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Top Stories
An advisory panel deemed Amgen's Repatha (evolocumab) to be safe overall.
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An FDA advisory panel voted 13-3 in favor of approval of Sanofi and Regeneron Pharmaceuticals' cholesterol-homeostasis therapy Praluent (alirocumab).
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Industry News
With drug development trends shifting towards personalized medicines, new technologies are needed for the manufacture of these highly sensitive drug products.
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CPhI Worldwide announces five new categories for the 2015 CPhIPharma Awards.
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Supplier News
West Pharmaceutical began construction on its component manufacturing facility located in Waterford, Ireland.
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A new GMP facility in Massachusetts will produce enzymes and other reagents for in-vitro diagnostics.
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Bio/Pharma News
At BIO 2015, CQDM and MaRS Innovation announced an investment in Encycle Therapeutics to research chemical properties needed to make peptide-like molecules orally bioavailable.
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The exclusive manufacturing collaboration will establish production for adeno-associated virus gene-therapy treatments incorporating REGENXBIO’s NAV Technology.
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Ion exchange resins have long been in the formulator's toolkit, but only recently has there been an increased interest in their use as excipients. Dow AMBERLITE™ and DUOLITE™ ion exchange resins have a broad range of applications, including taste masking, tablet disintegration, modified release, and the formulation of poorly soluble or unstable drug compounds.
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MANUFACTURING
Clearly defined zones of cleanliness must be designed and maintained to prevent product contamination.
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E-Book: Bioprocessing and Sterile Manufacturing
The editors examine novel technologies for the development, manufacture, purification, and delivery of small- and large-molecule drugs, including single-use systems, lyophilization, andmicrobial monitoring. Aging facilities and the future of aseptic processing are featured topics.
 Click here for your FREE download! |
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Webcasts
Tuesday, June 23, 2015, 15:00 CEST for Europe and June 30, 2015, 11:00am EDT for North America
Learn about adaptive clinical trials, patient recruitment strategies, and advanced biomarker analysis tools designed that can accelerate drug development and clinical testing processes.
Sponsored by: SGS
Wednesday, June 24, 2015, 09:00 AM EDT
Ion exchange resins have long been in the formulator's toolkit, but only recently have they been used as excipients. Learn the value and benefits ion exchange resins bring to drug formulation challenges such as taste masking, abuse deterrence, controlled release, and more.
Sponsored by: Dow
On Demand
Hear how CoreRx has successfully implemented a flexible automated powder dosing solution for capsule filling, in order to save time, increase accuracy and protect the safety of the scientists working with active pharmaceutical ingredients.
Sponsored by: Mettler Toledo
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Pharmaceutical Technology E-Book: Solid Dosage and Excipients
This e-book 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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on pharmtech tv
External Lubrication in Tablet Production
Trends and Concerns in Capsule Production
Focus on Biobetters, Part 2
Feeding Powders in Pharmaceutical Processes
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Events
July 16, 2015 | New Brunswick, NJ
July 22–25, 2015 | Barcelona, Spain
August 12–13, 2015 | Philadelphia, PA
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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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REFERENCE BOOKS
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This three-volume set of comprehensive pharmacology reference guides cover solid-dosage form principles such as oral solid-dosage forms, powders, mixing and blending, excipients, tableting, and coating. Stay current with compressed tablet manufacturing processes, solid dosage processing equipment, tablet-pressing processes, and pharmaceutical industry trends in oral solid dosage manufacturing and solid dosage form development. / Learn more /
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Solubility Enhancement
Solutions Using Predictive Analytics & Molecular Modeling
On Demand
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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eBOOKS
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The editors examine novel sterile and bioprocessing technologies including single-use systems, aging systems, cleanrooms, and lyophilization.
more ebooks
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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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