Top Stories
Norman (Ned) Sharpless, director of the National Cancer Institute at the National Institutes of Health, will become FDA acting commissioner.
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The UK government has rejected the withdrawal deal again and now faces further uncertainty, despite rejections of a 'no-deal' scenario by ministers, as well as a high probability of Brexit delay.
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INTERPHEX 2019 KEYNOTE SERIES
At INTERPHEX 2019, experts discuss strategies for bringing continuous manufacturing to commercial scale. Plus, learn how 3D printing technology is being used in bio/pharma applications.
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Industry News
The FDA planned budget features added funds allotted to improved oversight of drugs, biologics, and medical devices.
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The company received $4.8 million from the Bill & Melinda Gates Foundation to accelerate global health research in the development of vaccines and antibody-based treatments for infectious diseases.
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Biopharma News
The companies will join forces to improve gene- and cell-therapy manufacturing using the cloud and machine learning.
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The acquisition of the site in Copenhagen, Denmark, will significantly expand Fujifilm's capacity and capabilities.
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Supplier News
Stream Bio entered into a new agreement with DBA Italia to launch Stream Bio's nanotech-based bioimaging probes in Italy.
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The collaboration's enhanced data exchange combined with advanced analytics are expected to reduce raw material variability and improve biomanufacturing performance reliability.
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Regulatory News
FDA sent a warning letter to Jubilant Life Sciences after investigators found CGMP violations.
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The agency published guidance to help with the development of enrichment strategist for clinical investigations of drug and biologic effectiveness.
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OUTSOURCING
Technology vendors are strengthening their positions in China as the nation emphasizes self-sufficiency in research, development, and manufacturing.
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NEW PRODUCTS AND SERVICES
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Tosoh Corporation is pleased to announce that its third production plant at its Nanyo Complex, in Shunan, Yamaguchi Prefecture for TOYOPEARL® and TSKgel® purification media will be at full operational capacity in April 2019.
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The DynaPro Plate Reader III from Wyatt Technology is an integrated instrument for automated, high-throughput characterization of size, molecular weight, aggregation, and stability of macromolecules and nanoparticles.
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TAKE THE SURVEY
Participate in BioPlan's 16th Annual Global Biopharmaceutical Manufacturing Study. Share your insight on current global and regional trends affecting biomanufacturing and receive a free aggregated summary of this year's results and an updated Top Trends in Biopharmaceutical Manufacturing White Paper. If you complete, the survey, BioPlan will donate $15 (up to $3000) on your behalf to global health charities or you can receive a $15 Amazon e-gift card.
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UPCOMING WEBCASTS
Direct Identification of Contaminant Particles on Lyophilization Cakes
Thursday, April 18, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Meaningful Analytics Data for Quick Decision Making in Development of Viral Vector-Based Therapies
Wednesday, April 10, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Sample Preparation and Analysis Workflows for Released N-Glycan Analysis of Biotherapeutics
Europe: Wednesday, March 27, 2019 at 3pm GMT | 4pm CET
North America: Wednesday, March 27, 2019 at 2pm EDT | 1pm CDT | 11am PDT
Asia-Pacific: Thursday, March 28, 2019 at 8:30am IST | 11am CST | 12pm JST
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March 17–21, 2019
March 18–21, 2019
April 2–4, 2019
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eBook
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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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