Search results for " biologic" 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
Manufacturing systems for any biological product normally entail multiple revisions and improvements throughout the product lifecycle, and biosimilars are expected to follow this pattern. The regulato…
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Improving Process-Scale Chromatography
By Cynthia Challener, PhD
Chromatography is a crucial step in the purification of biopharmaceuticals and accounts for a significant portion of downstream processing efforts (time and cost) for bio…
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Modeling Bioreactor Performance
“Ultimately, researchers aim to translate the hydrodynamic/physical parameters to the biological environment and to predict the biological system (e.g., cell growth and productivity) at different scal…
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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
Cell-culture process development
Development of an efficient, robust, and reproducible cell-culture process is key for successful market supply of a biologic drug. Depending on project requirement…
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Continuous Processing for the Production of Biopharmaceuticals
… no concrete examples of successful implementation and integration of a fully continuous process for biologic products. The true potential of continuous bioprocessing can only be realized after succe…
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Going Small to Achieve Success on the Commercial Scale
Challener
Biopharmaceutical manufacturing involves a series of complex unit operations linked together to provide high-purity, biologic actives with specified physicochemical and pharmacokinetic p…
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Tools for Continuous Bioprocessing Development
The FDA ruling stated that the glycosylation of the products manufactured at each scale differed, and, thus, the 2000-liter product required a new biologic license application (1).
Why is process …