Addressing Supply Chain Vulnerabilities and Embracing Innovation for US CDMOs

Pharmatech Associates CEO Bikash Chatterjee, ahead of CPHI North America’s panel on “Reinventing the Supply Chain – The Journey Towards Enhanced Resilience,” stresses the importance of CDMO supply chains in maintaining product resilience, an area often neglected by drug sponsors when choosing partners.

As leading CDMOs reach capacity limits, drug sponsors must concentrate on risk reduction and resilience enhancement when collaborating with small or mid-sized CDMOs. Chatterjee advises that increasing service demands and regulatory obligations in the US require both CDMOs and sponsors to closely examine their supply chains to avert future challenges.

CPHI North America 2023, scheduled for April 25-27th at the Pennsylvania Convention Centre, will host pharmaceutical professionals from over 80 countries to discuss pressing issues like capacity constraints and supply chain management. Two key technologies for bolstering supply chain resilience are continuous manufacturing and multi-tenant architectures facilitating cross-party data sharing. Chatterjee points out the remarkable progress in continuous manufacturing equipment, which is now more affordable, user-friendly, and easier to maintain, thus reducing entry barriers for manufacturers.

Smaller biotechs, who rely on local CDMOs as regulatory safeguards and choose them for decreased supply chain risks, present significant opportunities for implementing pharmaceutical continuous manufacturing. Chatterjee recommends pharma sponsors delve deeper into the suppliers behind their CDMO partners to identify potential supply chain threats. With CDMOs also responsible for approval or pre-approval inspections (PAIs), as well as launch timelines and regulatory risks, it is crucial for sponsors to embed proper documentation and resilience measures into their supply chains.

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