Search results for " innovation" in Articles / App Notes
Article
Driving Improved Access to Biosimilars
Almost a year after FDA formally issued its Biosimilars Action Plan (3), with the challenging goal of balancing patient safety with innovation, the spring and summer of 2019 brought several US congres…
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Tools and Processes for Mature and Emerging Therapies
New technologies and thought trends provide innovative biomanufacturing approaches for a range of therapies.
By Rita Peters
Conference sessions and new technology introductions at recent t…
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Jefferson Institute for Bioprocessing Opens Near Philadelphia, PA
Through the 25,000-ft2 flexible facility at Spring House Innovation Park in Lower Gwynedd, PA, JIB provides tactile training by combining interactive presentations, workshops, and hands-on laboratory …
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What’s New in Upstream Technologies
Recent upstream processing innovations include enhanced sensor technology, single-use bioreactors, and automated cell culture systems.
By Amber Lowry
SCIENCE PHOTO - STOCK.A…
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The Outlook for CMO Outsourcing in 2019
By Eric Langer and Ronald A. Rader
Biopharmaceutical industry-related indicators and trends are supporting continued incremental increases in outsourcing of pre- and commercial AP…
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Scaling Up Novel Therapies
For example, a new collaboration (1) that involves Cytiva, Cobra Biologics, and UK’s Center for Process Innovation, is working on new ways to use fiber-based chromatography to improve AAV scale-up. Ot…
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FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
More consistent and reliable production processes are critical for advancing innovative treatments.
By Jill Wechsler
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Optimizing Late-Stage and Commercial Cell-Culture Processes
Cell-culture process innovations include platform processes with high productivity and chemically defined culture media, which have helped to reduce process variability and complexity, improve efficie…
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Techniques for Improving Process Development for Exosome-Derived Therapeutics
Here, the Process Development Forum speaks with Aaron Noyes, Head of Downstream Processing, at Codiak BioSciences about exosomes, their potential clinical applications, and process innovations that wo…
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Transformative Medicines Challenge FDA and Manufacturers
Transformative Medicines Challenge FDA and Manufacturers
New gene therapies and combination products require innovative regulatory approaches.
By Jill Wechsler …