In anticipation of the CPHI North America panel discussion, “Rethinking the Supply Chain – Towards Heightened Resilience,” Pharmatech Associates CEO Bikash Chatterjee emphasizes the critical role of CDMO supply chains in product resilience, an area frequently undervalued by drug sponsors during partner selection.

As leading CDMOs reach their capacity limits, drug sponsors must concentrate on risk reduction and resilience enhancement when collaborating with small or mid-sized CDMOs. Chatterjee advises that increasing service demands and regulatory obligations in the US require both CDMOs and sponsors to closely examine their supply chains to avert future challenges.

CPHI North America 2023, scheduled for April 25-27th at the Pennsylvania Convention Centre, will provide a platform for pharmaceutical professionals from over 80 countries to discuss pressing issues like capacity constraints and supply chain management. Two key technologies for bolstering supply chain resilience are continuous manufacturing and multi-tenant architectures facilitating cross-party data sharing. Chatterjee points out the remarkable progress in continuous manufacturing equipment, which is now more affordable, user-friendly, and easier to maintain, thus reducing 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.