Disposable bioprocess equipment eliminates cleaning and cleaning validation requirements, offering substantial potential savings for manufacturers. As a result, interest is growing in the technologies, and an industry association, the Bioprocess Systems Alliance, has been established to advance best practices, move toward standards and examine safety issues that one doesn't find with stainless steel, including the potential impact of leaching and extraction of plastics materials. The Alliance now includes 50 equipment vendors, but end users will be included next year.
The Interphex show floor is full of examples of plastic bioreactors and mixers, and disposable filtration, sampling and coupling systems, and, as the business grows, so is the competition and merger and acquisition activity is on the rise. GE recently bought Wave Biotech; Millipore bought Novaseptic, which has developed disposable sampling systems, and W.R. Gore bought Amesil, in a strategic move that will shift Gore from supplying materials to OEMs, to supplying them directly to end users. Now there are unconfirmed rumors that Pall Corporation may be planning to buy the bioreactor specialist, ATMI.
