SMALL
MOLECULE
API SOLUTIONSTAKING A BIG PICTURE APPROACH

Pete and Lisa Beerse

HOW A COMBINATION OF MEDICINES HELPED ONE
MAN TAKE BACK HIS LIFE, AND INSPIRE US ALL.
On a quiet Sunday afternoon, Pete and his wife Lisa took a moment to sit on a porch swing and relax. A small piece of wood
holding the chain broke and they fell backwards causing Pete to break his neck. Now, this father of eight who had been acollege athlete had to face life in a wheelchair, requiring assistance for even his most basic needs. Pete says while thephysical toll was tremendous, the emotional and mental toll was even worse. In addition to dealing with his body having tounderstand its lack of function – from mobility to heat regulation – there was the depression and anxiety that also comes withwatching his wife and kids step in to care for him. But Pete and Lisa did not give up. They worked for over a year with doctors
to find the right mix of medications. Though it was a grueling process, eventually they got it right. Pete credits thesemedications with saving his life and giving him the strength to persevere. Together, Pete and Lisa look forward to thefuture: their daughter’s wedding, time with friends and family, even their first trip on an airplane since the accident. As Pete
2says, “We’ve been married 32 years. Not long enough.”Fifty-eight percent of medicines in development are small molecules—
many of which feature highly potent molecules.
Additionally, 70% of drugs in development have solubility issues, requiring special attention to formulation. With competitiveoptions for API outsourcing in all geographical regions, it can be difficult to choose the right partner for your project,regardless of its complexity. Thermo Fisher Scientific offers the expertise and capabilities to partner with pharmaceuticalcompanies of all sizes and in all stages of development.

3Making your API rightthe first time:
From grams to tonnes

GLOBAL NETWORK AND UNMATCHEDSCIENTIFIC EXPERTISE

Time is indispensable and quality is critical when it comesto the development and manufacture of your small moleculeAPI. Getting to your next milestone doesn’t have to be ajourney you navigate alone. Thermo Fisher Scientific Pharma
Services offers a full range of scientific and regulatory
services to help get you to clinic quickly and find yourrunway to commercial.
Take advantage of the expertise of our world-class chemists
and our global network of development and manufacturing
facilities. We offer a broad range of chemistries and ourability to integrate drug substance and drug productdevelopment with clinical services gives you the ability toscale your project under one roof.

We support API development at six sites within the UnitedStates and Europe—two locations in Florence, South Carolina,
and one site each in Greenville, South Carolina; Cork, Ireland;Linz, Austria, and Regensburg, Germany. Within our network,
we have more than 370 PhD and Masters degrees dedicatedto refining, optimizing, and launching your API project.
We have over 50 years of manufacturing experience forsmall molecule API and offer key capabilities from preclinicalto commercial.

“High quality facility, management,and technical team.”— Clinical-stage biopharmaceutical company, USA“Outstanding technical ability, strong communication and team leadership.”— Small molecule biotechnology company, USA

API drug substance sites

Cork, Ireland
Regensburg,Germany
Greenville,
South Carolina

Linz, Austria

Florence,
South Carolina (x2)4

OUR SOLUTIONS
From early process optimization work all the way to commercialscale development, we provide key services across all phasesof development to get your project to market:• Route scouting• Solid-state chemistry• Process development:
Work directly with scientists with deep chemistryknowledge and many years of experience insuccessfully supporting early and later phaseclinical development programs. Our experts offer
you cutting edge technology from start to finish in
multi-step chemical synthesis and from traditional
to complex manufacturing.
• Clinical supply manufacturing• Tech transfer and scale-up of new andexisting processes• Continuous improvement of existing processes• Expertise with difficult-to-manufacture APIs
• Innovative solutions to manufacture yourcomplex API• High potency compounds andcontrolled substances• Comprehensive analytical services:
To support route scouting and process development
activities and accelerate your clinical programs,
we provide a comprehensive range of analyticalservices. Our analytical development and quality
control teams have in-house access to acomprehensive range of state-of-the-art analyticaltechniques and extensive experience• Commercial supply manufacturing• Supply chain management• Spray drying:
Address bioavailability challenges with ourspray drying expertise and technologies, withsolutions from preclinical to commercial scale.
Move to your next milestone efficiently by scaling
through our integrated drug substance and drug
product network.
• Micronization• Physical characterization“Very reliable, sound expertise, excellent scientific input.”— Clinical-stage biopharmaceutical company, Germany

5Early development: Achieve molecule milestones fasterwith Patheon™ Quick to Clinic™ small molecule
Our goal at Thermo Fisher is to always innovate and expand
our offerings in order to enable our clients to reach theirgoals. This innovation includes our newly enhanced Quickto Clinic™ program for oral solids. This service offers expert
API and drug product manufacture, as well as clinicalservices, supported by phase-appropriate formulation andessential solid-state work to allow clients to quickly reach
their Phase I milestones. The integrated approach allows
you to save time, simplify your supply chain, and makeinvestments for future milestones. Our unmatched expertise
allows clients in early development to reduce their risk as
they move into clinic.

Evolution of the Quick to Clinic™ offering

2009

2018

2020

Focus on rapid Phase I
formulation and clinicalmaterial supply

Enhanced with the additionof clinical labeling andpackaging services

Further enhancements tointegrate API manufacturing, drug
product clinical supply & essential
solid-state chemistry services

6

Harness the power of an integrated network with
Quick to Care™
Patheon’s Quick to Care™ suite of services delivers astreamlined drug development program. This offering
combines your drug substance and drug productdevelopment, clinical manufacturing, forecasting, demandplanning, and clinical trial supply execution into a single
solution to accelerate your discovery to proof of concept.
Save time and money on your development journey with:• Comprehensive program management with asingle point of contact• Scientific insight to speed every step
• Assurance of supply• Simplified contract and administration109
new drug
applications in thelast decade(2X the nearest
competitor)

95%
averageright-first-timerate in 2021

50+
years of experience
manufacturingcGMP API~275
small molecules
worked on in 2021

• Optimized tech transfers

Clinical supply planning
Viral vector development& manufacturing
Drug substance development& manufacturing
Drug product development& manufacturing

Patient-centricfocus

Clinical trial packaging& labeling
Clinical material distribution& logistics
Transportation management
Commercial manufacturing& packaging

7

When you’re ready for the next step in drug development,
our drug product and clinical services experts can help withformulation, packaging, labelling, distribution, and more.
Drug product development
Every step of the drug development process brings
unique challenges and opportunities. We have designed arange of flexible solutions to meet your molecule’s uniqueneeds across formulation development, analytical method
development, bioavailability enhancement, manufacturing
process development and clinical batch manufacturing.
Clinical supply services

Runway to commercial: Scale with a trusted partner
Thermo Fisher Scientific offers commercial API manufacturing
under full cGMP conditions with speed, efficiency, andexceptional quality. We bring flexibility to adapt to changes
in your market and mission and will never stop working tooptimize your process to increase outputs while reducing
timelines. As your trusted partner, we are committed toproviding you with:• Global capacity

Once your product is ready for clinical trials, we can assist
with the logistics. Whether you need primary or secondary
packaging of your clinical drug, storage, distribution,
logistics, cold chain management, or comparator andancillary sourcing, our global team can meet the needs ofevery trial regardless of size, phase or therapeutic area.
We also offer import/export services, including Importer ofRecord (IOR) capability in more than 25 countries to date,and best-in-class direct-to-patient services.
We are committed to delivering the highest possible value
while ensuring adherence to the highest level of quality,performance, reliability and sustainability standards.

• Technical expertise• High containment and regulatory compliance• Continuous innovation• Commitment to quality• Spotless reputation

Learn more about our extensive API development and manufacturing offerings.
Contact us today.

8

+1 919 226 3200

• thermofisher.com/patheon • pharmaservices@thermofisher.com© 2022 Thermo Fisher Scientific Inc. All rights reserved.
Published 04/2022