Control of integrity assurance can be achieved only through combining a risk-based QbD approach with a selective application of integrity tests and gross leak tests together with visual inspection.
The BPI editors review some state-of-the-art alternatives in upstream and downstream monoclonal antibodies for drug substance bioprocessing as well as drug-product manufacturing.
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This four-part educational series highlights key trends emerging in China biopharmaceuticals, using select content from BioPlan Associates’ 2018 report on the biopharmaceutical industry in China.
With continued double-digit growth in China and the future addition of GE Healthcare’s Biopharma business, Danaher Corporation is poised to strengthen its position in the bioprocess space.
Opportunities abound for the rest of the developed world’s biologics developers, manufacturers, suppliers, distributors, and regulators to participate in the growth of China’s biologics industry.
The survey reveals many different outcomes of focusing on early stage development of advanced formulations, and the potential for overcoming drug development challenges.
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End-to-end and over lifecycle linkage of biopharmaceutical operations, from development to manufacturing of cell and gene therapies is useful in extracting insights for science-based decisions
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In this article, authors at Sartorius Stedim Biotech GmbH detail the evolution of automation for single-use technology towards modular packaging units, including case studies in cGMP processes.
