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Top Stories
The new center will integrate biologics drug discovery, development, clinical manufacturing, and commercial manufacturing.
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GE's new facility, which will be operational in 2019, will produce a fiber-based chromatography platform for more efficient biopharmaceutical purification.
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Industry News
The partnership, co-funded by Enterprise Ireland, will develop technologies for monitoring the quality of biopharma processes.
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The University of South Australia is working to develop needle-free vaccines for Zika, chikingunya, and peanut allergy in a collaboration with Australian biotechnology company Sementis and Enesi Pharma, a United Kingdom-based pharmaceutical company.
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Biopharma News
The vaccine producer announced an expansion to its Holly Springs, NC, manufacturing facility where it will increase production of its cell-based quadrivalent influenza vaccine.
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The acquisition will give Genentech full rights to Jecure's preclinical portfolio of NLRP3 inhibitors.
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Process Development Forum
Need to optimize your manufacturing systems? Find insights, solutions, and shortcuts in bioprocessing at ProcessDevelopmentForum.com
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Supplier News
The contract research organization has increased its US-based early phase clinical capacity and doubled its specialty lab space.
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Cobra, Pall, and Cell and Gene Therapy Catapult are collaborating to develop continuous manufacturing for gene therapy production.
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Regulatory News
Despite ongoing efforts to address the problem, FDA now sees a rise in active shortages and in the duration of supply problems.
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FEATURE TOPICS |
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DRUG DELIVERY
As biologic drugs grow increasingly complex, drug delivery mechanisms such as prefilled syringes are being adapted to meet the challenges.
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UPSTREAM PROCESSING
This article will explore the requirements for media and supplements needed to maintain newer cell lines, such as those based on human cells and fungal cells.
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FACILITIES
Advanced therapy medicinal products pose unique manufacturing challenges that will require appropriate and thoughtful facility design and equipment.
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MANUFACTURING
The second half of this article describes the testing methods used by the authors to demonstrate the applicability of single-use mixing technology for virus inactivation.
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December 10–12, 2018
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This eBook covers method development, analytical techniques, and profiles of new instruments, equipment, and supplies used in the testing and analysis of raw materials, drug substances, and drug products.
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