In anticipation of the CPHI North America panel, “Reinventing the Supply Chain – A Blueprint for Enhanced Resilience,” Pharmatech Associates CEO Bikash Chatterjee highlights the crucial role CDMO supply chains play in product resilience, an area frequently undervalued by drug sponsors during partner selection.
With major CDMOs reaching their capacity, drug sponsors need to concentrate on risk management and building resilience when collaborating with smaller or mid-sized CDMOs. Chatterjee emphasizes the importance of evaluating supply chains in the face of increasing service demand and growing regulatory challenges in the US.
Scheduled for April 25-27th at the Pennsylvania Convention Centre, CPHI North America 2023 will provide a platform for pharmaceutical professionals from over 80 countries to address capacity issues and supply chain solutions. Two pivotal technologies for enhancing supply chain resilience include continuous manufacturing and multi-tenant architectures that enable cross-party data sharing. Chatterjee underscores the significant improvements in continuous manufacturing equipment, now more cost-effective, user-friendly, and easier to maintain, effectively lowering entry barriers.
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.