Search results for " biologics" in Articles / App Notes
Article
Biopharma in 2016: Higher Quality Drugs, Less Expensive Manufacturing
President Trump has promised to repeal and replace the Affordable Care Act (ACA), but what impact might this have on biosimilar development? As part of the ACA, the Biologics Price Competition and Inn…
Article
Drug Quality Key to Innovation and Access
The increase in combination products, moreover, demands more coordinated oversight of manufacturing by FDA’s centers for drugs, biologics, and medical devices.
FDA is responding with efforts to re…
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Biosimilars to Drive Modern Manufacturing Approaches
Reliable, high-quality products require innovative analytics and production.
By Jill Wechsler
As more biosimilars gain market approval in the United States, and manufacturers launch addition…
Article
Improving Process-Scale Chromatography
Advances in technology are increasing the productivity and efficiency of commercial-scale chromatography bioprocesses.
By Cynthia Challener, PhD
Chromatography is a crucial step in the purif…
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Modeling Bioreactor Performance
Model effectiveness is determined by the quality and composition of the data inputs.
By Cynthia A. Challener
Bioreactor design, including the geometry of the tank and impeller and the locati…
Article
Innovation vs. Capacity: How CMOs Compete
The contract and manufacturing organization (CMO) industry can be segmented along obvious lines such as API versus drug product manufacturers, biologics versus small molecule, dose form(s) manufacture…
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Platform Approach Speeds Process Development
A modular cell-culture platform demonstrates accelerated process development.
By Harald Bradl, Jan Bechmann, Benedikt Greulich, Markus Michael Mueller, Patrick Schulz, Thomas Wucherpfennig
C…
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Continuous Processing for the Production of Biopharmaceuticals
Path forward
While the adaptation of continuous manufacturing strategies in biologics may have been slow, the field is evolving. The significant benefits that continuous processing offers—includin…
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Going Small to Achieve Success on the Commercial Scale
Scale-down modeling is instrumental in supporting the development of downstream biopharma manufacturing processes.
By Cynthia A. Challener
Biopharmaceutical manufacturing involves a series o…
Article
Tools for Continuous Bioprocessing Development
Why is process transfer hard?
Scale up and scale down are well-known barriers to biologics production. Because volume and surface area scale differently with length, even in similar benchtop biorea…