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Top Stories
The $62-billion acquisition of Shire by Takeda Pharmaceutical was approved by both sets of shareholders.
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FDA cites Zhejiang Huahai Pharmaceutical in valsartan impurity investigation.
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Industry News
AqVida, winner of the 2018 CPhI Excellence in Pharma Award for manufacturing technology and equipment, identifies advantages of robotics compared to conventional automation in fill/finish operations.
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The UK's government has revealed the details of the second Life Sciences sector deal, forming part of the Industrial Strategy.
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Go beyond lecture learning with PDA’s industry-recognized Aseptic Processing training course. In this popular two-week training course, you will receive more than 50 hours of hands-on training from leading industry experts on how to properly evaluate and improve your company’s aseptic processes. Participate in the most comprehensive aseptic training available to equip yourself with tools and experience you can apply immediately on the job.
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Supplier News
The company will use GE Healthcare’s off-the-shelf KUBio biologics factory, which is expected to start operations in 2020, to provide development and manufacturing for early- to late-clinical and early-commercial manufacturing stages.
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The company is investing approximately $14 million to expand biologics packaging capabilities and capacity at its biologics manufacturing facility in Bloomington, IN.
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Bio/Pharma News
GSK and TESARO have entered into a definitive agreement concerning GSK's acquisition of TESARO for an aggregate cash consideration worth approximately $5.1 billion.
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The companies aim to advance research into inflammatory bowel disease.
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View Eurofins Lancaster Laboratories’ Microbiology virtual tour to see why our compliance, consulting and capacity are critical to ensuring the tiniest contamination does not become a big deal. We offer personalized study designs, the highest standard of data integrity, and largest scope of Micro Testing solutions to get it done on time and right the first time.
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Regulatory News
New FDA guidance developed to identify lapses in data integrity and promote best practices.
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ANALYTICAL INSTRUMENTATION
If a vortex mixer produces too much energy during sample preparation for particle size analysis, the size and morphology of particles can change. A study compares the applied shear to sample suspensions of ibuprofen to observe the effects of applied shear on the particle size distribution..
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MANUFACTURING
By reducing the number of assays needed and allowing product quality attributes to be measured end to end, MAM promises to allow users to gain product and process understanding much sooner than they could in the past, and to ensure quality and safety in a more efficient, streamlined way, throughout the product life cycle.
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OUTSOURCING
As biopharma companies rapidly change their focus, they may lack the laboratory space, instrumentation, and the scientific knowledge to support biologics research.
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QUALITY BY DESIGN
This article discusses why it is important to apply risk analysis, QbD, and DoE in the development of analytical methods.
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January 24, 2019
March 3–6, 2019
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The editors explore new tools for bio/pharma lab studies—such as robotics, augmented reality, and advanced instrumentation— as well as best practices for method development, multiple attribute monitoring, lab mixers, and raw material testing. |
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