Search results for " therapeutic"
Article
Updating Viral Clearance for New Biologic Modalities
… removal are well established and their effectiveness has been confirmed by the safety record of the therapeutics they were used to manufacture, adds Darren Verlenden, head of BioProcessing at Millip…
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Next Generation Process Chromatography
Without it the industry would not be able to produce therapeutics in an economic manner. This is true for monoclonal antibodies (mAbs) that present the modern age in terms of fighting diseases such as…
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Biosimilar Quality Requirements
In May 2019, the agency published the draft guidance Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations (1) and the guidance Con…
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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…