Search results for " impurities"
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Challenging Host Cell Protein Assays for Improved Risk Mitigation
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This webinar shares Cytiva’s strategy for designing a comprehensive host cell protein (HCP) risk mitigation strategy. We will address how to challenge your assays ea…
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Technology Innovations Improve Process Chromatography Performance
“The higher the titer, one can expect to see a corresponding increase in the level of impurities, increasing the need for depth filter area downstream. A practical way to address this productivity inc…
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Understanding and Controlling Raw Material Variation in Cell Culture Media
Manage variability through advanced analytical methods and risk-based assessment.
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Good Manufacturing Practices: Challenges with Compliance
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The complexity of biologics and the use of new technologies present challenges for complying with CGMPs.
By Lauren Lavelle
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Optimizing Drug Safety and Efficacy of Complex Next-Generation Biologics
In recent years, the global biopharma industry has seen a rapidly advancing trend toward biotherapeutics or ‘biologic’ drugs—drugs that are produced from living organisms or contain components of li…
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Driving Improved Access to Biosimilars
Driving Improved Access to Biosimilars
New guidance from FDA, including standards for interchangeability, is expected to speed development of biosimilars, but experts warn against oversimplifying ri…
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Moving PAT from Concept to Reality
…matography coupled with ultraviolet, fluorescence, or MS detectors for evaluation of process-related impurities; and variable pathlength spectroscopy solutions for protein concentration measurement i…
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An Analytical Approach to Biosimilar Drug Development
Specifically, these tests are designed to cover the primary, secondary, and higher order of protein structures; the purity and impurities; the post-translational modification, such as glycan profiles;…
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News: Cytiva Adds ELISA Kit to End-to-End HCP Monitoring Capabilities
Cytiva is pleased to announce the new Amersham HCPQuant CHO kit, a generic for detecting host cell protein impurities in drug samples produced in CHO cell lines.
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Biopharmaceutical Process Development: 2018 Lessons and 2019 Predictions
The biopharmaceutical industry continues to expand in new and exciting ways. What might be in store for 2019, and what important lessons should process developers take from 2018? Here, we look back …