During a discussion at BIO in San Francisco this week focused on the biomanufacturing landscape, Steve Lam, head of biologics at contract development and manufacturing organisation (CDMO) Patheon, said his firm was exploring a number of different models to help overcome a lack of production capacity in the biopharma sector.
“There’s a real hunger out there for capacity,” he said, especially for small and mid-sized companies which – unlike a firm with a large pipeline - are unable to diversify their capacity forecasting risk across multiple products.
“Because of the new technologies that are coming in, in terms of single-use which has led to smaller reactors, there are opportunities but [contract manufacturers] are going to have to be creative.”
Therefore Patheon has begun exploring a number of models for its customers, and while some are well established among CDMOs, others “look a little different:”
Traditional model: As the name suggests, this would be a CDMO offering up fixed capacity to a biopharma firm with flexibility in reactor size and manufacturing process design and – Lam said – has historically been the standard approach.
Dedicated facility: “An innovator company will go out to a contract manufacturing company and ask for a dedicated facility to be built for them so they can control it as if it’s their own facility, but without creating the internal tactical competency or commit to a build,” he said.
Fractional ownership: While Lam has yet to have seen this model in operation, “we are seeing multiple partners coming to us and, in a way, asking us to act as a broker.” This would essentially see a single facility built for several clients, offering flexible capacity but within defined bands.
Global Network Access: This involves utilising a pre-existing manufacturing network for clients with perhaps uncertain manufacturing schedules and demands to have full access within an agreed upon notice.
Condominium: This model allows a customer to have a customised manufacturing suite within a larger site. “Clients can then take advantage of the fixed overheads of the entire site and the cost of goods, while benefitting from full flexibility.”
Enterprise: Such a model would see a CMO move into and manage a facility owned by the biopharma firm itself, allowing the innovator company to dedicate its own staff to perhaps new, more complex developments.