In the lead-up to the CPHI North America panel discussion, “Revitalizing the Supply Chain – Building Greater Resilience,” Pharmatech Associates CEO Bikash Chatterjee highlights the vital role of CDMO supply chains in product resilience, a factor often underestimated by drug sponsors during partner evaluations.
As major CDMOs operate at full capacity, drug sponsors need to prioritize risk management and resilience-building when collaborating with smaller or mid-sized CDMOs. Chatterjee emphasizes the importance of assessing supply chains in the face of growing service demand and mounting regulatory challenges in the US.
CPHI North America 2023, taking place at the Pennsylvania Convention Centre from April 25-27th, will unite pharmaceutical professionals from over 80 countries to address key issues like capacity limitations and supply chain enhancements. Two promising technologies for augmenting supply chain resilience are continuous manufacturing and multi-tenant architectures that facilitate cross-party data sharing. Chatterjee underscores the significant advancements in continuous manufacturing equipment, which is now more cost-effective, user-friendly, and easier to maintain, effectively lowering entry barriers.
Emerging biotechs, who rely on local CDMOs for regulatory compliance and reduced supply chain risks, offer significant potential for implementing pharmaceutical continuous manufacturing. Chatterjee recommends that pharma sponsors delve deeper into the suppliers behind their CDMO partners to identify possible supply chain vulnerabilities. As CDMOs also handle approval or pre-approval inspections (PAIs), launch timelines, and regulatory risks, it is vital for sponsors to ensure appropriate documentation and resilience measures are integrated into their supply chains.