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Top Stories
FDA issues a statement on new policy and enforcement steps to ensure proper oversight of stem cell therapies and regenerative medicine in the wake of two incidents involving unauthorized stem-cell treatment activity.
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The acquisition of Protein Sciences, a vaccines biotechnology company, strengthens Sanofi’s influenza vaccines portfolio.
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TOP COUNTRY FOR PHARMA?
What Country Ranks Highest in Pharma Manufacturing?
CPhI survey seeks industry input to rank top-performing nations on pharma manufacturing and business factors.
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IVT’s Validation Week celebrates its 23nd anniversary this year in Philadelphia! The industry’s gold-standard for validation training is back to provide the most comprehensive information on new global regulations, technology advances and industry case models for developing, implementing and deploying validation procedures enterprise-wide. This year’s program features customizable content for beginner and advanced professionals from bio/pharma and medical device fields.
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Industry News
With £4.5 million (US$5.8 million) in funding, the consortium is tasked with developing a new automated continuous biologics purification unit to make biologic drug manufacturing more efficient.
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The company is voluntarily recalling the products because of potential contamination with Burkholderia cepacia.
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Supplier News
CDMO Micro-Sphere is investing CHF 21 million (approximately $21.63 million) into the expansion of its GMP manufacturing capabilities at its Swiss facility.
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AstraZeneca and Champions will develop new cohorts of patient-derived xenograft models to be used in oncology programs in breast and lung cancer as well as for use in other academic and industry applications.
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Join Renishaw as we present a free day long symposium reviewing a variety of topics relevant to Raman in the Pharmaceutical Industry. Industry leaders from JEOL, Leica, Ondax, Linkam, and Renishaw will be presenting on the technology and techniques that impact the science of Raman today. The event takes place at Renishaw’s Headquarters in West Dundee, IL on September 19.
 Register today, space is limited. |
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Bio/Pharma News
The first program of this collaboration will focus on the development of a candidate for severe acute pancreatitis.
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Xellia Pharmaceuticals completed the expansion of its laboratory services building at its Budapest manufacturing site.
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Regulatory News
FDA has signed a confidentiality commitment with the European Commission and the European Medicines Agency that allows FDA to share confidential information with EU regulations.
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High-priority issues requiring immediate attention leave little time for Congress to consider drug access proposals that have limited bipartisan support.
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Quality
FDA’s Emerging Technologies Team (ETT) team chair Sau Lee describes the reasons for the team and its structure.
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Outsourcing
Despite some progress, the industry is still in a wait-and-see mode regarding the administration, Congress, and FDA.
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Standards & Regulation
The review of batch records creates a story of the materials, manufacturing, and packaging involved in the production of bio/pharmaceuticals, according to Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
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Events
September 11–13, 2017
September 19–21, 2017
September 25–29, 2017
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REFERENCE BOOKS |
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Increase your knowledge of solid dosage technology and solid dose tablet manufacturing processes. These comprehensive pharmacology reference guides cover a variety of solid-dosage form principles such as oral solid-dosage forms, powders, mixing and blending, excipients, tableting, and coating. Drug delivery system manufacturing professionals can use the solid dosage manufacturing books to stay current with compressed tablet manufacturing processes, solid dosage processing equipment, tablet-pressing processes, and pharmaceutical industry trends in oral solid dosage manufacturing and solid dosage form development.
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eBOOKS
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New technologies, including single-use systems, are leading the push for faster production and higher titers. At the same time, ensuring quality in raw materials and water systems, and controlling contamination are paramount. In this Biologics and Sterile Manufacturing eBook, the editors explore key technology, process, and operational topics. |
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