Is a Geographically Integrated CMC Supply Chain the Next Evolution of the CDMO Model | CPhI North America

 

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Is a Geographically Integrated CMC Supply Chain the Next Evolution of the CDMO Model

Jingling Che, Ph.D. (Vic President Pharmaceutical Development Services, STA Pharmaceutical, a WuXi App Tec Company)

Xiaoyong Fu, Ph.D. (Senior Vice President API Development & Commercialization, STA Pharmaceutical, a WuXi App Tec Company)

Location: E353b

Date: Wednesday, May 1

Time: 11:45am - 12:30pm

Track: Drug Development

Vault Recording: TBD

Time to market is critical not just for helping bring vital medicines to patients faster, but also for enabling biotechs to reach the revenue generating stage. In fact, for many biotechs the ability to reach clinical milestones quicker is an essential factor in achieving payments and/or gaining access to further funding rounds.
With increased internationalization across the industry, one newer approach to help speed development programs is to choose an integrated CDMO which can undertake both API and drug product work and do so at manufacturing sites which are within a close geographic proximity. Partnering with a CDMO with synchronized facilities in close proximity can help move NCEs through the development pipeline faster by simplifying and synergizing planning, and through increased knowledge retention, material sharing, and quality systems.

5 Takeaways:
• Close proximity of integrated facilities and team members is important in helping shorten the overall time to market
• Time and cost benefits through knowledge retention and material sharing – as well as in tech transfer in latter stages
• State-of-the art facilities that share a single quality system at every stage ensure optimal solution in record time from small quantities of starting material to commercial
• A dedicated product manager can guide compounds from stage to stage more efficiently with ‘in person’ meetings on-site. For example, if a process chemist or a formulation scientist is needed at the manufacturing plant, this can be arranged in a matter of minutes.
• WuXi STA has built a whole industrial supply chain that runs through chemical and formulation innovations from APIs to drug products, and has built a series of platforms including early clinical, late clinical, and commercial material movement.
o The benefit of this is the creation of a more seamless and enabling process. For example, if there are delays in API production, they don’t have consequential effects for drug product manufacturing, as the drug product team can readily secure a new slot when the API is ready.