15ViVision

OSD capabilities overview
Know what’s ahead with Thermo Fisher ScientificOral Solid Dose (OSD) solutions

Contents
Global OSD sites network			

3OSD site specializations

4Development and manufacturing services

5Integrated, value add services

7

Making your OSD right the first timeComprehensive global capabilities and resources
for OSD development and manufacturing
Global network of OSD development and manufacturing
Thermo Fisher Scientific comprehensive oral solid dose (OSD)

Our team of skilled scientists and engineers work closely withservices include phase appropriate formulation development,clients to develop tailored OSD formulations and optimized

process optimization, and scale up to commercial manufacturing.

manufacturing processes, resulting in cost-effective and highquality products delivered orally.

Pre-clinical

Phase I

Phase II

Phase III

Validation

Commercial

Bend, OR, US
Cincinnati*, OH, US
Manati, Puerto Rico, US
Whitby, Canada and Toronto, Canada
Bourgoin, France, Europe
Soft gels: High Point, NC, US and Tilburg, Netherlands, Europe
Continuous manufacturing: Greenville, NC, US* Free trade zone

3OSD site specializations
9 locations across 2 continents
Oral solid dose
Bend, Oregon, US

Cincinnati, Ohio, US

Toronto, Ontario, Canada

Clinical manufacturing

Clinical and commercial manufacturing

Clinical and commercial manufacturing•

High potency Cat 3 10 – 1 µg/m3•

Free trade zone designation•

Small-scale formulation and processdevelopment•

Cat 2 complex formulations•

High potency Cat 3 10 – 1 µg/m3
controlled substances•

Humidity control•

Solvent handling (granulation and coating)•

Wet granulation, fluid bed drying, andGerteis roller compaction•

Digital modeling•

Small-scale formulation and processdevelopment•

Gerteis roller compaction•

STYL’One compaction simulation•

Spray drying••

High potency Cat 3 10 – 1 µg/m3 and 10µg/m3 – 10 ng/m3 tablets and capsules•

High potency Cat 3 10 – 1 µg/m3 and 10µg/m3 – 10 ng/m3 wet granulation, fluid
bed drying, and Gerteis roller compaction•

Tablets, capsules, bi-layer tablets•

Coating•

CapsulesAutomated tablet and capsule inspection•

Controlled substances•

Segregated hormone manufacturing andpackaging•

Automated tablet and capsule inspection•

Serialized bottle and blister packaging
Powder in bottle
Laser printing•

Hot melt extrusion•

STYL’One compaction simulation•

Micronization•

Hot melt extrusion and spheronization•

Milling and blending••

Tablets and capsules

OROS (membrane coating and laserdrilling)•Coating•

Mini tabs and stickpack••

Packaging and labeling•

Liquid filled hard capsules••

Serialized bottle packaging•

Tablets, capsules, multiparticulates•

Non-sterile oral liquids•

Conventional extrusion

Bourgoin, France, Europe
Clinical and commercial manufacturing•

Low potency tablets•

High potency Cat 3 10 – 1 µg/m3 and 10µg/m3 – 1 ng/m3 wet granulation, fluid beddrying, and Gerteis roller compaction

Commercial manufacturing

Whitby, Ontario, Canada
Clinical and commercial manufacturing•

Low potency tablets and powders•

Bi- and tri-layer tablets•

Bottle and blister packaging•

Humidity control

SYTL’One compaction simulation (highpotency)•

High speed sachet•

Wet / dry granulation (Gerteis)•Controlled substances•

Coating•

Sachets•

Capsules•Powder in bottle•

Non-sterile oral liquids•

Non-sterile oral liquids•

Controlled substances•

Serialized packaging for all formats•

Bi-layer tableting•

Coating•

Capsules and tablets•

Serialized packaging (blisters and bottles)•

Manati, Puerto Rico, US

Clinical and commercial manufacturing•

Free trade zone designation•

Soflet® gelatin enrobed tablet•

Highly potent compounds••

Sofgels®

Versatrol® controlled releasetechnology•

Chewels®

••

Soft lozenges

Entericare ® delayed releasetechnology•

Hormones•

Twist-offs•

Controlled substances•

In-line and off-line printing

Medium to large scale commercialmanufacturing (low potency)•

Free trade zone designation•

Controlled substances (DEA schedule 2to 5)•Wet granulation, including solvent•High shear mixing spherical beads•

Tablets within a tablet•Capsules•

Powders in bottle•

Coating (aqueous and solvent)•Tablet printing•

Serialized bottle packaging

OSD continuous manufacturing

Soft gels
High Point, North Carolina, US
Tilburg, Netherlands, Europe•

Greenville, North Carolina, US•••

Continuous tablet and capsulemanufacturing•

Roller compaction (Gerteis)•

Direct blend and compression

Low potency and high potency
Cat 3 10 – 1 µg/m3•

Tablets•

CapsulesControlled substances4Manufacturing and development services
Phase appropriate activities and support from pre-clinicaldevelopment to commercial manufacturing
Formulation development activities

Pre-clinical

Phase I

Phase II

Drug substance characterization:

Phase I IND / IMPD enabling studies:

Dosage form development:•Salt and polymorph screening••

Formulation feasibility studies•

Forced degradation

Cleaning method development andvalidation•

Candidate selection•

Phase appropriate dose form
development

DP dosage form appropriate method
modification and validation

IND / IMPD enabling studies:••

Development of DP scalable
formulation

Solubility in water, buffer, solvent, lipidsolvent

Early phase formulation method
development / validation••Formulation potency evaluation•

Stability in aqueous and lipid solvents•

Early phase stability studies

Process suitability for mid/late phase
activity assessment / modificationand validation•

Solubility enhancement technology
modeling•

FIH CTM activities•

CTM stability

•

•

•

Physico-chemical characterization

Phase II CTM:•

CTM manufacturing

Bridging studies:•CTM stability•

Formulation switch assessment

Scale up consideration:•

Comparative dissolution studies•

Formulation scale up activities•

Manufacturing process assessment

Validation

Phase IIICommercial

Phase III registration activities:

Scale up to validation:

Post commercial activities:•

Three (3) lots of each dose
registration batch•

Manufacturing process confirmation•

Continuous process verification (CPV)•

Packaging confirmation•

SUPAC post approval support•

Packaging studies in each SKU•

Supply chain risk assessment•

Secondary supply and manufacturing•

Late phase clinical supplymanufacturing

PPQ / validation batch manufacture:•

Life cycle management•

Alternative API supplier qualification•

Regulatory CMC support forsubmission dossier•

Supply chain commercialconsiderations•

TT late phase to commercial planning•

DOE optimization•

QbD studies•PPQ•

Validation stability batch

Learn more5

Manufacturing capabilities
A broad range of manufacturing capabilities tomeet your molecules unique needs
Manufacturing solutions from simple to complex forms
From simple to complex, access to a wide range of conventional

your molecule’s unique properties. We will work with you toand specialized dosage form manufacturing solutions can create

ensure that speed and efficiency are built in to accelerate youran integrated drug formulation program that is customized tomolecule’s journey to first-in-human (FIH) studies.

Manufacturing capabilities
Compound types• Low to highly potent(up to Cat 3 10 µg/m3– 10 ng/m3)• Cytostatics• Hormones• Controlled /scheduledsubstances• Sensitizers and otherpotent compounds

Dosage forms

Batch sizes

Processes• Tablets• Immediate release• 0.5 - 2 kg

• Direct blending• Capsules• Enteric release• 2 - 10 kg• Granules / powders
in bottles, capsules,
stickpacks, sachets• Zero-order release• 10 - 100 kg• Dry granulation(roller compaction)• Enteric + controlledrelease• 100 - 2,000 kg+• Softgels / liquid
filled hard shells• Colonic release• Non-sterile oral
liquids (solutionsand suspensions)• Non-sterile liquid
nasal sprays*Formulations• Combinations ofthe above releaseprofiles• Pediatric dosage
forms• High shear wet
granulation• Fluid bed
granulation• Film polymer
coating• Other• Fix-dose
combinations

All manufacturing batches include analytical services including method development / validation, testing and release, stability services, and QP release.

Continuous manufacturing• Modular design

Commercial manufacturing analytical solutions• Direct blending• Up to high potency Cat 3
10 – 1 µg/m3• In-process control
production support• Stability testing for various
ICH climatic zones• Dry granulation• Line I (15 kg - 50 kg/hr)• Release testing• NDA / ANDA dossier
support• Wet granulation• PAR studies

Learn more
6

Integrated, value add services
End-to-end support ensures you have theresources and expertise needed for success
Simplicity, speed, and scalability
Fully integrated, value add services across the clinical

Streamlined project governance, paperwork, and integrated

development and manufacturing spectrum ensure you havetimelines across service offerings ensure simplicity is built into

access to resources and expertise needed for success. For

the development process.

OSD development and manufacturing, integrated regulatory
support, commercial packaging, clinical trial support, and totaltransportation management save time and mitigate risk.

Improved information access across development andmanufacturing services enable speed to meet aggressive
timelines and proactively mitigate risk.
Global networks with regional expertise ensure scalability as
the program progresses, leveraging the full suite of services fromearly development through commercialization.

Regulatory support - Regulatory support andconsulting for major jurisdictions during dossier
review, prreview, andpre-licensure meetings and inspections

Regulatory
supportTotaltransportation
management

Commercial
packaging

Clinical trial
supportCommercial packaging - Reliable service levels
and a focus on quality for both small and large
volume commercial packaging

Clinical trial support - Integrated clinical trial
services including packaging, labeling, supply
chain optimization, distribution and logistics, andancillary management

Total transportation management - Optimized
transport routes and data-driven transporation
mode selection provide better resource utilization and reduce risk

7Know what’s ahead with OSD solutions
Flexible OSD solutions backed by a global network ofexpertise to address your small and large molecule’s
unique needs
Drug development services

Manufacturing services

The power of one global network

Streamline development with unmatched

A high-tech approach to project visibility

Global network of experts available forreliability and tailored expertise.

to ensure quality and reliability.

your OSD needs during the entire lifecycle

Developed42%

129of FDA approved
non-sterile small
molecules in2023

400+Projects progressed
to next stage during
last 5 years

NDA approvals since 2011255+
Tech transfer andtech transfer-likeprojects per year

Contact us to learn more
+1 919 226 3200 • thermofisher.com/patheon • pharmaservices@thermofisher.com© 2024 Thermo Fisher Scientific Inc. All rights reserved.
Published 08/20248