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
… the natural, simultaneous production of other unwanted materials, particularly host-cell proteins (HCPs). Host-cell DNA will also be present and must be minimized by the purification process. Elemen…
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Eliminating Residual Impurities Starts with a Strategic Plan
Others are more complex to define, such as those that originate from the cellular system including residual DNA or host-cell proteins (HCPs),” Wake observes. “In the latter case, for instance, conside…
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Development of Purification for Challenging Fc-Fusion Proteins
As tested on three Fc-fusion proteins, this process demonstrates high process yield, improved clearance of HMWs and LMWs, and efficient reduction of host cell proteins (HCP) and DNA as well as robust …
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Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification
This step often requires more optimization than initial capture and/or final polishing and aims to achieve high-dynamic binding capacity and maximum aggregate and host-cell protein (HCP) clearance. In…
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Updating Viral Clearance for New Biologic Modalities
Because viruses are typically smaller than downstream impurities such as host cell proteins (HCPs) and other extracellular debris, they require meticulous filtration, even in more established processe…