Search results for " HCPs"
Article
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…
Article
Impurity ELISA automation for faster process development
Host cell proteins (HCPs) produced by cells during biologic manufacturing must be removed from the final product to protect patients. However, it’s challenging to detect HCP, and this step can…
Article
Host cell protein quantitation using ELISA
Host cell proteins (HCPs) produced by cells during biologic manufacturing must be removed from the final product to protect patients. However, it’s challenging to detect HCP, and this step c…
Article
Re-use of Protein A Resin: Fouling and Economics
Thus, Protein A is considered to be the most crucial step in the purification process and a major contributor towards achieving the stringent purity levels expected of biotech therapeutics with HCPs r…
Article
Evolution of the Monoclonal Antibody Purification Platform
The authors discuss the evolution of the purification platform for manufacturing of mAb therapeutics.
Monoclonal antibodies (mAb) increasingly form the majority share of the product pipeline…
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The Development and Application of a Monoclonal Antibody Purification Platform
After cation exchange, diafiltration was performed to prepare the product for anion exchange chromatography in flow through mode, in which impurities such as DNA and some HCPs were captured on the res…
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Current Trends in Host Cell Protein Detection for Biologics Manufacturing
Commonly accepted HCP analytical methods, the challenges of HCP assay, and recommendations on what can easily be accomplished in-house and when it may be better to outsource.
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Poster
Comparison of Three Different Screening Techniques for Predicting Step Elution Conditions for a Cation Exchanger
Screening of chromatographic conditions can be done in several ways, such as 96-well plates, mini-columns, and tips. It is important that the screening can give an indication of the optimal conditio…
Article
Moving PAT from Concept to Reality
“Trace metals, glucose, lactate, pH, DO, amino acid content, glycosylation profiles, and HCPs must be measured to monitor the process and enable feedback/feedforward control to optimize yield (in-line…
Article
Impurity Testing of Biologic Drug Products
Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins.
By Adeline Siew, PhD
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