Search results for "biologic"
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ADC Development Robust Despite Lackluster Performance
In one Phase III clinical trial, the company is studying Kadcyla in combination with its anti-breast cancer biologic Perjeta (pertuzumab) as an adjuvant treatment for early-stage HER2-positive breast …
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Development of Purification for Challenging Fc-Fusion Proteins
Introduction
Improvements have been made in mammalian cell culture to achieve high productivity processes primarily to meet the increasing demand of biological therapies. In response, tit…
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Manufacturing Standards Key to Advancing Cellular and Gene Therapies
…ation setting, and for establishing relevant manufacturing controls for these highly perishable and biologically complex products.
Experts from biopharma companies and research organizations …
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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
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…