Process remains the determining factor for whether single-use technology is a fit in a bioprocess operation, says Janice Abel, principal consultant at ARC Advisory Group. High-volume production processes are likely to remain steel-based for the foreseeable future, she says, but not necessarily indefinitely.
Abel says in a phone interview that although disposables are seeing rapid adoption among drugmakers whose biopharma products are in development, as well as those adopting processes that are new to their operations, the technology is beginning to penetrate more established bioprocess bastions.
One vaccine maker, for example, is using 10-liter disposable bags to replace stainless steel packaging for shipment to a syringe-filling site. The change was justified on the basis of shipping costs alone, she says.
Such a cost justification is a departure from the more common disposables justifications involving short-run manufacturing for clinical trials and new-process development. Abel says she expects disposables to further penetrate vaccine production, and to become integral in the production of personalized medicines.
High-volume production currently remains problematic for the technology, though. Single-use products generally can't accommodate the 10,000- to 20,000-liter quantities required of some drugs, she says. But even that limitation appears to be diminishing. Disposables-maker Xcellerex currently offers a 2,000-liter single-use bioreactor and has a 5,000-liter model in development, according to Jon Lieber, CFO, via email.
"Disposables are here to stay," says Abel. She is co-author of the recently published Disposables Help Drive Operational Excellence in Pharmaceutical and Biotech Manufacturing, which we reported last week. The technology contributed financial gains to disposables makers Pall and Sartorius Stedim recently.
- here's more on Pall and Sartorius