Pascal Valax
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View article: Host Cell Protein Clinical Safety Risk Assessment—An Updated Industry Review
Host Cell Protein Clinical Safety Risk Assessment—An Updated Industry Review Open
Host cell proteins (HCP) are process‐related impurities that can co‐purify with therapeutic proteins. Some HCP impurities potentially can have an impact on patient safety (immunogenicity or toxicity), efficacy, and/or product quality. It i…
View article: Managing integrated continuous bioprocesses in real time: Deviations in product quality
Managing integrated continuous bioprocesses in real time: Deviations in product quality Open
The N‐mAb case study was produced by the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) to support teaching and learning for both industry and regulators around adoption of advanced manufacturing process tec…
View article: Biotechnology and Bioengineering: Volume 118, Number 8, August 2021
Biotechnology and Bioengineering: Volume 118, Number 8, August 2021 Open
Improving ethanol produc on by studying the eff ect of pH using a modifi