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Top Stories
Pfizer creates separate business units for innovator medicines, generic drugs, and consumer products.
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FDA is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.
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Industry News
Report predicts PAT, NIRS, continuous bioprocessing, and a 'technological arms race' could improve biopharma manufacturing efficiencies.
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Annual awards program recognizes innovation in bio/pharma drug development and manufacturing.
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Biopharma News
Teva Pharmaceuticals USA will move its US headquarters to Parsippany-Troy Hills, NJ.
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The pharma major intends to spinoff Alcon as a stand-alone eye-care devices company.
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Supplier News
The expansion at the company's Gillingham, UK, site, worth EUR 9 million (approximately US$10.5 million), will improve the company's distribution capabilities.
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Catalent Biologics will adopt Berkeley Lights' Beacon optofluidic platform for its cell-line development workflow.
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Regulatory News
Findings from a survey show that some companies have not yet taken the necessary steps to ensure the continuity of medicine supply in the European Union after the United Kingdom's departure.
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Teva Pharmaceuticals, Major Pharmaceuticals, and Solco Healthcare are voluntarily recalling their products containing valsartan because of the presence of N-nitrosodimethylamine.
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Data Integrity:
With FDA attention pinpointed on data integrity in recent 483s and warning letters, it is critical to arm yourself with the tools and resources to ensure data integrity in manufacturing processes. IVT's 4th Annual Data Integrity Validation provides a variety of industry perspectives in an unmatched training environment, diving deep into the nuances of building and maintaining a compliant data governance program across company-wide systems.  www.cbinet.com/dataintegrity
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EXCIPIENTS
There is a lot of interest in delivering biologics via non-invasive routes in attempt to improve patient compliance and convenience.
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QUALITY SYSTEMS
Focusing on whether the product meets its defined quality attributes should help one make reasonable, documentable, and defendable risk-based decisions, according to Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
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Events
August 13–14, 2018
August 15–16, 2018
August 21–23, 2018
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A review of new technologies and processes that are helping to drive the adoption of single-use systems for the commercial production of biologic-based drugs.
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