Search results for "Protein A"
Article
Application of Quality by Design to Viral Safety
…ance process design spaces for two unit operations commonly used in monoclonal antibody production, Protein A and anion exchange chromatography (12, 13). For Protein A chromatography, Genentech found…
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Q&A with Industry Leader Konstantin Konstantinov, Genzyme Vice-President
This week we speak with Konstantin Konstantinov, Genzyme Vice-President Late Stage Process Development, about developments in continuous processing.
Q: You’re part of an upcoming sym…
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2014 Manufacturing Trends and Outlook
Protein aggregates, formulation issues, creating/cloning cell lines, regulatory issues, and analytics were mentioned by more than 25% of the respondents (see Table I).
Nucleic-acid based drugs.…
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Regulatory Challenges in the QbD Paradigm
The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends.
With the dawn of the 2…
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Recap: Chromatography + filtration virtual summit 2024
Did you miss the Chromatography + filtration virtual summit 2024? Don’t worry – here are the highlights and session recordings from the event on optimizing purification and filtration for mAbs…
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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…
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Get Started: Purification of mAb Variants - eLearning
The success of monoclonal antibodies (mAbs) as therapeutics and the multi-domain structure of antibodies has made it possible to create antibody variants, such as bispecific antibodies (bsAbs)…
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Report from the 6th International HTPD Conference
The biggest challenge is still the people and Quantitative Structure-Activity Relationship (QSAR) plus mechanistic modeling were two key take-home messages from the 6th International conference devote…
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Chromatography processes for the diversified therapeutic antibody pipeline
The diversity of antibody variants in today’s pipeline presents unique challenges for purification and we see molecules such as bsAbs, Fabs, dAbs, and others. Conventional chromatography protocols, …
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How to program, run and evaluate a design of experiments (DoE)
In this free, interactive course, Dr. Martin Sichting, Product Manager Lab Scale Chromatography Systems at Cytiva, guides you through the DoE process.
You’ll learn how to program, run, and e…