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© 2021 MJH Life Sciences and BioPharm International. All rights reserved.
© 2021 MJH Life Sciences™ and BioPharm International. All rights reserved.
Adeline Siew is science editor for BioPharm International.
Andrew Bulpin, head of Process Solutions, MilliporeSigma, shares insights on characterizing CQAs in biopharmaceutical development and the different tests that should be carried out when assessing an investigational drug.
Materials in contact with a drug must be fully characterized to ensure they do not negatively affect the safety and efficacy of the product.
Process analytical technology tools have enabled manufacturers to monitor and control their production processes.
Robust materials management, supplier quality management, quality control, and business continuity planning are essential to ensure continuous supply of single-use bags.