Search results for "antibodies" in Articles / App Notes
Article
2014 Manufacturing Trends and Outlook
… Almost 45% of the respondents reported that their organizations manufacture therapeutic monoclonal antibodies (mAbs); more than 55% of those surveyed said they manufacture protein-based drugs other …
Article
Drugs, At What Cost?
Monoclonal antibodies and human insulin will spur this growth.
Competition generated through established biosimilar pathways will drive down the high costs of biologics in Europe, the US, and s…
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Best Practices in Adopting Single-Use Systems
Moreover, the 5- to 10-fold improvement in product titers for monoclonal antibodies over the past 15 years has nearly eliminated arguments against single-use based on scale. Bioprocessors can now gene…
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Trends in Downstream Bioprocessing
Downstream processing involves the recovery and purification of protein therapeutics for biopharmaceuticals, vaccines, and other biologics. It involves the removal of insoluble cell debris and parti…
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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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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…
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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…