Ahead of a CPHI North America panel discussion, “Redesigning the Supply Chain – The Road to Increased Resilience,” Bikash Chatterjee, CEO of Pharmatech Associates, a USP company, forewarns that CDMO supply chains are potentially the biggest single risk to product resilience, yet remain an area often overlooked by drug sponsors in partnering criteria.

With many of the largest CDMOs now running at capacity, drug sponsors will need to focus on mitigating risk and building resiliency when using smaller or mid-sized CDMOs. Ahead of the conference, Chatterjee suggests that with demand for services increasing at the same rate as U.S. regulatory burdens, both CDMOs and sponsors need to be looking at their supply chain today to avoid the risks of tomorrow.

The 2023 edition of CPHI North America will bring thousands of pharma professionals from more than 80 countries to the Pennsylvania Convention Center (April 25-27th) to meet, connect and attend high-level conference sessions, where leading CDMOs will seek to address capacity challenges and supply chain contingencies.

Two technologies that bode well for increased supply chain resilience are continuous manufacturing and multi-tenant architectures for cross-party data sharing. Chatterjee suggests that equipment for continuous has advanced considerably and is now cost-effective and easier to operate in a PAT environment. He added, “systems are much easier to clean, easier to maintain, and this has tremendously reduced the barriers to entry for manufacturers. And now with the integration of control and PAT sensors with feeders—the equipment evolution is the real gamechanger for adoption. The irony is that much of the anxiety around installing continuous solutions is the added perceived risk, yet they actually reduce the manpower needed and, of course, are inherently more resilient for control and processes.”

Demand for domestic manufacturing in the U.S. is incredibly high and consequently, many of the smaller and mid-sized CDMOs are staying with partners in development for much longer. Chatterjee argues these companies are where the biggest opportunities are for installing pharmaceutical continuous manufacturing. The other issue identified is that many smaller biotechs, who rely on CDMOs as their regulatory guardians, are choosing local manufacturers as a strategy for reduced supply chain risk. “What I will suggest to the pharma sponsors is to probe much deeper and look at the CDMO’s suppliers’ suppliers, as there are obvious risks to security of supply—find out if supplier instability could halt production,” continued Chatterjee.

CDMOs are also answering many questions when it comes to an approval or pre-approval inspection (PAI), so launch timelines and regulatory risk are also now effectively outsourced. That is why sponsors will need to be incredibly sure they have built in the required documentation and resilience into the supply chain.

Chatterjee stated that 2023 is potentially the year we see this risk manifest in some real-world supply chain problem within the U.S. Yet much of this can be avoided if smaller and mid-tier firms invest not only in staff with approval experience, but a number of newer technologies that can dramatically improve supply chain robustness. The first is to bring data transferability between all partners in a drug supply network using multi-tenant architectures, and this will enable them to work longer toward approval. He added, “we are moving to a regulatory environment where you will need not just GMP practices but visibility on all data. Added to this, your CDMO is responsible for product recalls, so their ERP systems are central to traceability in your supply chain to back navigate the ingredients. This is rarely a question on audits but is crucial to the sponsor’s supply chain reliability.”

CPHI North America will run as a hybrid event, with its digital platform opening ahead of the in-person event and continuing for two months post show. The online platform offers opportunities to partner and network remotely, catch up on content sessions and browse products and solutions from March 16th through May 12, 2023.

Sarah Griffin, Manager, Pharma Brand U.S. at Informa Markets, said, “After speaking with delegates and experts we have designed a content and partnering program to reflect the real challenges and opportunities ahead in 2023. What is undoubted, is the importance of nurturing deeper supply chain partnerships, meeting in person and widening your networks. The U.S. has tremendous growth potential, but this is built on the back of the quality of your pharma network both locally and international.”

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