More than buzz words

摘要

"I was a bit disappointed not to see more guidance on the use of rapid microbiological methods in the new Annex 1, as with the impending explosion of cell and gene therapies, the demand for them will rise enormously." The words of Andrew Davies, Managing Director of the biotech start-up Microgenetics, underpin prospects for the use of new and pragmatical approaches to environmental monitoring (EM). Those of you working in companies manufacturing in controlled environments and cleanrooms appreciate that real-time monitoring solutions are paramount to anticipate risks of contamination at any production stage. But what difference would it make to have real-time analysis of the EM data? What new technologies are now available or in the works that could help manufacturers control bioburden and prevent spoilage of product? Davies' interview on p30 dives into these and other core challenges that many pharmaceutical companies face every day- cumbersome validation processes, the short shelf life of medicines, you name it-and explains why artificial intelligence and machine learning are tools worth using.