Navigating CDMO Supply Chain Challenges and Adopting Cutting-Edge Manufacturing Technologies
As the CPHI North America panel discussion on “Revamping the Supply Chain – Paving the Way for Greater Resilience” approaches, Pharmatech Associates CEO Bikash Chatterjee underscores the critical nature of CDMO supply chains in product resilience, a factor often underestimated by drug sponsors during partner evaluations.
When collaborating with small or mid-sized CDMOs, drug sponsors must prioritize risk alleviation and resilience-building, as leading CDMOs are already operating at full capacity. Chatterjee advises that in light of escalating service demands and mounting regulatory pressures in the US, it is crucial for both CDMOs and sponsors to scrutinize their supply chains to prevent future obstacles.
CPHI North America 2023, taking place at the Pennsylvania Convention Centre from April 25-27th, will unite pharmaceutical professionals from over 80 countries to discuss capacity limitations and supply chain improvements. Two promising technologies for augmenting supply chain resilience are continuous manufacturing and multi-tenant architectures that facilitate cross-party data sharing. Chatterjee emphasizes the substantial advancements in continuous manufacturing equipment, which is now more affordable, efficient, and easier to maintain, consequently reducing barriers to entry.
Emerging biotechs, who rely on local CDMOs for regulatory compliance and diminished supply chain risks, offer significant potential for implementing pharmaceutical continuous manufacturing. Chatterjee recommends that pharma sponsors thoroughly examine the suppliers behind their CDMO partners to identify any possible supply chain vulnerabilities. With CDMOs handling 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.