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Top Stories
Through its life-sciences business, MilliporeSigma, Merck KGaA will collaborate with Baylor College of Medicine to advance vaccine development for neglected and emerging diseases.
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Pfizer will invest $100 million to expand its manufacturing facilities in Sanford, North Carolina.
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TOP COUNTRY FOR PHARMA?
What Country Ranks Highest in Pharma Manufacturing?
CPhI survey seeks industry input to rank top-performing nations on pharma manufacturing and business factors.
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Industry News
A pilot program will offer instruction on scientific and regulatory guidelines including training on GMPs and quality.
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Efforts to establish an international system for identifying and tracing drugs through the global supply chain are moving forward.
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Supplier News
Cambrex is investing $24 Million in new, highly potent API manufacturing capacity at its Charles City, Iowa site.
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Lonza further expands its micronization services with the acquisition of Swiss contract manufacturer, Micro-Macinazione, following its previous $5.5-billion acquisition of dosage form provider, Capsugel.
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Changing the functional role of capsules in drug delivery
By combining polymer science, engineering and formulation know-how, we are creating breakthroughs in capsule and encapsulation technologies that are changing the functional role of capsules in medical research, drug formulation and drug delivery. Capsugel provides leading-edge solutions that protect high value compounds, optimize delivery to targeted sites in the body, and ensure the best operational performance in capsule filling. To learn more, visit  www.capsugel.com. |
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Bio/Pharma News
Upon merging, the combined company will be named SELLAS Life Science Group and will focus on cancer treatments with a late-stage pipeline featuring immunotherapies targeting hematology and solid tumors.
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FDA requests more detailed information on a post-marketing study for Dynavax's hep-B vaccine, which will require an extended review time past its August 2017 PDUFA date.
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Regulatory News
The agency sent a warning letter to Cellex-C International regarding GMP violations found at the company's Toronto facility.
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FDA announced a voluntary recall of all liquid products manufactured by PharmaTech and distributed by Leader Brand, Major Pharmaceuticals and Rugby Laboratories because of possible Burkholderia cepacia (B. cepacia) contamination.
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Join Renishaw as we present a free day long symposium reviewing a variety of topics relevant to Raman in the Pharmaceutical Industry. Industry leaders from JEOL, Leica, Ondax, Linkam, and Renishaw will be presenting on the technology and techniques that impact the science of Raman today. The event takes place at Renishaw's Headquarters in West Dundee, IL on September 19.
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Quality
Characterization of the product and process is key for process development and scale-up of topical drug manufacturing using a QbD approach.
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Biologics
Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier.
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Manufacturing
Statistical methods and novel indices can be used to monitor and benchmark variability, and guide continuous improvement programs in late-stage drug development.
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Events
August 21–25, 2017
August 22–24, 2017
September 11–13, 2017
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REFERENCE BOOKS |
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A compilation of articles in a three-handbook set covering general Analytical Testing and Stability in the manufacture, packaging, storing, and testing of formulated products.
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eBOOKS
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New technologies, including single-use systems, are leading the push for faster production and higher titers. At the same time, ensuring quality in raw materials and water systems, and controlling contamination are paramount. In this Biologics and Sterile Manufacturing eBook, the editors explore key technology, process, and operational topics. |
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