1. Moving from product supplies
to a global solution for your processes
Christophe Grimm| Hélène Panier
June 2016

2. Agenda
• Antibody processes trends
• Suppliers implication
• A platform approach for your product life-cycle
• The Platform is greater then the sum of its parts

3. Molecules in Development
Questions:
⇒ Why re-invent the wheel for
each candidate? “Platform”
approach
⇒ Impact on processes
technologies and challenges?
⇒ Can suppliers adapt better to
support those trends?
Source: Analysis from Global Data extract August 2015
 Amongs large molecules, 75% of
pipelines in early stage:
information about trends
 Antibodies, Proteins and Vaccines
remain the largest segments
Discovery
Pre-Clinical
Phase 1
Phase 2
Phase 3
75%
Discovery & pre-clinical phase; segmentation by molecule type

4. Molecules in Development
« Antibody » segment => Diversification
Mabs remain dominant segment but other sub-categories
are emerging:
 Mabs Biosimilars is a growing segment (89% of them are
in pre-clinical/discovery)
 ADCs is a growing trend, a 11B$ market is estimated by
2025
 New Antibodies formats are emerging: bi/tri-specifics
antibodies, fragments, fusion-proteins...which could
represent up to 10% of the antibodies market in the next
10 years
Mab: discovery & preclinical candidates
Σ=2000
Source: Analysis from Global Data extract August 2015
 Does the classical Mab process apply to those new trends?
 Which innovations are required to enable those changes?
 Cost impacts and timelines to market?
Trends within the “Antibody” segment

5. Impact on Processes & Technologies
How suppliers can better support?
Source: Analysis from Global Data extract August 2015
 Flexibility
 Standardization
 “Platform/ Tool Box”
approach
to better support
 Multi-products facilities
 Tech-transfers
 Outsourcing strategies
 COGs optimization
 ...
“We want to eliminate the view of upstream and downstream.
We want ONESTREAM”
“We are looking to create a fully integrated continuous manufacturing
platform for biosimilar mAb production based in single use technologies

6. Re-defining process standards
• Specific validation
• Custom design
• Complex operations
• Automated operations
• Re-usable
Stainless Steel
• Pre-qualified components
by supplier
• Manual operations
• Supply chain management
• Consumables
Single-Use
• QbD implementation
• Pre-qualified process
steps
• Standard consumables
• Scalable (up & down)
Flexible
manufacturing

7. Equipment features approach
• Does the equipment features fit my process needs?
• How to qualify my scale down model?
• How to validate all equipment interactions?
MediaPrep Bioreaction Harvest Capture Polishing 1 Polishing 2
Virus
removal
Diafiltration
X X X X X X X
Equipment
F1
F2
F3
F5
F7
F6
F8
F4

8. Process Platform Trend
Media | Buffer Preparation
StorageMixing
Upstream Process
Seed
Bioreactor
Production
Bioreactor
FlexActFlexAct
Depth
Filtration
Micro
Filtration
Storage
Protein A
Chromatography
Post-Viral Downstream Process
Virus
Filtration
Sterile
Filtration
Filling Freezing
Sterile
Filtration
CEX
Chromatography
Low-pH
Virus
Inactivation
Storage Storage
Polishing
Membrane
Adsorption
FlexAct Storage
UF|DF
Recirculation
MixingFlexAct
Pre-Viral Downstream Process

9. Product Life-Cycle Platform approach
• How to do my process efficiently?
• How to better integrate suppliers?
PLATFORM
CLD
Media Optimization
ProcessOptimization
Scalability
Process caracterisation
Standardization
Flexibilitybydesign
Analytics
Quality by Design
Multiproduct manufacturing
PAT
ManufacturingExcellence

10.  Consistant approach for all
products/processes
 Full support & guidance through
the life cycle of your products
 Holistic view of the needs
 Standardization
 Facilitating tech transfers
 Facilitating operators trainings
 Enhance flexibility
 Better predictability
A platform is greater than the sum of its parts!
How many projects have been delayed or even stopped because the
process could not be adapted to industrial tool? Impact on cost?
1 + 1 = 3

11. 11
Distance between perception and reality is the innovator’s playground
Travis Kalanick