Search results for " HCPs"
Article
Manage HCPs and Enhance Your Route to Market
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Host cell protein (HCP) management is critical to biologics development—and getting it wrong could delay your development cycle. Learn how the right HCP strategy can enhance…
Article
Manage HCPs and Enhance Your Route to Market
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Host cell protein (HCP) management is critical to biologics development—and getting it wrong could delay your development cycle. Learn how the right HCP strategy can e…
Article
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…
Article
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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Article
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…
Article
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; …
Article
Eliminating Residual Impurities Starts with a Strategic Plan
“The method must be sufficiently sensitive or cross-contamination can occur, which can be a safety issue, particularly with HCPs, which are known to have an immunogenic response at low levels,” he com…
Article
Development of Purification for Challenging Fc-Fusion Proteins
Development of Purification for Challenging Fc-Fusion Proteins
This study outlines methods for an alternative protein-polishing process for challenging proteins.
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Article
Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification
Optimization of each phase in a chromatographic cycle has a positive impact on productivity.
By Anna Grönberg
An important area of focus for the biopharma industry is the elucidation and dev…
Article
Updating Viral Clearance for New Biologic Modalities
Thus, for example, one reduces the HCPs generated by a cell line by manipulating the buffers and chromatography chemistries to separate the product. In such cases, viruses are absent, and their presen…