Top Stories
Thirty percent of current Remicade patients could be eligible for a switch to competitors such as Inflectra, according to estimates, although J&J doubts this will occur in the United States in 2016.
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The vaccine candidate has also won a Priority Medicines (PRIME) status from EMA.
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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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Pesticide Explorer Collection
The Thermo Scientific™ Pesticide Explorer Collection is a comprehensive set of LC-MS solutions designed for laboratories performing routine quantitation, targeted and non-targeted screening of pesticide residues in food matrices.
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Industry News
A new website collects and rates information about life-science supplies from academic journals to simplify researcher purchasing decisions.
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The conference will return to the COEX center in Seoul for the third year from August 23-25, 2016.
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Natoli Engineering's Press Set-Up Tool Boxes contain everything you need to properly set up a tablet press easily and quickly. Each heavy-duty toolbox comes fully customized with all the necessary tools and accessories for your specific press model. Order by machine type and number of stations. Available for special or modified tablet presses.
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Supplier News
The pen injectors will be produced at Catalent's Brussels, Belgium facility.
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The company announced that it will be relaunching its customer collaboration centers.
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Bio/Pharma News
Generic versions of AstraZeneca's blockbuster Crestor will hit the US market after a federal judge refused to issue a restraining order blocking the approval of rosuvastatin ANDAs.
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The companies filed a BLA for romosozumab, an investigational monoclonal antibody for the treatment of osteoporosis.
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New Trends in Hygienic Diaphragm Valves that Improve Reliability
LIVE WEBCAST: Thursday, September 22, 2016 at 11:00 am EDT
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Regulatory News
The company manufactures biological drug products and intermediates for the allergy vaccine market.
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Sustained-Release Formulation: Overcoming Key Challenges Like Alcohol-Induced Dose Dumping
LIVE WEBCAST: Tuesday, September 13, 2016 at 11 am EDT | 10 am CDT | 8 am PDT
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FACILITIES
Integrating quality and compliance with technology transfer and careful project management are key in starting up a facility and launching a biologic drug.
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SUPPLY CHAIN
Data integrity and cGMP issues demand closer scrutiny of suppliers. Bribery and corruption may become the next supply chain flashpoint.
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Understanding the Relationship between Critical Quality Attributes and the Microstructure of Topical Semi-Solid Formulations
LIVE WEBCAST: Tuesday, September 8, 2016 at 11 am EDT | 10 am CDT | 8 am PDT
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GMPs
China and India are also increasing inspections and becoming more exigent about data integrity and cGMPs.
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PACKAGING
Innovations protect product quality, improve productivity, enhance sustainability, and simplify usage for patients and caregivers.
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The Advantages of a Employing a Lipid-Based Formulation Process in Early Development
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Webcasts
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When lab workloads seem too high to handle, analysis results or approvals are late, or lead times are exceeded, it is time to take a closer look at a lean lab approach, especially before investing in new resources such as equipment, premises, or personnel.
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In this 60-minute webcast, experts will explain the concept of water activity and its relationship to the growth of microorganisms. Key regulatory guidance and compendial documents will be reviewed.
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Bio/Pharma in China
New Initiatives, New Opportunities
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Events
August 10-11, 2016
August 17-18, 2016
September 12-14, 2016
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REFERENCE BOOKS |
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A compilation of informative, useful articles designed to help you meet the challenges of process analytical technology, be more efficient in testing, reduce over-processing, enhance consistency, and minimize rejects.
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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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