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      

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.

Biologics Manufacturing Paradigm Shift: Internal Factors

•  Legacy facilities.

•  Technology platform diversification.

•  Evolution of manufacturing technologies.

•  Increase in the product portfolio.

Biologics Manufacturing Paradigm Shift: External Factors

•  Local manufacturing requirements.

•  Competition.

•  Business Alliances.

•  Pricing pressure.

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.)

What should we do about our manufacturing network?

Options

•  Internal vs. External manufacturing

! Greenfield vs. Brownfield vs. Existing Facility

! CMO vs. Strategic Partnership

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.

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.

Demand   Supply  

Demand   Supply  

Supply  Shortage  

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  

Other factors to consider

•  Technical capabilities: Resources gap

•  Company strategy on “manufacturing”: internal versus external

•  The level of ‘Risk’ that can be tolerated

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.