Search results for " therapeutic" in Articles / App Notes
Article
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
As a result, they may interfere with one or several functions of this antigen, leading to the therapeutic effect. On the other hand, through the constant regions (Fc), they may interact with Fc-bindin…
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FDA Framework Spurs Advanced Therapies
Three new products were approved in 2017 by FDA, chimeric antigen receptor (CAR) T-cell cancer therapies from Novartis and Kite Pharma and a retinal gene therapy from Spark Therapeutics. Markets and M…
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Transformative Medicines Challenge FDA and Manufacturers
Spark Therapeutics’ Luxturna (voretigene neparvovec) promises to cure a rare genetic eye disorder that causes blindness. FDA reports that some 40 companies are developing CAR-T technologies for multip…
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Roadmap Leads to Innovative Biomanufacturing Strategies
…he biomanufacturing industry has responsibility to bring better, faster, cheaper, and higher quality therapeutics for serving patients. Biomanufacturers are uniquely aware of the challenges faced dur…
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Process Chromatography: Continuous Optimization
Growing diversity
The increased diversity of pipeline therapeutic molecules is a major challenge for chromatographic separation. “The development of novel scaffolds for therapeutic molecules (e.g., …
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Managing Residual Impurities During Downstream Processing
USP, in collaboration with its Expert Committee and Panel members, develops public standards that support the development, characterization, and release of therapeutics. USP monographs and associated …
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Design and Qualification of Single-Use Systems
Greater adoption in the years to come can be anticipated, given their broad use in pre-clinical and clinical manufacturing and expanding use for approved therapeutics. With increasing regulatory overs…
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Biopharma in 2015: A Year for Approvals and Innovations
While the US has approved only one biosimilar therapeutic; Japan, Australia and Europe have approved six, eight and 19 biosimilars respectively. Biosimilars have an exemplary safety track record in th…
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Modular Manufacturing Platforms for Biologics
Caliber Therapeutics, originally a subsidiary of G-CON, LLC until the formation of G-CON Manufacturing Inc. in 2014, was established with Defense Department funding from the Defense Advanced Research …
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Re-use of Protein A Resin: Fouling and Economics
Thus, Protein A is considered to be the most crucial step in the purification process and a major contributor towards achieving the stringent purity levels expected of biotech therapeutics with HCPs r…