Search results for "Protein"

Article Application of Quality by Design to Viral Safety
Each unit operation is likely to contribute to or impact other CQAs like host cell protein removal for chromatographic steps, for example. Therefore, the definition of an acceptable design space for e…

Article Q&A with Industry Leader Konstantin Konstantinov, Genzyme Vice-President
In addition, continuous processing offers biotechnology companies increased flexibility—you can use the same platform for various types of therapeutic proteins. More flexible management of manufacturi…

Article 2014 Manufacturing Trends and Outlook
…ure therapeutic monoclonal antibodies (mAbs); more than 55% of those surveyed said they manufacture protein-based drugs other than mAbs. More than 40% of the respondents said their companies manufact…

Article Regulatory Challenges in the QbD Paradigm
This model is especially evident in FDA's Center for Drug Evaluation and Research (CDER) as used for therapeutic biological products, such as proteins and monoclonal antibodies. These products were tr…

Article Recap: 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, antibody variants, recombinant proteins, and gene therapy. See highli…

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 Get Started: Purification of mAb Variants - eLearning
These molecules show wider variation in binding affinities and are often more challenging to separate from impurities, such as host cell proteins (HCP), host DNA, aggregates, and isoforms. In this …

Article Report from the 6th International HTPD Conference
The QSAR model by Merck has been developed and trained with 10,000 data points from historical data on 40 proteins (mainly mAbs but a few Ab variants) and 51 resins. Calculated descriptors for protein

Article 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, …

Article How to program, run and evaluate a design of experiments (DoE)
An application example showcases how to optimize an antibody purification for low dimer-and-aggregate and host cell proteins (HCPs) content while achieving best possible yields. Take the course now…

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