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Top Stories
The pharma major anticipates an annualized cost savings of roughly $500 million starting in 2018 based on a significant reduction in its global workforce.
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FDA cited Meridian Medical Technologies, a Pfizer company, which manufactures Mylan's EpiPen, for cGMP violations that included failure to appropriately investigate defects in auto-injector components.
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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
Scientists at Scripps' Florida campus showed for the first time that quality control steps exist in the production of proteins, which presents a target for anti-cancer drug development.
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BARDA has awarded Summit, a drug discovery and development company, a contract worth up to $62 million over five years for the development of a new small-molecule antibiotic.
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Supplier News
Predictive maintenance is one application planned for a new alliance that will bring Internet of Things capability to users of OSI's PI solution.
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The biopharmaceutical company broke ground on what will be a new 3000-ft2 addition to its Kansas biomanufacturing facility.
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Bio/Pharma News
Merck KGaA completes the divestment of its biosimilars business as part of its strategy to focus on developing a pipeline of innovator drugs.
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Roche's subsidiary, Genentech, issued the voluntary recall of the anti-stroke drug because of compromised vials containing sterile water that were packaged with the drug.
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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.
 Register today, space is limited.
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Regulatory News
The agency is looking for industry input on best practices for continuous manufacturing.
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The meeting, to be held jointly with the European Centre for Disease Prevention and Control, is part of the agency's effort to raise awareness about the threat of antimicrobial resistance.
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2017 PDA Container Closure, Devices and Delivery Systems: Compatibility and Material Safety Workshop ; Oct. 2-3, 2017 ; Washington, DC
New and innovative therapies are transforming the way primary packaging and device systems are viewed during development and throughout the product lifecycle. Differences in regulatory pathways for each component can impact the regulatory requirements and affect the time to market. The 2017 PDA Container Closure, Devices and Delivery Systems: Compatibility and Material Safety Workshop, will bring together industry leaders and regulators to examine the issues associated with compatibility and safety of drug device and delivery systems.
 Learn more |
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Outsourcing
Regulatory outsourcing can result in improved compliance, greater transparency, higher productivity, increased cost-effectiveness, and desired strategic outcomes.
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Standards/Regulations
EMA recognizes that a regulatory framework, under which medicines and diagnostics are developed and approved independently, may not be ideal.
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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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Drug Development
Pulmonary drug delivery is becoming increasingly used. When developing pulmonary drugs, pharmaceutical chemists must consider drug absorption, control of particle size, suitable toxicology models, and patient compliance.
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Scale Up/Tech Transfer
Continuous twin-screw granulation offers several options for increasing production scale. Thermo Fisher Scientific explains factors to consider in scale-up projects for manufacturing oral solid-dosage drugs.
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IVT's Validation Week celebrates its 23nd anniversary this year in Philadelphia! The industry's gold-standard for validation training is back to provide the most comprehensive information on new global regulations, technology advances and industry case models for developing, implementing and deploying validation procedures enterprise-wide. This year's program features customizable content for beginner and advanced professionals from bio/pharma and medical device fields.
 www.cbinet.com/valweek |
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AAPS 2017 Planning Guide
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Alcami is a world-class supplier of comprehensive pharmaceutical development and manufacturing services headquartered in Wilmington, NC.
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Catalent has broadened the scope of its OptiForm® Solution Suite platform to provide an efficient and seamless path from late-stage discovery to phase I clinical trials.
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Colorcon® is a world leader in the development, supply and technical support of formulated film coating systems, modified release technologies, and functional excipients for the pharmaceutical and nutritional industries.
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CordenPharma is your full-service Contract Development & Manufacturing (CDMO) partner for APIs, Drug Products, and Packaging Services.
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Events
September 19–21, 2017
September 25–29, 2017
September 26–28, 2017
more events |
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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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