Search results for " hcp"
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Manage HCPs and Enhance Your Route to Market
Learn how the right HCP strategy can enhance your route to market.
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Manage HCPs and Enhance Your Route to Market
Learn how the right HCP strategy can enhance your route to market.
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Why, Why, Why…ELISA? A Look at the Benchmark HCP Assay
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Biologics developers and manufacturers demand an accurate and reliable assay for host cell protein (HCP) quantitation. Let’s take a close look at why analytica…
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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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Host-Cell Protein Measurement and Control
The amount of residual HCPs in drug product is generally considered a critical quality attribute (CQA), due to their potential to affect product safety and efficacy. Therefore, it is a regulatory requ…
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Managing Residual Impurities During Downstream Processing
There is, however, no set of standard assays for the determination of contaminants such as HCPs during manufacturing because each biopharmaceutical process is unique and results in unique impurities; …
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Eliminating Residual Impurities Starts with a Strategic Plan
“In the latter case, for instance, consideration must be made for total HCP levels per regulatory guidance, but also for any single HCP of particular concern, for which a more specific monitoring appr…
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Development of Purification for Challenging Fc-Fusion Proteins
Anion exchange chromatography (AEX) (6-8, 10-11), typically serves as a polishing chromatographic step operated in flow-through mode, binding process-related impurities such as HCP, DNA, leached ProA,…
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Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification
A 2–4 fold reduction in HCP was observed following the cation exchange polishing step (see Table I).
Table I: Effects of different binding and elution conditions on monoclonal antibody (mAb) aggre…
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Updating Viral Clearance for New Biologic Modalities
Generally, viral clearance methods for these processes remove known impurities, such as DNA and HCP, by using assays that were developed and evaluated for a specific cell line, says Berrie. Thus, for …