CDMO Supply Chain Risks and the Promise of Continuous Manufacturing in US Pharma Industry

As the CPHI North America conference approaches, featuring a panel on “Redesigning the Supply Chain – The Path to Greater Resilience,” Pharmatech Associates CEO Bikash Chatterjee emphasizes the critical role of CDMO supply chains in product resilience. Despite this, drug sponsors frequently neglect this aspect when selecting partners.

With top-tier CDMOs operating at full capacity, drug sponsors must prioritize risk mitigation and resilience-building when working with smaller or mid-sized CDMOs. Chatterjee believes that as demand for services and regulatory pressures grow in the US, both CDMOs and sponsors should examine their supply chains to preempt future risks.

Taking place at the Pennsylvania Convention Centre from April 25-27th, CPHI North America 2023 will gather pharmaceutical professionals from over 80 countries for networking and conference sessions addressing capacity and supply chain concerns. Two promising technologies to improve supply chain resilience include continuous manufacturing and multi-tenant architectures for cross-party data sharing. Chatterjee highlights the significant advancements in continuous manufacturing equipment, now more cost-effective, easier to clean, and maintain, ultimately lowering barriers to entry.

Chatterjee identifies smaller biotechs, relying on local CDMOs for reduced supply chain risk, as prime candidates for adopting pharmaceutical continuous manufacturing. He advises pharma sponsors to scrutinize the suppliers of their CDMO partners to uncover potential supply chain vulnerabilities. As CDMOs also handle approval or pre-approval inspections (PAIs), launch timelines, and regulatory risks, sponsors must ensure proper documentation and resilience are integrated into their supply chains.

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