Search results for "Mabs" in Articles / App Notes
Article
Ensuring the Quality of Biologicals
has established general monographs that cover common quality attributes and that are applicable to a specific class of biologicals such as monoclonal antibodies (mAbs), rDNA products, or vaccines for …
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What Drove Biopharma Development in 2014?
Process Development Forum (PDF) featured a myriad of topics at the forefront of biopharmaceutical development. But some issues stood out as garnering the most attention from readers in 2014. One of …
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Viral Clearance Challenges in Bioprocessing
“This practice is not in full compliance with current guidelines, but some agencies have accepted this type of data for IND applications of mAbs [monoclonal antibodies] derived from CHO [Chinese hamst…
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Challenges in Analytical Method Development and Validation
Experts give insight on method transfer, QbD, and regulations for analytical method development and validation for biopharmaceuticals.
The manufacture of biopharmaceuticals presents …
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Predicting Progress in Protein Aggregation
Techniques to enable the design and formulation of stable, protein-based therapeutics.
In silico analysis and the evaluation of formulability, aided by new analytical tools such as hydrogen deut…
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ReadyToProcess WAVE 25 Bioreactor System
The single-use ReadyToProcess WAVE 25 bioreactor system is a reliable and intuitive cell culture device for working volumes up to 25 L.
The system is based on a well-known rocking technology tha…
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Stirring up the fermentation game
Microbial fermentation in single-use Xcellerex™ XDR-50 MO fermentor system
This application note describes the performance of a single-use Xcellerex XDR-50 bioreactor system when used in culti…
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Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
On February 9, 2012, almost two years after the Biologics Price Competition and Innovation Act was passed, FDA released draft guidelines concerning the regulatory path for biosimilars. Amy Ritter, S…
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Quality by design for biotechnology products—part 1
Understanding the structure and functional attributes of therapeutic proteins, including monoclonal antibodies (MAbs), is key to developing the design space, because that understanding facilitates the…