Feature article - CDMO supply chain issues ‘often overlooked’
CDMO supply chains “are potentially the biggest single risk to product resilience, yet they remain an area often overlooked by drug sponsors in partnering criteria”, said Bikash Chatterjee, CEO of Pharmatech Associates during a panel entitled ‘Redesigning the Supply Chain – The Road to Increased Resilience’. This was held as part of the online element of CPHI North America.
Demand for domestic manufacturing in the US is “incredibly high”, Chatterjee noted. Many large CDMOs running at capacity, and consequently, smaller and mid-sized CDMOs are staying with partners in development for much longer.
In addition, biotechs often rely wholly on CDMOs for their regulatory needs, which are growing in parallel with demand. CDMOs are also answering many questions when it comes to an approval or pre-approval inspection, so launch timelines and regulatory risk are also now effectively outsourced. This reinforces the need for sponsors to build in the required documentation and resilience into the supply chain.
“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,” Chatterjee said.
In this context, he highlighted continuous manufacturing as one technology that can help boost supply chain resilience. The equipment in this area has made big strides forward and is now easier to operate in a PAT environment, as well as easier to clean and maintain.
“With the integration of control and PAT sensors with feeders, the equipment evolution is the real game-changer 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.”
Another key technology here is multi-tenant architectures for cross-party data sharing, which can enable partners in a drug supply network to work longer toward approval. If smaller and mid-tier firms would invest in these technologies, as well as staff with approval experience, it could do much to avoid the rising risks of supply chain problem within the US this year.