Search results for "innovation"
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Updating Viral Clearance for New Biologic Modalities
Next-gen biopharma processing
Recent innovations, particularly in filter membranes and chromatography resins, have further helped to improve viral clearance performance.
“In general, chromatog…
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Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
Other innovations include single-use sensors such as the Rosemount 550pH sensor from Emerson and Internet of Things (IoT) enabled devices. IoT enabled devices can provide automated preventive maintena…
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Biosimilar Quality Requirements
Congress created an approval pathway in the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) for biological products that are demonstrated to be “biosimilar” to or “interchangeable” w…
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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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