Single-use bioreactor providing a family of single-use bioreactors from bench-top to full-scale production. Three challenges exist for faster and greater single use bioreactor adoption 1) higher quality and lower cost disposable bags and containers, 2) more reusable and disposable sensors and probes that can provide high quality analytics including real-time cell culture level data points, and 3) a family of bioreactors from lab to production that has full scale-up of the bioprocess. Suppliers are working to improve plastic bag materials and performance and also to develop a broader range of sensors and probes that provide scientists greater insight to cell density, quality
Single-use bioreactor public forums it is a major backer of single use technology in general, as the technology provides significant benefits and value, including mitigation of cross contamination and reduced industry costs. The FDA has stated it will not issue guidance to the industry on single use but "may" issue Q and As on its web site. When an FDA approved single use production site is approved, the gates will open for broader and faster single use adoption worldwide. Already single use has shown itself to be a huge cost saver and to increase process flexibility and operational efficiency for biosimilar applications