Search results for " protein" in Articles / App Notes
Article
DoE Provides Benefits, but Preparation Is Necessary
Nguyen also notes that depending on the data that are generated from an experimental design, it is sometimes possible to gain some mechanistic understanding of protein stabilization or behavior.
I…
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
…ture 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 manufac…
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, …