With the CPHI North America panel discussion, “Restructuring the Supply Chain – Pursuing Enhanced Resilience,” on the horizon, Pharmatech Associates CEO Bikash Chatterjee emphasizes the critical nature of CDMO supply chains in product resilience, an aspect frequently neglected by drug sponsors during partner selection.
As leading CDMOs reach their capacity, drug sponsors must concentrate on risk mitigation and resilience development when partnering with smaller or mid-sized CDMOs. Chatterjee advises that in light of escalating service demands and increasing 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, scheduled for April 25-27th at the Pennsylvania Convention Centre, will provide a platform for pharmaceutical professionals from over 80 countries to address pressing issues such as capacity constraints and supply chain improvements. Two innovative technologies poised to bolster supply chain resilience include continuous manufacturing and multi-tenant architectures that enable cross-party data sharing. Chatterjee points to the remarkable advancements in continuous manufacturing equipment, which has become more affordable, efficient, and easier to maintain, consequently reducing barriers to entry for manufacturers.
Smaller biotechs, who rely on local CDMOs for regulatory adherence and diminished supply chain risks, present significant opportunities for adopting pharmaceutical continuous manufacturing. Chatterjee suggests that pharma sponsors conduct a thorough investigation into the suppliers backing their CDMO partners to uncover potential supply chain threats. As CDMOs are also responsible for approval or pre-approval inspections (PAIs), launch timelines, and regulatory risks, it is crucial for sponsors to embed proper documentation and resilience measures into their supply chains.