Despite years of discussion and experience, E&L testing approaches for single-use equipment have not yet fully matured into a consensus industry practice. Copious amounts of data have been generated by the industry, but most of it is held under confidentiality. Trade organizations, such as the Bio-Process Systems Alliance (BPSA), of which GE is a member, and suppliers have derived their own approaches to testing. For end users who are adopting single-use (SU) equipment as a manufacturing strategy, this situation becomes unwieldy. The need for a standard approach both to the generation and to the reporting structure of extractables data becomes obvious.
Sosei Group Corporation recently announces that Heptares Therapeutics (“Heptares”), the wholly-owned subsidiary of Sosei, has signed a share purchase agreement that will allow the acquisition of 100% in G7 Therapeutics, a privately held drug discovery and development company based in Switzerland, for CHF 12 million cash