The document discusses long term manufacturing strategies for biopharmaceutical companies. It notes shifts in the manufacturing paradigm due to legacy facilities, evolving technologies, and portfolio growth. External factors like regulations, competition, and pricing also impact strategies. Options discussed include using internal manufacturing by expanding existing facilities or building new ones, versus external manufacturing by partnering with contract manufacturing organizations. The best approach requires understanding current and future product needs, guidelines on internal vs. external manufacturing, and comprehensive evaluation of capacity, costs, risks and other factors for different strategic options.

1. Biopharmaceutical Manufacturing Excellence:
Long Term Manufacturing Strategies
Rémy Dumortier, PhD, MBA
Soligenix , Princeton, NJ, USA
2016
BioInnova-on
Leaders
Summit
February
10th
-­‐11th,
2016
Berlin,
Germany

2. Disclaimer
The opinions expressed in this presentation and on the following slides
are solely those of the presenter and not necessarily those of Soligenix.
Soligenix does not guarantee the accuracy or reliability of the
information provided herein.

4. Biologics Manufacturing Paradigm
Shift: Internal Factors
• Legacy facilities.
• Technology platform diversification.
• Evolution of manufacturing technologies.
• Increase in the product portfolio.

5. Biologics Manufacturing Paradigm Shift:
External Factors
• Local manufacturing requirements.
• Competition.
• Business Alliances.
• Pricing pressure.

6. Manufacturing for Now and Future
• Sufficient capacity
• Flexibility for low and large volume products
• Low(er) manufacturing cost
• Flexibility to support various markets
• Meeting regulatory agencies expectations (PAT,
Continuous manufacturing, etc.)

7. What should we do about our
manufacturing network?

8. Options
• Internal vs. External manufacturing
! Greenfield vs. Brownfield vs. Existing Facility
! CMO vs. Strategic Partnership

9. Comparison of Options
Internal Manufacturing
• Large capital cost for
initial investment and life
cycle management.
• Out dated facility.
• Schedule flexibility.
• Full access to the data.
• Flexibility for custom
designed technology.
External Manufacturing
• Discrete batch expenses.
• Flexibility for the exit.
• Upfront commitment on
the # of batches/
campaigns.
• Limited access to the
data.
• Flexibility for common
technology products.

10. Comparison of Options
New Facility
• Designed for Purpose.
• Freedom for innovation.
• Long lead time.
• Extremely expensive
option unless product
portfolio warrants full
capacity.
Existing Facility
• Limited options.
• Regulatory filing impact.
• (Relatively) shorter lead
time.
• Suitable for small volume
and/or clinical products.

11. Demand
Supply

12. Demand
Supply
Supply
Shortage

13. Options
(1) Find another CMO to add more capacity.
(2) Expand Site A and B while leveraging
CMO(s) for the remaining capacity gap
(3) Build a new facility to bring the products in-
house.
(4) Partner with CMOs for a new facility.
Calculate
NPV
on
each
op-ons

14. Other factors to consider
• Technical capabilities: Resources gap
• Company strategy on “manufacturing”: internal
versus external
• The level of ‘Risk’ that can be tolerated

15. In Closing
• Building a long term manufacturing strategy
requires:
– Understanding of the product portfolio
landscape: Current vs. future.
– High level strategic guideline on
manufacturing: Internal vs. External.
– Comprehensive evaluation of different options
before decision.