Catalent has replaced all stainless steel bioreactors at its biologics facility in Middleton, Wisconsin with single-use techs citing cost and flexibility advantages.
Speaking to Outsourcing-Pharma.com, Michael Jenkins – general manager of the facility – said the firm has recently replaced several of its stainless steel reactors with disposable counterparts.
He said the speed, flexibility and productivity afforded by single use tech falls in line with the firm’s contract manufacturing mantra, and is especially beneficial for its GPEx cell expression technology.
“The lower costs of building out a single use facility and the lower equipment costs are compelling. Additionally, these units have advantages in the area of line clearance and flexibility,” he told us.
However, though Jenkins believes single use is on the rise in the world of biomanufacturing, he thinks Catalent will be one of the only providers to take the plunge with a complete overhaul.
“Traditional facilities are quite functional and we do not think we will observe many companies abandoning fully operational stainless steel bioreactor facilities for SUB facilities - that said that is exactly Catalent’s strategy,” he said.
“I really feel this will be more of an exception to the rule and there are less extreme ways to leverage the advantages of single use products in the current manufacturing process.”
Jenkins added that a more common way firms will adopt disposables will be in ancillary areas, where traditional mixing vessels can be replaced with one use equipment – such as in buffer preparation and downstream processing.
“Single use systems provide substantial value in multiple product facilities,” he said. “On the financial side, facilities are less expensive to build and run. On the technical side, project changeover is faster, and the systems are essentially closed lowering contamination risk.”
Jenkins admitted, however, that for large scale production – between 5,000ltr to 20,000ltr – fixed systems have better cost benefits because there is much less need for changeovers and handling.
“I think I have a reasonable imagination, but I cannot imagine a 20,000ltr single use bioreactor. At this scale, conventional technologies are at least for the foreseeable future, the best solution,” he said.
But as Catalent’s expression tech can still produce up to 5,000 grams of product using a 1,000ltr vessel, he said the single use is still “well within” target customers’ requirements, and that “the output we can generate in 1,000tr are comparable to much larger units.”
He added that technology improvements for the industry in general has seen enhancements in protein output from smaller systems, saying that “ultimately, this has minimised the need for 20,000 ltr capacity.”
Jenkins also added that a predicted shift in the biologics industry towards personalised meds rather than blockbuster products will also ensure the growth of single use technology stays constant.
He said: “Single use manufacturing allows for dedicated equipment per batch to minimize the infrastructure requirements, lower the fixed costs associated with manufacturing and ultimately strive to make targeted medicines a reality.”