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Top Stories
Paul Hudson, formerly CEO of Novartis Pharmaceuticals, has been tapped to succeed Olivier Brandicourt as CEO of Sanofi.
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The acquisition will boost Biogen’s gene-therapy pipeline with the addition of two mid- to late-stage clinical assets and preclinical programs.
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Industry News
Jefferson established the Jefferson Institute for Bioprocessing workforce training institute in collaboration with NIBRT using the GE Healthcare FlexFactory Platform to produce biopharmaceuticals.
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Two facilities owned by Pharmasol Corporation were cited for violations of current good manufacturing practices in an FDA warning letter.
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Supplier News
The $10-million investment will include a 500-L single-use perfusion bioreactor and seven patented downstream processing units.
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Tergus Pharma announced a partnership with Great Point Partners and construction of a new commercial manufacturing facility in North Carolina.
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Extractables & Leachables Symposium for Drugs and Devices
Join Eurofins BioPharma Product Testing for its Extractables & Leachables Symposium on September 19 in Boston, MA. Don’t miss this full day technical seminar with sessions from Biogen, Regeneron Pharmaceuticals, Safe Bridge Consulting, as well as the featured presenter, Dr. Desmond Hunt from the United States Pharmacopeia. Register for FREE and see why 72% of past attendees rated our event better than other E&L events.
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Bio/Pharma News
The current president of Novartis’ Advanced Accelerator Applications has been appointed as the new Novartis Pharmaceuticals president.
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ERS Genomics and Bioneer have revealed the signing of a license agreement for access to CRISPR/Cas9 genome editing technology intellectual property.
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Regulatory News
Kingston Pharma LLC received a warning letter after an FDA inspection found violations of current good manufacturing practices including inadequate quality control.
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The two countries have been included into the mutual recognition agreement between the European Union and the US FDA that recognizes facility inspections conducted in different territories.
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SUPPLY CHAIN
Suppliers address the complexity of supplying disposable components for single-use systems to the global biopharmaceutical manufacturing industry.
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MANUFACTURING
The highly customized nature of cell and gene therapy production means that manufacturing innovations for one therapy may not be easily transferable to others.
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BIOLOGIC DRUGS
This article presents some key differences between the US and European regulation of biosimilars, including naming conventions and pharmacovigilance of biosimilars, and the impact of biosimilars on commercialization and affordability of biotherapeutics.
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Events
June 18–20, 2019
September 10–11, 2019
September 16–18, 2019
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The editors explore novel technologies for the formulation, manufacture,
purification, and delivery of sterile small- and large-molecule drugs including single-use systems, facilities and equipment, contamination issues, and process analytics.
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