Last week's testimony concerning the creation of a public/private partnership involving the U.S. Department of Health and Human Services for a medical countermeasures vaccine manufacturing facility is being viewed as a well-timed boost for the technology.
Concerning specifics on the use of disposable technology in the University of Pittsburgh Medical Center's pitch to Congress, "It can serve as a catalyst to open up the disposables industry," says Joseph Zakrzewski, CEO at Xcellerex, a maker of disposable bioreactors and mixing systems as well as a CMO and biomolecule co-developer. It may lead to a rising tide that will float all disposable-technology makers' boats. In the fledgling days of commercial acceptance of the technology, Zakrzewski acknowledges that, when it does happen, he always prefers to lose a sale to another disposables maker rather than a provider of the more traditional stainless steel technology.
And at Pall Life Sciences, Hélène Pora, senior director for single-use systems, and Jerold Martin, senior VP for scientific affairs, say in email correspondence that any government acceptance of flexible vaccine manufacturing will further encourage its use among emerging biotechs as well as commercial vaccine and biopharmaceutical manufacturers.
The vaccine and biopharma industry, however, "is very conservative and generally slow to adopt new technologies without indication of government acceptance. Congressional support of the proposal will be very encouraging for the adoption of single-use manufacturing approaches."
Pall notes that some drug makers are retrofitting or building new manufacturing suites for processes that incorporate single-use technologies, allowing flexible and even portable factories. "Single-use technology is also now widely accepted in the vaccine industry because it fits quite well the scale of operation."
- here's the UP Medical Center announcement
- see our coverage of Congressional testimony