November 2019
Volume 32, No. 11 |
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| COVER STORY |
Feliza Mirasol
Manufacturing differences between traditional mAb therapies and newer biotherapeutics dictate whether processes should be scaled up, scaled out, or use an alternate approach for commercial production.
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| UPSTREAM PROCESSING |
Agnes Shanley
Modeling is being used for everything from yield improvement to facility design, but new initiatives plan to broaden its reach, both upstream and downstream.
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| MANUFACTURING |
Claudia Berron, Gary Dailey
Applying lessons of raw materials’ characterization and supply-chain control from the semiconductor industry allow more rigorous control of the biopharmaceutical manufacturing process.
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Feliza Mirasol
Limitations in traditional flu vaccine manufacturing methods underline the need for shifting to modern technologies.
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| BioPharm International November Issue
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| QUALITY/REGULATIONS |
Cynthia A. Challener
Accelerated timelines and small batch volumes of cell and gene therapies pose unique challenges for product-release testing.
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| PEER-REVIEWED |
Martin Ryner, Nina Forsberg, Vanessa Carvalho, Cristina Peixoto, Sofia B. Carvalho
The authors of this study demonstrate an innovative method that is useful and complements traditional HA assays.
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| ANALYTICS |
Thomas A. Little, PhD
Developing an effective bioassay is crucial for determining the potency of a drug substance or finished drug product. This article gives an overview of how to avoid most problems associated with correct bioassay development.
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| BIOBUSINESS |
Agnes Shanley
Legal experts in biopharmaceutical patent law shed some light on trends and recent news.
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| DOWNSTREAM PROCESSING |
Lauren Lavelle
The latest advances in downstream technologies include stainless-steel liquid chromatography columns, sensing and control units for hygienic valves, a wettable phase for separation and purification, a buffer delivery platform, and a new filter integrity tester.
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| OPERATIONS |
BioPharm International Editors
The following details some of the latest tools and systems available for biopharmaceutical laboratory operations.
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| PERSPECTIVES ON OUTSOURCING |
Susan Haigney
Contract manufacturers are making strategic partnerships and expanding services in the last quarter of 2019.
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| FROM THE EDITOR |
Rita C. Peters
FDA report says drug shortages are underappreciated and patients pay a price.
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| REGULATORY BEAT |
Jill Wechsler
FDA readies more efficient oversight processes while advancing collaboration with Europe.
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| ASK THE EXPERT |
Siegfried Schmitt
It is good industry practice to clarify the precise remit for each of the reviewers of a controlled document, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.
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| EVENTS |
December 4-5, 2019
December 4-6, 2019
December 9–11, 2019
more events
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