Drug Updates

Strengthening CDMO Supply Chain Security and Adopting Breakthrough Manufacturing Techniques

Ahead of the CPHI North America panel discussion, “Transforming the Supply Chain – Fostering Greater Resilience,” Pharmatech Associates CEO Bikash Chatterjee emphasizes the critical nature of CDMO supply chains in product resilience, a factor often undervalued by drug sponsors during partner evaluations.

As leading CDMOs operate at full capacity, drug sponsors need to prioritize risk reduction and resilience-building when partnering with smaller or mid-sized CDMOs. Chatterjee emphasizes the importance of assessing supply chains in light of increasing service demand and mounting regulatory challenges in the US.

CPHI North America 2023, scheduled for April 25-27th at the Pennsylvania Convention Centre, will unite pharmaceutical professionals from over 80 countries to address key issues like capacity limitations and supply chain optimization. Two promising technologies for bolstering 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.


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