Addressing CDMO Supply Chain Vulnerabilities and Leveraging Advanced Manufacturing Techniques
Prior to the CPHI North America panel on “Transforming the Supply Chain – The Path Towards Improved Resilience,” Pharmatech Associates CEO Bikash Chatterjee stresses the importance of CDMO supply chains in maintaining product resilience. However, this aspect is often overlooked by drug sponsors when selecting partners.
As top CDMOs operate at maximum capacity, drug sponsors need to focus on mitigating risks and fostering resilience when partnering with smaller or mid-sized CDMOs. Chatterjee highlights the need for both CDMOs and sponsors to carefully evaluate their supply chains, given the rising demand for services and increasing regulatory constraints in the US.
CPHI North America 2023, set to take place at the Pennsylvania Convention Centre from April 25-27th, will host pharmaceutical professionals from more than 80 countries to address pressing issues such as capacity bottlenecks and supply chain optimization. Two innovative technologies poised to bolster supply chain resilience include continuous manufacturing and multi-tenant architectures that promote cross-party data sharing. Chatterjee points to the remarkable advancements in continuous manufacturing equipment, which has become more cost-effective, user-friendly, and easier to maintain, effectively lowering entry barriers for manufacturers.
Smaller biotechs, who rely on local CDMOs to minimize supply chain risks and ensure regulatory adherence, 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.