturing capabilities at all scales. We offer specialized
expertise in formulation development, lyophilization, cycle
development, process development and scale-up. We provide
a broad range of equipment that easily scales from small
quantities for early development clinical trials and smallvolume commercial products, to large-volume clinical trial
material and commercial products. Options include
disposable (single-use) manufacturing technologies as wellas traditional stainless steel equipment are available. You’llalso have access to state-of-the-art, cGMP manufacturing
capabilities for prefilled syringes and cartridges.

COMMERCIAL PACKAGING
Collaborate with one end-to-end supply chain provider
from manufacturing to clinical through commercial. We
have packaging lines throughout our global network, withthe flexibility to support small or large volumes. Our
experience and expertise adds value throughout the
packaging life cycle. Our broad capabilities include bottle,
blister, sachet, vial, ampoule, syringe and kit assembly.

CLINICAL TRIAL LOGISTICS COMMERCIALOTC AND
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NETWORKTECHNOLOGIES

38

SPECIALIZEDORAL SOLIDS

Bilayer tablets

2 IRs or IR+CR/SR fixed-dose combination.

Trilayer tablets

3 IRs or IR+placebo+CR/SR
fixed-dose combination.

Microtablets

IR or CR/SR, low-dose tablets; via
device, capsule or sachet.

Tablets in capsules

IR or CR/SR, over-encapsulation
for blinded clinical supply.

Chewable tablets

Fast-dispersible tablets

Sublingual tablets

Beads in hard-shell capsules

Liquid-filled capsules

Laser-drilledcontrolled-release tablets

CONVENTIONAL
ORAL SOLIDSEARLY ANDLATE PHASE
DEVELOPMENTCAPABILITIESQUICK TOCARE TM
INTEGRATED
OFFERING

IRs and/or CRs/SRs fixed-dose combination,
uncoated or polymer coated; extrusion,
spheronization or drug layering.
IR or CR/SR, hard shell, options to improvesolubility, bioavailability and absorption.
Ideal for Phase I and beyond.
CR/SR, osmotic, zero-order, controlled-releaseover a defined time period.

Polymer matrix

Controlled-release technology.

Wax matrix

Controlled-release technology.

Pulsatile release

Controlled-release technology.

Polymer coating

Controlled-release technology.

Tablets

ADVANCED
CELL ANDGENE
THERAPY
SOLUTIONS

IR, single-layer tablets for
sublingual administration.

Controlled-release technology.

Powders, granules,
coated beads and multiparticulates

LARGE
MOLECULEDRUG
SUBSTANCECAPABILITIES

IR, disintegrates/disperses as suspension
in water, divisible into 4 parts fortitration. Ideal for pediatrics.

Hydrophilic gel matrix

Powder-filled capsules

SMALL
MOLECULEDRUG
SUBSTANCECAPABILITIESIR or CR/SR, single or bilayer fixeddose combinations. Ideal for pediatrics
and high-dose compounds.

IR or CR/SR, single-layer tablets, coatedor uncoated, with or without break line orembossing, range of shapes and sizes.
IR, two-piece gelatin or HPMC capsules in arange of sizes and multiple color combinations.

IR, packaged in bottles and sachets ofvarying dimensions and fill weights.

CLINICAL TRIAL LOGISTICS COMMERCIALOTC AND
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NETWORKTECHNOLOGIES

39

STERILEINJECTABLES

Liquid-filled vials• Aseptic filling, terminal sterilization when required.
• Extensive range of vial sizes, including ISO standards.
• Batch sizes to meet product demand.
• Disposable (single-use system) manufacturing options.
• Glass or polymeric vials available.

Lyophilized vials• World-class scientific expertise to develop.
and optimize lyophilization cycles.
• Disposable (single–use system) manufacturing options.
• Extensive range of vial sizes, including ISO standards.
• 800 m2+ of global lyo capacity.

Prefilled syringes
and cartridges• Aseptic filling, terminal sterilization when required.
• Broad range of sizes and configurations.
• Disposable (single–use system) manufacturing options.
• Small and large batch sizes available.
• Glass or polymeric options available.

Sterile injectables
clinical services• PFS plunger and backstop assembly.
• Needle safety device assembly.
• Auto-injector assembly.
• PFS and reference material blinding.

Biologic andsensitive molecules

STERILEDOSAGE FORMSCOMMERCIALAND DEVELOPMENT

GREENVILLE,
NC, USA• Peristaltic pumps.
• Cold chain storage and distribution.
• Assembly, packaging, and labeling at 2ºC - 8ºC.
• Filling under nitrogen.

FERENTINO,ITALYMONZA,ITALY

GREENVILLE,
NC, USA

Development

FERENTINO,ITALYMONZA,ITALY

Commercial

Liquid vials

2 ml – 20 ml

2 ml – 100 ml

2 ml – 100 ml

2 ml – 65 ml

2 ml – 500 ml

2 ml – 100 ml

Lyophilized vials

2 ml – 20 ml

2 ml – 20 ml

2 ml – 100 ml

2 ml – 65 ml

2 ml – 25 ml

2ml – 100 ml

PFS / cartridges

0.5 ml – 20 ml

0.5 ml – 20 ml 0.5 ml – 20 ml

0.5 ml – 20 ml

1. ISO and Non-ISO vials can be accommodated.
2. Additional vial sizes available and can be shared by a Thermo Fisher representative.
3. Development scale manufacturing capabilities suitable for clinical trial material manufacturing.
4. Disposable (single-use system) manufacturing options available.
5. New capabilities are continually being added. A detailed list of current capabilities can be made available on request.

GMP
LYOPHILIZATIONCAPABILITIESGREENVILLE, USA

Total

SMALL
MOLECULEDRUG
SUBSTANCECAPABILITIESLARGEMOLECULEDRUG
SUBSTANCECAPABILITIESFERENTINO, ITALYMONZA, ITALY

Development Commercial Development Commercial Development Commercial

ADVANCED
CELL ANDGENE
THERAPY
SOLUTIONSEARLY ANDLATE PHASE
DEVELOPMENTCAPABILITIESQUICK TOCARE TM
INTEGRATED
OFFERING

1 x 2 m2
2 x 7 m2

1 x 25 m2
5 x 28 m2
2 x 30 m2
1 x 60 m2

16 m2

285 m22 x 7 m2

1 x 10 m2
2 x 20 m2
1 x 33 m2
1 x 42 m2

2 x 7 m22 x 29 m2
2 x 33 m2
2 x 37 m2
4 x 40 m2

14 m2

125 m214 m2358 m2

CLINICAL TRIAL LOGISTICS COMMERCIALOTC AND
GLOBAL SITE
SOLUTIONSSERVICES MANUFACTURING SOFTGEL
NETWORKTECHNOLOGIES40

SOFTGELS
Softgel capsules

Soflet® gelcaps

EnteriCare® enteric softgels

Chewels® chewable gels

Twist-off softgels

OVAL
OBLONGROUND• Patented technology enrobes tablets.
• Broad array of color and imprinting choices.
• Safely encases highly potent compounds.
• Perfect for clinical trial blinding.
• Enteric properties are integrated into the gelatin shell.
• Reduces risk of reflux and gastric irritation.
• Protects acid-labile compounds.
• Compatible with SMEDDS, hydrophilic and viscous fills.
• Chewable for patient comfort and convenience.
• Rapid onset of action and relief of symptoms.
• Ideal for pediatric and geriatric markets.
• Patented technology.
• Available in lozenge form.
• Precise unit dosing for oral liquid and topical products.
• Hermetic seal helps preserve API.
• Portable convenience improves patient compliance.
• Consistent dosing for reliable results in clinical trials.

Versatrol™
controlled-release softgels• Unique matrix system to fine-tune release.
• Controlled-release capabilities integrated into fill.
• Lipophilic and hydrophilic formulations.
• Suitable for compounds with low solubility.

Solvatrol™
enhanced solubility softgels• Enhances solubility and bioavailability.
• Lipophilic and hydrophilic formulations.
• Provides a stable solvent delivery system.
• Reduces plasma level variability.

LiquiSoft™ chewableliquid-filled softgels

SOFTGELSHAPES
AND SIZES• Immediate-release soft gelatin capsules.
• Clinical development scale production.
• 13.7B capsule commercial manufacturing capacity.
• Extensive range of sizes, colors and imprinting options.

• Solid dose for oral liquid formulations.
• Soft, chewable shell with a pleasant burst of liquid.
• Enhances performance of poorly soluble compounds.
• Flavors and aromas mask unpleasant tastes and odors.

CAPSULESREQUIRED CONTAINER SIZE (CC) BY FILL COUNT

Size

Fill volume range (CC)

60 count

100 count

250 count

500 count20.089-0.111

60

60

75

150

3

0.182-0.228

60

75

120

200

4

0.209-0.261

60

100

150

250

5

0.312-0.389

75

100

150

300

6

0.318-0.397

75

100

150

400

7.5

0.386-0.482

75

100

225

400

9

0.469-0.586

100

120

300

600

10

0.567-0.709

100

120

300

600

3

0.181-0.227

75

75

200

350

4

0.243-0.304

100

120

250

400

5

0.285-0.356

100

120

300

750

6

0.338-0.422

100

120

400

750

8

0.452-0.564

120

200

500

950

14

0.863-1.079

200

300

750

1250

16

0.975-1.218

250

400

950

1500

2

0.073-0.123

60

60

75

150

3

0.138-0.183

60

75

120

200

4

0.173-0.244

60

100

150

250

5

0.195-0.305

75

100

150

300

6

0.279-0.367

75

100

150

400

7

0.305-0.428

75

100

225

400

15

0.737-0.922

150

225

500

750

Other shapes and sizes available. Formulation can affect options.
SMALL
MOLECULEDRUG
SUBSTANCECAPABILITIESLARGEMOLECULEDRUG
SUBSTANCECAPABILITIESADVANCED
CELL ANDGENE
THERAPY
SOLUTIONSEARLY ANDLATE PHASE
DEVELOPMENTCAPABILITIESQUICK TOCARE TM
INTEGRATED
OFFERING

CLINICAL TRIAL LOGISTICS COMMERCIALOTC AND
GLOBAL SITE
SOLUTIONSSERVICES MANUFACTURING SOFTGEL
NETWORKTECHNOLOGIES41

A WORLD OF DOSAGE FORMSNORTH AMERICA
Bend,
USA

Cincinnati,
USA

High
Point,
USA

Greenville, Toronto,
USA
CanadaEUROPE
Whitby,CanadaManati,
PuertoRico

Bourgoin,
FranceMonza,
Italy

Tilburg,
Ferentino, Milton, Swindon*,NetherItaly
Park, U.K.
U.K.
lands

SPECIALIZEDORAL SOLID DOSAGE FORMS
Bilayer tabletsl

Trilayer tablets

l

l

l

l

Beads in capsules

l

l

l

Coated beads

l

l

l

Tablets in capsules

l

l

l

l

Fast-dispersible tablets

l

l

l

l

Laser-drilledcontrolled-release tablets
Liquid-filled capsules

l

l
l

l

l

l

l

l

l

l

l

l

l

l

l
l

l

Biphasic liquid-filledcapsuleslll

Bilayer chewable tabletslBeads in liquid-filledcapsulesllHydrophilic gel matrix

l

l

l

l

Wax matrix

CONVENTIONALl

Microtablets

Polymer matrix

SOFTGELSl

Pulsatile releasell

Polymer coatingllSublingual tabletsl

Uncoated
CoatedPowder-filled capsules

l

l

l

l

l

l

l

l

l

l

l

l

l

l

l

l

l

l

l

l

l

l

l

l

l

l

l

l

l

l

l

l

l

l

l

l

l

l

l

l

l

l

l

l

l

l

l

l

l

l

l

l

Powders and granules

l

l

l

l

l

l

l

l

Multiparticulates

l

l

l

Spray drying**lllSoftgel capsulesllTwist-off softgelsllEnteriCare® enteric softgels

l

l

l

l

l

l

LiquiSoft™ chewableliquid-filled softgels
Versatrol™ controlledrelease softgels
Solvatrol™ enhanced
solubility softgelsllSoflet® gelcapsllChewels® chewable gelsll

STERILE DOSAGE FORMS
Liquid-Filled vials

l

l

l

Lyophilized vials

l

l

l

Prefilled syringesllPrefilled cartridgesll* Our Swindon site is a Condominium site that builds customized facilities to meet client needs for a variety of dosage forms.
** Commercial capabilities in Florence, SC

SMALL
MOLECULEDRUG
SUBSTANCECAPABILITIESLARGEMOLECULEDRUG
SUBSTANCECAPABILITIESADVANCED
CELL ANDGENE
THERAPY
SOLUTIONSEARLY ANDLATE PHASE
DEVELOPMENTCAPABILITIESQUICK TOCARE TM
INTEGRATED
OFFERING

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GLOBAL SITE
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NETWORKTECHNOLOGIES42

PHARMA SERVICESPACKAGING CAPABILITIESNORTH AMERICAEUROPE

Allentown,
PA, USA

Cincinnati,
OH, USA

Greenville,
NC, USA

Toronto,
Whitby,Manati,ON, Canada ON, Canada Puerto Rico

l

l

l

l

l

l

l

l

l

Bourgoin,
FranceMonza,
Italy

Ferentino,
Italy

Horsham,UK

ORAL SOLID DOSAGE FORMS
Blisters
BottleBlister carton wallet

l
l

l

l

l

l

Pouch / sachetlPowder in bottlellLiquids in bottlel

KIT ASSEMBLY

l
l

l

l

l

STERILES
Pre-filled syringe assemblylSyringe labeling & packaginglVial / ampoule labeling and packaging

l

l

l

l

l

l

l

l

AUTO-INJECTOR
Assembly & packagingl

SERIALIZATION

l

SMALL
MOLECULEDRUG
SUBSTANCECAPABILITIESLARGEMOLECULEDRUG
SUBSTANCECAPABILITIESADVANCED
CELL ANDGENE
THERAPY
SOLUTIONSll

EARLY ANDLATE PHASE
DEVELOPMENTCAPABILITIESlQUICK TOCARE TM
INTEGRATED
OFFERING

l

l

l

l

l

l

CLINICAL TRIAL LOGISTICS COMMERCIALOTC AND
GLOBAL SITE
SOLUTIONSSERVICES MANUFACTURING SOFTGEL
NETWORKTECHNOLOGIESl43

More successful NDA approvals than any other CMO.
Who would you rather trust with your molecule?

More successful
NDA approvals thanany other CMO.

120

117

100

80

WHO WOULD YOU RATHER
TRUST WITH YOUR
MOLECULE?

67
60

40
21

Dose outsourcing: NDA approved products 2011-2020
Source: GlobalData – New Drug Approvals and Their
Contract Manufacture – 2021 Edition

20

21
15

15

15

0

Data does not include NDA approvals for nontherapeutic drugs.

PROCESS VALIDATION—ENSURINGA RELIABLE COMMERCIAL SUPPLY
To help your discovery reach the patients who need it most,on time, we deliver complete process validation inaccordance with regulatory and cGMP guidelines, including:࡟ Process validation with critical parameters

Unlike other CDMOs that tie you to a limited number ofsolutions and services, Thermo Fisher gives you access toa broad range of dosage forms, formulation methods andspecialized technologies to create a successful new productwhile extending your exclusivity.

CONTINUOUS MANUFACTURING—THE NONSTOP ROUTE TO LOWER COSTS
AND HIGHER QUALITY

࡟ Validation of analytical assays
࡟ Hold time studies
࡟ Stability studies at required ICH conditions

Today, Thermo Fisher Scientific is revolutionizing how OSD
medicines are made through continuous manufacturing. In
this process, the raw materials are fed into the process train
and the final product is produced continuously without interruption via an integrated series of unit operations. Our modular
designed, nonstop, fully integrated process is not restricted
to batch size and offers a range of advantages, including:࡟ Container shipment studies
࡟ Release testing࡟ CMC documentation in CTD format

LIFE CYCLE MANAGEMENT—EXTENDING
THE POTENTIAL OF YOUR PRODUCT
Make the most of your investment by maximizing your existingproduct’s lifespan and reach. With the experience of morethan 50 successful life cycle management projects, we canquickly and cost-effectively help you achieve your goals.
࡟ Enhance clinical benefits: Modified releasetechnologies to improve patient compliance andclinical benefits࡟ Reformulate: A new dose form or strength tounlock new markets and indications

࡟ Maximum flexibility to meet unique client productand capacity needs࡟ Real-time monitoring and adjustment to maximize
process control, producing consistent and highquality products, and minimizing batch rejections
࡟ Removing the need for scale up studies andlowering the costs of product development࡟ Smaller facility footprint compared to conventional
batch processing equipment࡟ Synergistic combinations: Combine your API withother drugs to simplify patient complianceor address unmet clinical needs
SMALL
MOLECULEDRUG
SUBSTANCECAPABILITIESLARGEMOLECULEDRUG
SUBSTANCECAPABILITIESADVANCED
CELL ANDGENE
THERAPY
SOLUTIONSEARLY ANDLATE PHASE
DEVELOPMENTCAPABILITIESQUICK TOCARE TM
INTEGRATED
OFFERING

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44

Dosage forms tailored for yourmolecule and your patients.

SMALL
MOLECULEDRUG
SUBSTANCECAPABILITIESLARGEMOLECULEDRUG
SUBSTANCECAPABILITIESADVANCED
CELL ANDGENE
THERAPY
SOLUTIONSEARLY ANDLATE PHASE
DEVELOPMENTCAPABILITIESQUICK TOCARE TM
INTEGRATED
OFFERING

Access to comprehensive dosage forms. A reputation built
on 50 years of experience. More NDA approvals than thenext three leading CMOs combined. A seamless path fromearly development and scale-up of even the most complex
molecules to commercialization. Innovative business models
and technology from condominium manufacturing suites tocontinuous manufacturing. The right form for every patient.

CLINICAL TRIAL LOGISTICS COMMERCIALOTC AND
GLOBAL SITE
SOLUTIONSSERVICES MANUFACTURING SOFTGEL
NETWORKTECHNOLOGIES45

Adamou Seydou
Gelatin Associate,
Pharma Services
High Point, NC

HOW WASTED MATERIAL INSPIRED SAVING TIME AND
MONEY.
When it comes to manufacturing softgel dosage forms, nobody knows more about operating the equipment that makes themthan Adamou. He’s relentless about finding new ways to make the manufacturing process more efficient. So, when he saw
the amount of scrap material being produced during a specific manufacturing process, he was determined to find a way todecrease it. He enlisted the help of a team of experts who supported his cause and they worked after hours and weekends
until they found a solution. The result is a new process that greatly reduces scrap, delivers savings to customers, and mostimportantly, helps to lower the cost of medicines for the patients who need them.

46

SOFTGEL TECHNOLOGIESFOR RX AND OTC

Innovative softgel technologies that maximize your market potential:
Where ideation and expertise come together.
Softgel technologies are becoming an increasingly popular dosage form in both the Rx and OTC markets. With decades ofexperience and capabilities spanning development through commercialization, our softgel experts understand what it takes
to maximize the potential of your product in either market. From our scientists who are skilled in developing softgel
formulations in early development to overcome low solubility challenges, to our manufacturing operators who are relentless
about making the manufacturing process more efficient, you can count on our team to help your project achieve successthrough ideation and partnership.

SMALL
MOLECULEDRUG
SUBSTANCECAPABILITIESLARGEMOLECULEDRUG
SUBSTANCECAPABILITIESADVANCED
CELL ANDGENE
THERAPY
SOLUTIONSEARLY ANDLATE PHASE
DEVELOPMENTCAPABILITIESQUICK TOCARE TM
INTEGRATED
OFFERING

CLINICAL TRIAL LOGISTICS COMMERCIALOTC AND
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Your flexible partner fromdevelopment to commercial.

Thermo Fisher brings value to pharmaceutical and consumer
health care companies through ideation sessions and flexible
business models that can:࡟ Develop product proof of concept to confirm
market interest

Thermo Fisher Scientific offers development and manufacturing capabilities for specialized products including
highly potent drugs, hormones, DEA-controlled substances(schedule I–III) and abuse-deterrent products.
And when existing Rx products need new revenue streams,
product and brand managers can tap into our softgel
expertise and proprietary technologies for new softgel
product formu-lations. We offer cost-effective and flexible
business models ranging from fee for service, to licensing ofexisting products and co-development of proofs of concepts.

SMALL
MOLECULEDRUG
SUBSTANCECAPABILITIESLARGEMOLECULEDRUG
SUBSTANCECAPABILITIESADVANCED
CELL ANDGENE
THERAPY
SOLUTIONSEARLY ANDLATE PHASE
DEVELOPMENTCAPABILITIESQUICK TOCARE TM
INTEGRATED
OFFERING࡟ Provide innovation for product lifecycle
management࡟ Provide solutions for Rx, OTC and tablet tosoftgel switches࡟ Enhance bioavailability to obtain quicker onsetof action࡟ Provide formulation options for specific patient
populations including pediatrics and geriatrics

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Access a range of proprietary
technologies with provenmarket success.
Chewels®
Chewels ® chewable gels are approvedfor pharmaceutical use and are ideal
for pediatric and geriatric populations.
They are also well suited for people
who find swallowing difficult and arelooking for a convenient dosage form
for administration. The chewable gelshave a soft texture and can be chewed
within a minute. No water is needed.
The technology provides an opportunity
for taste masking, adding anotherelement to patient acceptance andcompliance.

Sofgel®
Sofgels ® technology is suitable forliquidformulations,applications
requiring faster onset of action, lowdose products and those with poorbioavailability that would benefit froma lipid system. These capsules areeasy to swallow, and twist-off options
are available.

Soflet® Gelcap
Soflet technology is an excellent
choice to safely encase highly potent
compounds and is particularly suitablefor clinical trial blinding. A broad
palette of colors and imprinting
choices are available.

EnteriCare®
LiquiSoft™
LiquiSoft™ softgels are particularly
suitable for liquid fills that require afast onset of action and/or buccal
absorption. The technology enhances
the performance of poorly solublecompounds and is an accurate, convenient dosage option for oral liquids.
LiquiSoft softgels come in a variety offlavors that mask bad tastes andodors, adding to patient appeal.

With the EnteriCare ® patented technology, the enteric properties areintegrated into the gelatin shell, not a
coating. The result is an elegant, clear
capsule that targets delivery to thesmall intestine, reducing risks of reflux,
gastric irritation, and transformationof acid-labile compounds. EnteriCare
enteric softgels allow for the delayed
release of your compound with theclear-dosage form consumers prefer.1

Ask your Thermo Fisher representative about our portfolio
of products and technologies available for out licensing.

1 Quantify Consumer Perceptions and Preferences Relative to Oral Product Dosage Forms in OTC Pharmaceutical and Nutritional.

SMALL
MOLECULEDRUG
SUBSTANCECAPABILITIESLARGEMOLECULEDRUG
SUBSTANCECAPABILITIESADVANCED
CELL ANDGENE
THERAPY
SOLUTIONSEARLY ANDLATE PHASE
DEVELOPMENTCAPABILITIESQUICK TOCARE TM
INTEGRATED
OFFERING

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GLOBAL SITE
NETWORK
North America

API

API
Biologics

Biologics
Cell
Therapy

Cell TherapyViral VectorPlasmids
Plasmids
Development

Viral Vector
Softgel••Alachua,
Florida,USA USA
Alachua,
Florida,Allentown, Pennsylvania, USA

Allentown, Pennsylvania, USA

Bend, Oregon, USA

Bend, Oregon, USA•

Bohemia, New York, USA

Bohemia,
New York, USA
USA
Cambridge,
Massachusetts,••

Carlsbad,
California,
USA*
Cambridge,
Massachusetts,
USA•

Cincinnati, Ohio, USA

Carlsbad, California, USA*

Florence, South Carolina (East), USA

Cincinnati, Ohio, USA

Florence, South Carolina (West), USA

Florence,
South Carolina(East), USA
Franklin,
Massachusetts,
USA

•
•

Frederick,
Maryland,USA
Florence,
South
Carolina (West), USA

Franklin, Massachusetts, USA
Frederick, Maryland, USA

Clinical Trial
Specialty

Solutions
Warehousing

•
•

•

•

•

•
•

•
•

Greenville, North Carolina, USA•

Indianapolis, Indiana, USA

•

••

•

•

•

•

Manati,HighPuerto
Point,Rico
North Carolina, USA
Memphis, Tennessee, USA

Indianapolis, Indiana, USA

Mt. Prospect, Illinois, USA

Lexington, Massachusetts, USA••

Plainville, Massachusetts, USA•

Manati,
PuertoRico
Princeton,
New
Jersey,USA

Specialty
Warehousing

•

••

•

Commercial
Manufacturing••

High Point, North Carolina, USA

Greenville,
South Carolina,
USA
Lexington,
Massachusetts,
USA

Commercial
SoftgelManufacturing•••

Greenville, North Carolina, USA

Greenville, South Carolina, USA•

Solutions•••

Clinical Trial
Development

•

•

•

•

•
•
•

•
•

Rockville,
Maryland,USA
Memphis,Tennessee,
USA

•

•

San Francisco, California, USA*

Mt. Prospect, Illinois, USA

Somerville, Massachusetts, USA

Plainville, Massachusetts, USA•

St. Louis, Missouri, USA

Princeton,
New
Jersey,Swedesboro,
New
Jersey,USA USA

•

•
•

•

•
•

Toronto,Ontario,
CanadaRockville,
Maryland,USA•

Vacaville, California, USA

San Francisco, California, USA*

Watertown, Massachusetts, USA

Somerville,
Massachusetts, USA
Whitby,Ontario, Canada•

St. Louis, Missouri, USA

•
•

•

•

•
•

•
•

Swedesboro, New Jersey, USA•

Toronto, Ontario, Canada•

Vacaville, California, USA
Watertown, Massachusetts, USA
Whitby, Ontario, Canada

SMALL
MOLECULEDRUG
SUBSTANCECAPABILITIESLARGEMOLECULEDRUG
SUBSTANCECAPABILITIES•ADVANCED
CELL ANDGENE
THERAPY
SOLUTIONSEARLY ANDLATE PHASE
DEVELOPMENTCAPABILITIESQUICK TOCARE TM
INTEGRATED
OFFERING••

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GLOBAL SITE
NETWORKSouth America

API

Biologics

Cell Therapy

Buenos Aires, Argentina
Lima, Peru
Santiago, Chile
Sao Paulo, Brazil

LARGE
MOLECULEDRUG
SUBSTANCECAPABILITIESViral Vector

Development

SoftgelClinical trial
Solutions

Commercial
Manufacturing

Specialty
Warehousing

•
•
•
•
•

Bogota, Columbia

SMALL
MOLECULEDRUG
SUBSTANCECAPABILITIES

Plasmids

ADVANCED
CELL ANDGENE
THERAPY
SOLUTIONSEARLY ANDLATE PHASE
DEVELOPMENTCAPABILITIESQUICK TOCARE TM
INTEGRATED
OFFERING

CLINICAL TRIAL LOGISTICS COMMERCIALOTC AND
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GLOBAL SITE
NETWORK
EuropeAPI

Biologics
API

Basel, Switzerland

Biologics

Cell Therapy
Cell Therapy

Plasmids
Plasmids

Viral Vector
Viral Vector

Development
Development

Clinical trial
Solutions

Softgel••Basel, Switzerland
Bishop’s Stortford,
United Kingdom
Bishop’s Stortford, United Kingdom

Bourgoin, France

Bourgoin, France•

Cork, Ireland

Cork, Ireland

Ferentino, Italy••

Ferentino, Italy••

Gosselies, Belgium

Gosselies, Belgium• •Groningen, Netherlands
Groningen, Netherlands••

Milton Park, United Kingdom

Milton Park, United Kingdom
Monza, Italy

Monza, Italy

•
•

•
•

•

Regensburg, Germany•

Regensburg,Rheinfelden,
Germany Germany

•
•

•
•

•

•
•
•

•

Stevenage, United Kingdom
Swindon,United Kingdom
Stevenage, United
Kingdom
Tilburg, Netherlands

Swindon, United Kingdom

Weil am Rhein, Germany

Tilburg, Netherlands

•

•

•
•

•
•
•

•
•

•

•

•

•

•
•

•
•

•

Weil am Rhein, Germany

LARGE
MOLECULEDRUG
SUBSTANCECAPABILITIES•••

Rheinfelden, Germany

SMALL
MOLECULEDRUG
SUBSTANCECAPABILITIESSpecialty
Warehousing

Specialty
Warehousing• •Moscow, Russia

Moscow, Russia

•
•

•

•

Lengnau, Switzerland
Lengnau, Switzerland

Commercial
Manufacturing

Commercial
Manufacturing•

Horsham, United
Kingdom
Horsham,United Kingdom

Linz, Austria Linz, Austria

Clinical trial
Solutions

SoftgelADVANCED
CELL ANDGENE
THERAPY
SOLUTIONSEARLY ANDLATE PHASE
DEVELOPMENTCAPABILITIESQUICK TOCARE TM
INTEGRATED
OFFERING

CLINICAL TRIAL LOGISTICS COMMERCIALOTC AND
GLOBAL SITE
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GLOBAL SITE
NETWORK
Asia

API

Biologics

Cell Therapy

Plasmids

Viral Vector

Development

Ahmedabad, India (Special Economic
Beijing, China•

Hangzhou, China•

Seoul, South Korea
Singapore (Site I)

Clinical trial
Solutions

•
•
•
•
•
•

•

Singapore (Site II)*

Commercial
Manufacturing

Specialty
Warehousing

•

•
•
•

Suzhou, China
Tokyo, JapanSMALL
MOLECULEDRUG
SUBSTANCECAPABILITIESSoftgel

LARGE
MOLECULEDRUG
SUBSTANCECAPABILITIESADVANCED
CELL ANDGENE
THERAPY
SOLUTIONSEARLY ANDLATE PHASE
DEVELOPMENTCAPABILITIESQUICK TOCARE TM
INTEGRATED
OFFERING

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GLOBAL SITE
NETWORK
Australia

API

Cell Therapy

Plasmids

Viral Vector

Development

SoftgelClinical trial
Solutions

Commercial
Manufacturing

Specialty
Warehousing•

Brisbane, Australia

SMALL
MOLECULEDRUG
SUBSTANCECAPABILITIES

Biologics

LARGE
MOLECULEDRUG
SUBSTANCECAPABILITIESADVANCED
CELL ANDGENE
THERAPY
SOLUTIONSEARLY ANDLATE PHASE
DEVELOPMENTCAPABILITIESQUICK TOCARE TM
INTEGRATED
OFFERING

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GLOBAL SITE
NETWORK
AfricaAPI

Biologics

Cell Therapy

LARGE
MOLECULEDRUG
SUBSTANCECAPABILITIESViral Vector

Development

SoftgelClinical trial
Solutions

Commercial
Manufacturing

Specialty
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Pretoria, South Africa

SMALL
MOLECULEDRUG
SUBSTANCECAPABILITIES

Plasmids

ADVANCED
CELL ANDGENE
THERAPY
SOLUTIONSEARLY ANDLATE PHASE
DEVELOPMENTCAPABILITIESQUICK TOCARE TM
INTEGRATED
OFFERING

CLINICAL TRIAL LOGISTICS COMMERCIALOTC AND
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LindaHeart transplant patient

HOW ONE BRAVE PATIENT WENT FROM THE HEART
TRANSPLANT LIST TO CLIMBING THE MOUNTAIN TRAILS.
“It felt like getting kicked in the chest by a horse.” That’s how Linda described the shock she received from her implanted
defibrillator when she had one of her yearly “mini heart attacks.” Her once active life was getting smaller and smaller as herheart continued to fail. Unable to even walk to meetings at her office without fatigue, she waited 2 ½ years on the hearttransplant list, until one day there was finally a match. But there was a twist. Linda would receive her new heart from a brave
woman who was expecting a lung and heart transplant of her own. So Linda proceeded to the hospital for one of the rarest
procedures in surgery – a domino transplant. Hours later, with the donor heart beating steadily in her chest, Linda could feela strong, healthy pulse for the first time in 15 years. At first the road to recovery would be challenging, managing over 40
doses of medications each day. But now, thanks to new, innovative drug products, she relies on just a few – many of which
are manufactured by Thermo Fisher. And a year later, she hiked to the top of Angel’s Landing in Utah, with nothing but a56
backpack, a bottle of water and healthy heart full of possibilities.
SECTION I 		SECTION II 		SECTION III

+1 919 226 3200

• thermofisher.com/patheon • pharmaservices@thermofisher.com© 2021 Thermo Fisher Scientific Inc. All rights reserved.
Published 12/21