Search results for " biologics"
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ADC Development Robust Despite Lackluster Performance
ADC Development Robust Despite Lackluster Performance
Despite the disappointing therapeutic performance of ADCs thus far, the pipeline still boasts promising prospects.
By Feliza…
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Development of Purification for Challenging Fc-Fusion Proteins
All are at Patheon Biologics.
*To whom correspondence should be addressed.
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Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
FDA works with industry on strategies for assuring high-quality regenerative medicines.
By Jill Wechsler
…
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Downstream Processing for Cell-Based Therapies
Unlike the traditional manufacture of monoclonal antibodies (mAbs) and other biologics, the production and processing of cellular material forms the basis of the product for CGTs (1). As such, manufac…
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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…
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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…
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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…
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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…