Recent revisions to EU manufacturing guidelines are changing how drug makers test processing technologies, according to the author of a new study, who cites growing use of an approach known as PUPSIT ...
This partnership will fuel the rapid expansion of skids, testing technologies, and single-use assemblies for biopharmaceutical manufacturers operating in GMP-regulated environments. MALVERN, Pa., ...
RADNOR, Pa., Oct. 30, 2025 /PRNewswire/ -- Avantor, Inc. (NYSE: AVTR), a leading global provider of mission-critical products and services to customers in the life sciences and advanced technologies ...
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Scaling up production is a key stage in the lifetime of a monoclonal antibody (mAb), fraught with the risk of product quality issues, consistency challenges, and problems with low yield or line loss.
The implementation of pre-use, post-sterilization integrity testing (PUPSIT) has been the subject of long-standing discussion. The recent EU GMP Annex 1 revision reflects these discussions, ...
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