05.17.21 -- Are You Ready For The FDA's "Data Effect" Tsunami? 8 Steps To Prepare
05.17.21 -- Are You Ready For The FDA's "Data Effect" Tsunami? 8 Steps To Prepare State-of-the-art continuous manufacturing technologies are being developed and implemented to manufacture a wide variety of products. Several vendors offer development-scale to commercial-scale continuous downstream chromatography systems. When adopting continuous technology, it is critical to demonstrate that continuous downstream processes are comparable to batch-mode downstream processes and provide the supporting comparability data for technical and business decisions....