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Top Stories
Allergan entered into a licensing agreement with AstraZeneca for MEDI2070, an anti-IL-23 monoclonal antibody in phase IIB development for the treatment of patients with moderate-to-severe Crohn's disease.
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ViraTherapeutics will develop its VSV-GP therapy alone and in combination with other therapies.
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The time and resources required to finalize post-approval changes may be preventing manufacturers from modernizing facilities, or even scouting for new technology.
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EXPERT INTERVIEW
David Mayers, president of Wellspring Pharma Services sat down with Pharmaceutical Technology to discuss the manufacture of controlled substances.
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Industry News
The hospital received a five-year $5 million grant from CDC to survey for communicable diseases in children and evaluate vaccine effectiveness.
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The company is voluntarily recalling all unexpired lots of 50-mm, 0.2-micron filters.
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Bio/Pharma News
The new company will focus on R&D of cancer treatments.
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The Phase III trial examined guselkumab compared with a placebo and Humira at treating moderate-to-severe plaque psoriasis.
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Regulatory News
EDQM and the Japanese Pharmacopoeia will improve the sharing of information on therapeutic products that are common in both Europe and Japan.
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The guidance addresses the good manufacturing practice for managing quality in APIs.
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Download Your Free Pesticide Analysis Application Compendium
Learn how to run food and beverage applications across the entire pesticides analysis workflow with this comprehensive compendium containing essential information, from initial sample preparation to data processing. If you run or want to run pesticides analysis using liquid-, gas- or ion- chromatography-mass spectrometry, this compendium is for you.
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Natoli Engineering has added a new Basics of Tablet Manufacturing and Troubleshooting training course November 1 – 3. Designed specifically for tooling technicians, tablet press operators, tablet press maintenance technicians, QC/QA personnel, this training provides lectures and hand-on experiences in tablet design, tablet press setup and operation, steel types, tool rework and polishing, and more! Don’t miss the last opportunity of 2016!
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ASEPTIC/STERILE
PharmTech's 2016 survey shows general satisfaction with existing solid-dose and parenteral manufacturing equipment, and slow adoption of continuous manufacturing processes.
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AAPS Planning Guide
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Patheon is a leading global provider of pharmaceutical development and manufacturing services with approximately 8000 employees across 26 locations worldwide.
AAPS Booth # 1609
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Our Korsch XL 400 single- and multi-layer tablet technology ensures the highest regulatory standards quickly, flexibly, and reliably.
AAPS Booth # 1835
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Unither is a global development and manufacturing partner for proprietary and generic pharmaceutical dosage forms.
AAPS Booth # 1562
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UPCOMING WEBCASTS
Biocompatibility Testing of Combination Devices – New Regulatory Guidance
Live Webinar: Thursday, November 3, 2016 8 am PDT | 11 am EDT | 3 pm GMT | 4 pm CET
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Reversed Phase Liquid Chromatography using Surrogate/Additional Stationary Phases
Live Webinar: Wednesday, October 26, 2016 11:00 am EDT | 10:00 am CDT | 8:00 am PDT
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A Wireless Approach to Monitoring Systems in Complex, Regulated Environments
Live Webinar: Tuesday, October 25, 2016 2:00 pm EDT | 1:00 pm CDT | 11:00 am PDT
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Strategies for IND Filing Success
Live Webinar: Friday, October 21, 2016 11:00 am EDT | 10:00 am CDT | 8:00 am PDT
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Implementing On-Dose Anticounterfeiting Technologies for Solid-Dose Drug Products
Live Webinar: Friday, October 14, 2016 11:00 am EDT | 10:00 am CDT | 8:00 am PDT
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Don't Let Your Diluent be the Weakest Link in Your Drug Product
Live Webinar: Thursday, October 13, 2016 at 10:00 am EDT
Asia / Pacific Session: Thursday, October 13, 2016 at 3:00 pm SGT (Singapore)/ 4:00 pm JST (Tokyo/Korea)
US/EU Session: Thursday, October 13, 2016 at 10:00 am EDT (New York City)/ 3:00 pm BST (London)/ 4:00pm CEST (Berlin)
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Employing a Lean Lab Approach to Optimize Lab Processes: Part 2 “Improve Productivity”
Live Webinar: Tuesday October 11, 2016 11:00 am EDT | 3:00 pm GMT | 4:00 pm BST | 5:00 pm CET
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Events
November 7–8, 2016
November 13–17, 2016
November 16, 2016
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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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Read feature articles on accelerated scale-up for vaccine production, standards for air cleanliness classification, aseptic filling advances, a flexible approach to cleanroom design, a science-driven approach for microbial control, removing genotoxic impurities, regulatory enforcement, drug shortages, and validation of single-use shipping systems. |
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