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Top Stories
Catalent expands gene therapy capabilities with $1.2-billion acquisition of Paragon Bioservices.
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AbbVie grants Boehringer Ingelheim a non-exclusive license to its intellectual property for Humira (adalimumab) in the United States.
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Industry News
The agency updated its list of recommended influenza virus strains that manufacturers should include in vaccines for the autumn 2019 season.
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FDA is examining and updating its programs for overseeing global operations and international affairs.
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Supplier News
The company announced plans to construct a 1.3 million-ft2 integrated manufacturing center in Chengdu, China.
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Bio/Pharma News
The company is recalling the lots because of possible peanut flour contamination.
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The acquisition of GlaxoSmithKline's manufacturing site in Cork, Ireland, will expand Thermo Fisher Scientific's global footprint for complex API manufacturing.
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Regulatory News
The agency is warning these manufacturers that they are putting consumers at risk with substandard manufacturing practices.
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TraceLink will participate in the agency's Pilot Project Program under the Drug Supply Chain Security Act.
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Turn to PDA for all your continuing education needs. PDA offers a wide range of lab-based and lecture training courses: from quality culture assessment to aseptic processing, and from strategies to reduce human error to contamination control best practices. Find the training course that best suits your professional goals.
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ANALYTICS
In Karl Fischer analysis, sulfur trioxide can react with DMSO, invalidating test results. The authors evaluated different instruments and methods to minimize the impact on results.
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QUALITY SYSTEMS
We need to understand both sides when it comes to audits, says Siegfried Schmitt, PhD, vice-president, technical, PAREXEL Consulting.
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MANUFACTURING
Single-use technology is gaining ground in downstream bioprocessing, but challenges stall further adoption.
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Overcoming Challenges in Ophthalmic Drug Delivery Including Bioavailability and Sterility
Wednesday, June 19, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Impact of New FDA Guidance on Bioanalytical Testing on Drug Development
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Requirements for Fully-Integrated Service Offerings in a HPAPI and Cytotoxic Environment
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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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