BIOPHARMACAPABILITIESOVERVIEW

1

Table of contents

203

Who are we04

The value we bring06

How we deliver12

Our process

3

The value we bring
We help our customers accelerate innovationand enhance productivity, underpinned by quality

We take pridein our Mission

We enable our customers
to make the world healthier,cleaner and safer

4

R&D
outsourcing

Technology
based
partnership

Supply chain
management

Digital sciencecapabilities
Companion
diagnostics
development

Production
optimization

ClientLaboratory
flow andefficiency

Clinical trial &manufacturingservices

Exclusive
tools andapplications

Complianceto defined
standards

Outsourced
enterpriseservices

Assuranceof supply
quality andresilience5How we deliver
World-Class Capabilities

Workflow Solutions

Productivity Solutions

Foundation of Quality

Leading product and service

Integrated technologies thatdrive better outcomes

Optimized operational capabilities

Commitment to excellence• Transactional excellence• Robust quality systems• Lab informatics• Assurance of supply• Supply chain optimization• Adapting to a dynamic regulatory landscape• Process control and monitoring• Strong regulatory track record• Best-in-class instruments, consumables
and equipment• Target identification• Program-based outsourcing services for drug
substance and drug product and clinical trials• Spans the breadth of life sciences• Biomarker-based companion diagnostics• Precision medicine• Process analytical technologies

Accelerating Innovation

6• Clinical trial supply and management

Enhancing Productivity

Uncompromising Quality

7

World-class capabilities

Comprehensive in-house or outsourcing
solutions from molecule to medicine
Early Discoveryand Research

Process Development

Clinical Trials

CommercialProduction

Solutions to create
or source newtherapeutic molecules

Solutions to create or source new therapeutic molecules

Support across all phases of clinical development

Production continuity
from clinical trials tocommercial scale

Discovery research

Process development and optimization

Clinical trials
manufacturing

Clinical trial supplyand logistics

Commercial launch• World-class detection, sample
throughput and specificity• Target identification• Scale-up solutions• Clinical supply optimization• Consumables, reagents,
lab equipment• Cell culture customization• Technology transfer• Molecule and application-specificprocesses• Process monitoring• Manufacturing of clinical trial
material (biologics andsmall molecules)• Analytical technologies• Drug design, including complex
formulation and delivery format• Analytical instrumentation• Lab productivity tools• Global distribution andsupply chain management$1B

R&D Investment

8• Drug substance and drug productdevelopment for small and large
molecules• Materials characterization• Process validation>5,000 R&D Scientists and Engineers• Bioprocessing solutions forin-house manufacturing• Compliance management• Technology transfer• Primary & secondary packaging• Biologics andsmall molecule manufacturing• Quality control and assuranceequipment• Label design, translation & 		• Process analytical testingproduction
solutions• Storage & distribution• Process monitoring• Global network• Comparator & Ancillary materials
sourcing & management

Supported the development of250 small & large molecules in last 3 years• Validation and regulatory
support packages
More than 1,000 molecules
developed 40+ dosage forms

9Integrated workflows

Innovation investments put us at
the forefront of scientific advances
Precision
Medicine

Structural Biology/Protein Analysis

Biopharma
QA/QC

Broadest combination ofcapabilities across the precision
medicine workflow: Genetic andprotein analysis, biobanking,informatics and diagnostics

Leading cryo-electron microscopy
and high-resolution mass
spectrometry workflow solutions

Omics-based analyticaltechnologies for quality testing
and release

Productivity solutions
to meet your unique needs
Enhanced
Procurement
Processes• Simplified access to a broad portfolio of leading brands

Supply Chain
Simplification• Purpose-built and integrated supply chain		• cGMP supply chain distribution centers		
• Specialized supply management (e.g. biorepository and cold chain storage)• Leading eBusiness platform and electronic transaction options• Supplier aggregation and tail spend management• Customer and technical support• Assurance of supply		• Safety stock programs		
• Secondary sourcing• Supply and order management services• Material handling and logistics• Lab supplies inventory management

DigitallyEnabled• Cloud-connected instruments• Remote monitoring and diagnostics for instruments and equipment• Algorithm-based predictive instrument maintenance• Manufacturing execution system (MES) to integrate unit operations on one network• Scientific apps
• Data and information management

2.5M

products from
9,000 suppliers

10>70%

eCommerce transactions>1,000on-site resources>4,500

instrument
servicing FTEs

11

Foundation of quality

ProductsCustomer
Satisfaction

Our process• Rigorous quality management system(QMS) that meets the demands placedon our customers

Processes• Practical Process Improvement (PPI)
business system and lean practices• Manufacturing redundancy and business
continuity strategies to assure supply>20

Approvals from regulatory
authorities for Pharma Services
sites globally>1,000

Molecules developedin the last decade107

New drug applicationsin the last decade(2X the nearest competitor)

Example: Pharma Services (CDMO) business1213

Expanding our end-to-end pharmaceutical services offering

Built on a foundation of quality systems
and commitment to continuous improvement,
we help you achieve success at every milestone
Create or source
your ingredient

Design theideal formulation

Scale to yournext milestone

Develop clinicalsupply chain strategy

Accelerateclinical research

Deliver a successfulcommercial launch• Large and Small Molecule
API Development• Quick to Clinic®

• Pre-clinical• Clinical Supply Optimization• +95% Right First Time delivery• Complex Formulations• Early Phase Development• Route Scouting• Solubility Enhancement• Clinical Trial Material Manufacture• Compliance Management
and Risk Mitigation• Primary and SecondaryPackaging• Labeling Design & Production• Oral Solid Dose

• Cell Line Development• Analytical Methods• Late Phase Trials• Analytical Methods• Process Development• Commercialization• Process Development• Oral Solid and Sterile Development

14• Label Translation and Planning• Global Network• Ancillary Materials Sourcing• Cold Chain Material Management• Sterile Injectable• Softgels• Flexible Business Models• cGMP Biologics Storage / 		Biorepository• Viral Vector Development
and Manufacturing

185 technology transfers in 2017:• Storage and Distribution• Logistics and Transportation• Commercial Manufacturing

44 Drug substance, 3 Development, 138 Commercial• Comparator Sourcing• 75% of all dosage forms• Pharmacy Services

11,000+unique clinical packaging lots in 2017

More than 500,000
clinical shipments completed in 2018

107

NDAs 2009 - 201815

70,000

5,000

employees

R&D
scientists/
engineers

$1B

$24B

invested in R&D+1 919 226 3200 � thermofisher.com/patheon � pharmaservices@thermofisher.com© 2019 Thermo Fisher Scientific Inc. All rights reserved.

in revenues