Search results for " impurity"
Article
What’s in your media? How costly is variability of cell culture media to your manufacturing process?
We noticed that when we compare from different vendors or the same vendors there is inherent variation in the trace impurity profiles. Once we see this variation, we go back to the source which the va…
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Development of Purification for Challenging Fc-Fusion Proteins
Under the cation exchange chromatography conditions tested, the efficient impurity removal was obtained up to 300 mg/mL-resin load ratio with starting HMWs level of 5% and LMWs of 18%.
Th…
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Reimagining Affordable Biosimilars
Geigert, “Complex Process-Related Impurity Profiles,” In The Challenge of CMC Regulatory Compliance for Biopharmaceuticals (Springer, Cham, Switzerland, 3rd ed., 2019), pp. 231-260
J. Gokemeije…
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Process Chromatography: Continuous Optimization
Improved resin chemistries and customized separation solutions are enabling more efficient separations.
By Cynthia A. Challener
Cell-culture and fermentation are high-…
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Host-Cell Protein Measurement and Control
However, this protein was detected on capillary electrophoresis-sodium dodecyl sulfate (CE-SDS) as an impurity peak with a ~2000 ng/mg relative concentration in bulk drug substance. Additionally, some…
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The Development and Application of a Monoclonal Antibody Purification Platform
…l unit operations have been affected by increasing cell culture titers and subsequent changes in the impurity profile, as well as viral clearance issues. The platform was developed to maximize the ef…
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Updating Viral Clearance for New Biologic Modalities
Improvements in chromatographic separations designed to maximize HCP and impurity removal have often resulted in higher levels of viral clearance as well, he says, pointing to MilliporeSigma’s chromat…
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Quality by Design and Extractable and Leachable Testing
How does one set up a testing program to ensure none of these potential components are contaminating the final product? Is it reasonable to test for every potential impurity?
A standard extracta…
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Top Tips for Successful Development of Antibody Chromatography Processes
Is it stable? And what is the challenging impurity that you're trying to solve? These things will help you build a strategy towards different impurities. If you end up in a certain challenge, you know…
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Enhancing Resins Addresses Purification Concerns
Deorkar points out that a major challenge in rAAV purification is the removal of empty capsid particles, which is an impurity generated during upstream processing. “These empty capsids do not contain …