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Top Stories
The directorate highlights achievements accomplished during the year of its 50th anniversary.
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Baxter announces that it will partner with Mayo Clinic and Velocity Pharmaceutical to form Vitesse Biologics.
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Achema 2015 Messe Frankfurt Halle 3, Stand A47
Weiler Engineering, Inc.'s corporate focus is to provide advanced aseptic liquid processing technology through application of customized ASEP-TECH® Blow/Fill/Seal machinery and services.
ASEP-TECH® Blow/Fill/Seal machines incorporate the three-step process of blow molding, aseptic filling, and hermetic sealing of liquid products in one compact machine frame.
Weiler is located in a 140,000 ft2 plant near Chicago O'Hare International Airport in the USA.
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Industry News
The draft guidance document clarifies chemistry, manufacturing, and controls information for marketing applications.
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BIO announces that for the second year in a row, it will feature the Innovation Zone at its 2015 conference in Philadelphia, PA.
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Supplier News
A new demonstration facility in New York gives Sartorius' customers hands-on access to bioprocessing systems and lab instruments.
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Excipient manufacturing site achieves EXCiPACT certification following regulatory inspections.
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Trends in Quality
Agreements & Communications: A CMO Perspective
Live Webcast: Tuesday, June 23, 2015 at 11:00 am EDT
This webinar, led by Milton Boyer, senior vice-president of drug product manufacturing at AMRI, will review and challenge the changing paradigms in the CMO¬/drug sponsor relationship. It is clear that both CMOs and drug sponsors are being held responsible for the actions of the other. Responsibilities once thought to be clearly defined are changing, with new guidance and expectations revealed in 483s and FDA warning letters.
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Bio/Pharma News
Teva announces the exclusive launch of its generic equivalent of Actonel in the US.
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Experts say that Adasuve has made an impact in the treatment of schizophrenia or bipolar I disorder.
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Controlling the Physical Properties and Performance of Semi-solid Formulations through Excipient Selection
Live Webinar: Wednesday, June 10, 2015 at 11 am EST
Are you developing new topical products to meet specific design criteria? Are you seeking to replicate the performance of a reference product? In either case, you can achieve your goals by intelligently employing your toolkit of excipients and exploiting knowledge of how they work on a fundamental level. BASF will introduce you to cases that demonstrate the functionality of their excipients and their use in solving problems or meeting design objectives.
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DRUG DELIVERY
Advances in transdermal drug delivery, particularly with microneedles, are enabling a wider range of drugs to be delivered through the skin.
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REGULATORY BEAT
The restructuring of the ICH, which is expected to begin in late 2015, could have a significant impact on the way pharmaceutical regulations are harmonized worldwide.
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OUTSOURCING
Biopharma companies on both sides of the Atlantic ship more of their assay testing to outside service providers.
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Solubility Enhancement
Solutions Using Predictive Analytics & Molecular Modeling
Live Webcast: Thursday, June 4, 2015 8:00 am PDT/ 10:00 am CDT/ 11:00 am EDT
Learn about a novel, systematic methodology to accelerate solubilization of poorly soluble molecules and speed formulation optimization and process development. Understand how molecular modeling can be used enhance the predictability of solubilization and overcome poor bioavailability.
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Webcasts
Wednesday, June 17, 2015, 2 pm EDT | 2 pm EDT | 11 am PDT
Join us for a discussion on the use of hydroxyapatite in mAb and mAb fragment purification processes.
Sponsored by: Tosoh Bioscience LLC
On Demand
The new ICH Q3D Guideline for Elemental Impurities has initiated reviews and changes in quality testing programs in bio/pharmaceutical companies around the world.
Sponsored by: SGS Life Science Services
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on pharmtech tv
Focus on Biobetters, Part 1
Feeding Powders in Pharmaceutical Processes
Reducing the Cost of Drug Manufacturing
FDA Applications and New Guidance Documents
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Events
June 08-10, 2015 | San Francisco, CA USA
June 15-18, 2015| Philadelphia, PA USA
July 16, 2015 | New Brunswick, NJ
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Practical Guidance for Successful Mammalian Cell Banking and Cell Line Characterization
On Demand
Join us for this informative webinar, presented by the team at Eurofins Lancaster Laboratories, to learn about the various aspects of cell banking and cell line characterization, including GMP production master and working cell banks, GMP non-production (e.g. bioassay) master and working cell banks, R&D cell banks or banking for end of production cells.
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REFERENCE BOOKS
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A compilation of articles Pharmaceutical Technology in a three-handbook set covering general analytical testing and stability in the manufacture, packaging, storing, and testing of formulated products. / Learn more /
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eBOOKS
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This eBook examines how advances in technology, equipment, excipients, analytical techniques, software, and manufacturing practices are facilitating the development, scale up, manufacturing, efficacy, and delivery of solid- and semi-solid dosage forms.
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