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Top Stories
The agency announced that FDA scientists have developed candidate vaccine viruses that may be used to produce influenza vaccines.
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The transaction is set to be completed at the end of the first quarter of 2020.
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Meet today’s best practices in container closure integrity with top quality containment solutions from DWK Life Sciences. Choose from a variety of cap and liner combinations to suit your packaging application. Ask your DWK Life Sciences representative in for a special offer – discount prices and more!
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Industry News
Innoveix Pharmaceuticals, Inc. is voluntarily recalling all sterile compounded drug products due to a lack of assurance of sterility.
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Developer of software for drug discovery, Optibrium, has announced in an Oct. 10, 2019 press release the introduction of its Augmented Chemistry services, which incorporate artificial intelligence technologies to help guide drug discovery.
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Supplier News
On Wednesday Nov. 6, 2019, Gregor Deutschle and Dr. Nicolas Eon, both from Schott, will share insights into ready-to-use solutions for complex biotech drugs.
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MilliporeSigma will now be the first company to make acoustic technology available for cell therapy manufacturing.
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Attend the 2019 PDA Quality Week, December 9-13, featuring two Conferences and one Workshop, to hear from the FDA’s Dr. Woodcock, Author Thomas Stanton, and other noted regulatory and industry experts as they explore the theme of Mastering Risk Management for Organizational Success.
Register by October 25 and save up to $600!
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Bio/Pharma NewS
The collaboration aims to reduce “vein-to-vein” time for patients and to optimize manufacturing and supply operations.
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The companies will collaborate to identify and develop in-vivo genome editing therapeutic candidates for genetic diseases, including hemophilia.
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Regulatory News
The guidance describes an optional streamlined submission process for use of an investigational in vitro diagnostic in a clinical trial for oncology therapies.
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The guidance describes an optional streamlined submission process for use of an investigational in vitro diagnostic in a clinical trial for oncology therapies.
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ANALYTICS
In this article, experts discuss the fundamentals of dissolution testing and highlight the challenges that are surfacing as a result of the increasing numbers of poorly soluble molecules entering the development pipeline.
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FORMULATION
Lipid-based formulations provide a versatile solution to bioavailability issues, but a multi-disciplinary approach is needed to overcome limitations with poorly soluble compounds.
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QUALITY
Production and process controls, organization and personnel were the top problems found, while packaging and labelling citations increased in 2017 and 2018.
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UPCOMING WEBCASTS
Replacing Settle Plates with Active Air Sampling
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Renishaw has developed the Virsa Raman Analyser using its expertise in optical design and detector technologies. It combines the power of laboratory–grade Raman with the convenience of a transportable unit. Use Renishaw's latest high-performance Raman spectroscopy system, to take your spectroscopic analysis away from the confines of the laboratory microscope to new samples and environments.
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The editors explore novel technologies for the formulation, manufacture,
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