Top Stories
Supply chain players are eligible to participate in FDA's pilot program to develop an electronic system for tracking drug products.
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The companies will jointly develop and commercialize an investigational bifunctional fusion protein immunotherapy currently in clinical development for cancer treatment.
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Industry News
PDA survey and conference discussion will generate information to guidance on technology transfer.
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Researchers have created a virtual library expected to expand the availability of "make-on-demand" molecules for drug discovery.
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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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Supplier News
PCI Pharma Services expanded capacity of its commercial packaging site in Illinois.
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Nine award winners from the 2019 edition of Pharmapack Europe, covering innovations across drug delivery, packaging, and materials and components, have been announced.
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Bio/Pharma News
In a deal potentially worth up to $460 million, Genentech and Xencor will develop and commercialize novel cytokine therapeutics.
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The strategic partnership is expected to bring a new source of supply to providers, alleviating in particular the two-year shortage of metoprolol injection.
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Exclusive Interview from AAPS
Developing New Technologies in Controlled Release
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Exclusive Interview from AAPS 2018
Cutting Edge Formulations in Topic Drug Development
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Regulatory News
The US District Court for the Western District of Pennsylvania entered into a consent decree of permanent injunction against Ranier's Rx Laboratory Inc., a compounding facility.
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The US Pharmacopeial Convention's new plan will include new and revised quality standards and activities to support the development of new generic drugs.
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The 2019 PDA Annual Meeting provides a venue for obtaining the latest and most comprehensive information on a broad range of topics related to pharmaceutical processing, manufacturing, supply chain, and quality control. Take part in plenary sessions, concurrent tracks, topic-specific Interest Group sessions, an exhibition, and networking opportunities to learn about and share knowledge on innovative manufacturing strategies, disruptive technologies, and rapid drug development.
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ANALYTICS
Spectroscopic-based control methods were introduced as equivalent alternative methods, first to a gas chromatographic method to monitor an in-process solvent exchange step and second to a potentiometric titration method to release a process input material for drug substance manufacturing.
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DRUG DEVELOPMENT
Using a QbD approach in the development and formulation of topical products will enable the drug developer to provide a robust control strategy for manufacturing.
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OUTSOURCING
Radha Iyer, vice-president and head of Quality and Scientific Affairs, Global Developed Markets, Dr. Reddy's Laboratories, discusses new initiatives at the company.
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SUPPLY CHAIN
Recent advancements in cold-chain technology offer improved transporting and storing of temperature-sensitive pharmaceutical products.
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Events
March 3–6, 2019
March 11–13, 2019
March 17–21, 2019
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eBOOKS
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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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