Top Stories
FDA Commissioner Gottlieb expects that the saline and amino acid drug shortages from Puerto Rican manufacturing facilities will improve in the early part of 2018.
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Roche has agreed to acquire Ignyta, an oncology company specializing in precision medicines, in an all-cash transaction valued at $1.7 billion.
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Industry News
The company is voluntarily recalling product because of glass particles found in vials.
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The IFPAC annual meeting on advancing the understanding and control of manufacturing processes using process analytical technology will be held Feb. 11-14, 2018.
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Biopharma News
The companies aim to discover and develop locked nucleic acid oligonucleotides as orally available therapies for treating inflammatory bowel diseases.
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The companies aim to develop a potential zinc finger protein transcription factor-based gene therapy for treating Lou Gehrig’s disease.
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Supplier News
The contract manufacturing company has completed construction on a new aseptic fill/finish facility in Wuxi, China.
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The companies will collaborate on the development of vaccines to expand GeoVax’s cancer immunotherapy program.
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Regulatory News
The agency published draft guidance on good practices for submitting abbreviated new drug applications.
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FDA noted in a recent inspection that American CryoStem was receiving and processing adipose tissue into a product called Atcell, and then marketing the product without agency approval.
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FEATURED TOPICS
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MANUFACTURING
Small-molecule therapeutics can also benefit from the implementation of PAT in the manufacturing process.
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BUSINESS TRENDS
The Biomanufacturing Technology Roadmap is accelerating innovative manufacturing strategies for biopharmaceuticals.
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SUPPLY CHAIN/LOGISTICS
Cross-functional reliability rooms identify risk and planning metrics, provide insights for production forecasts, and predict trends and areas for improvement.
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REGULATORY/GMP COMPLIANCE
SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
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Events
February 7–8, 2018
February 11–14, 2018
March 12–14, 2018
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eBook
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Vaccines—from childhood and influenza immunizations, to epidemic prevention, to cancer and therapeutic treatments—present unique development challenges. In this Vaccine and Manufacturing eBook, the editors explore development and manufacturing options to make vaccines more accessible.
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