Search results for " control"
Article
The Affordable Care Act's Impact on Innovation in Biopharma
In the current environment, and especially in locations where hospital systems already control significant market share, moving quickly will enable them to lead in creating and controlling ACOs. The r…
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
Appropriate control of CQAs is a common review concern for both investigational new drug (IND) and license applications.6,7 Product quality characteristics encompass a wide variety of product variants…
Article
What’s in your media? How costly is variability of cell culture media to your manufacturing process?
It helps create a good dialogue between the vendors and us in order to understand where the variations are derived from—as well as how to control them and track them over a period of time.
…
Article
Leveraging Computational Models of Glycosylation for Biopharma QA
Four QA application areas stand out: (i) data analytics, (ii) bioprocess characterization, (iii) cell line engineering/development, and (iv) manufacturing bioprocess optimization and control.
Kine…
Article
Understanding Validation and Technical Transfer, Part 2
A controlled, double-blind study should be conducted to determine which coffee the majority of
tasters prefer to obtain a definition of “good-tasting coffee.” To have a meaningful result, the b…
Article
Understanding Validation and Technical Transfer, Part I
Process validation is documented process understanding and control that begins when it is determined that a cell, molecule, or compound may have clinical significance and ends when the product is no l…
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Impurity Testing of Biologic Drug Products
Control of these steps must be demonstrated by validation and/or quality control checks on the bulk drug substance. Control of impurities that could arise from the fill/finish process are then assesse…
Article
Transformative Medicines Challenge FDA and Manufacturers
… risk management, setting specifications, and assuring compliance with chemistry, manufacturing, and control (CMC) standards for experimental treatments. Presentations covered the importance of contr…
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Reducing Cross-Contamination Risks in Process Chromatography
In addition, disposable flow-paths on single-use downstream processing equipment typically come gamma irradiated, leading to better bioburden control, according to Lundström. Preparatory and post-proc…
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Managing Residual Impurities During Downstream Processing
USP monographs and associated reference standards, according to Atouf, can be used to control product variants during the lifecycle of therapeutic peptide and protein products.
“USP continues to de…