Search results for " hcp"

Article Why, why, why…ELISA? A Look at the Benchmark HCP Assay
Biologics developers and manufacturers demand an accurate and reliable assay for host cell protein (HCP) quantitation. Let’s take a close look at why analytical scientists turn to the ELISA and how it…

Article News: GE Healthcare Adds ELISA Kit to End-to-End HCP Monitoring Capabilities
GE Healthcare Life Sciences 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. Learn Mor…

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 Polishing of monoclonal antibodies using Capto adhere ImpRes in bind and elute mode
Contaminants such as DNA, HCP, leached protein A, aggregates, and viruses are efficiently separated from monomeric MAbs1 in B/E or FT modes. This application note describes development of polishing st…

Article Polishing of Monoclonal Antibodies using Capto™ MMC ImpRes in Bind and Elute Mode
This Application note describes a fast and efficient method to separate monomeric MAb from aggregates, HCP, and protein A remnants. The method described includes screening for optimal binding conditio…

Article 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,…

Article 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…

Poster Host Cell Proteins beyond ELISA with label free interaction and imaging technologies
However, the levels of individual HCP may be independently affected by adjustments in cell culture and purification conditions during process development, suggesting that there is a need consider addi…

Article Downstream scale-up purification of influenza virus using ReadyToProcess equipment
Outcome of the pre-study Figure 5 A to D summarizes the results from the pre-study in terms of HA yield (%), host cell DNA-to HA ratio, total proteinto-HA ratio, and HCP-to-HA ratio. Similar proces…

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