Advancing CDMO Supply Chain Stability and Embracing State-of-the-Art Manufacturing Approaches

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In anticipation of the CPHI North America panel discussion, “Reimagining the Supply Chain – Achieving Superior Resilience,” Pharmatech Associates CEO Bikash Chatterjee highlights the essential role of CDMO supply chains in product resilience, an area frequently overlooked by drug sponsors when choosing partners.

As top-tier CDMOs reach their capacity limits, drug sponsors must shift their focus to risk minimization and resilience reinforcement when working with smaller or mid-sized CDMOs. Chatterjee urges both CDMOs and sponsors to carefully examine their supply chains in response to the rising service demand and growing regulatory hurdles in the US.

CPHI North America 2023, taking place at the Pennsylvania Convention Centre from April 25-27th, will gather pharmaceutical professionals from over 80 countries to discuss key issues such as capacity bottlenecks and supply chain refinement. Two cutting-edge technologies set to enhance supply chain resilience include continuous manufacturing and multi-tenant architectures that promote cross-party data sharing. Chatterjee highlights the impressive progress in continuous manufacturing equipment, which has become more cost-effective, user-friendly, and easier to maintain, effectively lowering entry barriers for manufacturers.

Small biotechs, opting for local CDMOs to minimize supply chain risks and ensure regulatory compliance, represent prime opportunities for adopting pharmaceutical continuous manufacturing. Chatterjee encourages pharma sponsors to thoroughly investigate the suppliers supporting their CDMO partners to detect potential supply chain weaknesses. As CDMOs also manage approval or pre-approval inspections (PAIs), launch timelines, and regulatory risks, it is essential for sponsors to incorporate proper documentation and resilience strategies into their supply chains.

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