04.04.23
Bikash Chatterjee, CEO of Pharmatech Associates, a USP company, says 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.
Chatterjee made his comments ahead of a CPHI North America panel discussion, Redesigning the Supply Chain – The Road to Increased Resilience.
According to Chatterjee, 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.
He 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.
Chatterjee said that two technologies that bode well for increased supply chain resilience are continuous manufacturing and multi-tenant architectures for cross-party data sharing. He says that equipment for continuous manufacturing has advanced considerably and is now cost-effective and easier to operate in a PAT environment.
“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,” said Chatterjee. “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.”
Chatterjee noted that demand for domestic manufacturing in the U.S. is incredibly high and many of the smaller and mid-sized CDMOs are staying with partners in development for much longer. He argues these companies are where the biggest opportunities are for installing pharmaceutical continuous manufacturing. According to Chatterjee, 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.
Chatterjee pointed out that 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 sure they have built in the required documentation and resilience into the supply chain.
Chatterjee said 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 said, “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.”
Chatterjee made his comments ahead of a CPHI North America panel discussion, Redesigning the Supply Chain – The Road to Increased Resilience.
According to Chatterjee, 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.
He 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.
Chatterjee said that two technologies that bode well for increased supply chain resilience are continuous manufacturing and multi-tenant architectures for cross-party data sharing. He says that equipment for continuous manufacturing has advanced considerably and is now cost-effective and easier to operate in a PAT environment.
“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,” said Chatterjee. “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.”
Chatterjee noted that demand for domestic manufacturing in the U.S. is incredibly high and many of the smaller and mid-sized CDMOs are staying with partners in development for much longer. He argues these companies are where the biggest opportunities are for installing pharmaceutical continuous manufacturing. According to Chatterjee, 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.
Chatterjee pointed out that 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 sure they have built in the required documentation and resilience into the supply chain.
Chatterjee said 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 said, “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.”
