Top Stories
The company received prequalification for its Prevenar 13 MDV, which allows global use of the vaccine by United Nations countries and agencies.
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FDA issued a warning letter to the Worthing, UK facility for cross contamination and microbial contamination cGMP violations.
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EXPERT INTERVIEW
Francis Flanagan, associate principal scientist at Merck, sat down with Pharmaceutical Technology to discuss using minitablets in pharmaceutical manufacturing.
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Natoli Institute's Basics of Tablet Manufacturing & Troubleshooting course, September 20-22, is designed specifically for tablet compression professionals: Tooling technicians, tablet press operators, tablet press maintenance technicians, QC/QA personnel — anyone who wants to better understand the tablet manufacture process. Through lectures and hands-on workshops led by top industry experts, attendees learn firsthand how to minimize downtime by troubleshooting compression problems.
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Industry News
This new method uses inter-alpha inhibitors to promote attachment and long-term growth in stem cells.
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A new study examines the oral delivery of protein drugs in plant cells and hypothesizes that the cold storage and transportation of biologics could someday be eliminated.
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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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Supplier News
The company invested in the MicroSeq Rapid Microbial Identification System from Applied Biosystems at its Illinois facility.
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The company invested $50 million in an expansion at its Charles City, Iowa facility.
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Bio/Pharma News
The antisense drug will be the first in the companies' joint development deal for medications to treat autoimmune disorders of the gastrointestinal tract.
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The collaboration will focus on the investigational candidate JTX-2011 and up to four other early-stage programs in immuno-oncology.
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Sustained-Release Formulation: Overcoming Key Challenges Like Alcohol-Induced Dose Dumping
LIVE WEBCAST: Tuesday, September 13, 2016 | 11 am EDT | 10 am CDT | 8 am PDT
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Regulatory News
The company is voluntarily recalling a docusate sodium solution distributed by Rugby Laboratories due to risk of contamination.
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Understanding the Relationship between Critical Quality Attributes and the Microstructure of Topical Semi-Solid Formulations
LIVE WEBCAST: Thursday, September 8, 2016 at 11 am EDT | 10 am CDT | 8 am PDT
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QA/QC
Early planning for the integration of clean-in-place systems for equipment cleaning is key.
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FORMULATION
Aseptic spray drying provides an alternative to lyophilization as an enabling stabilization technology for parenteral biologic formulations.
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The Advantages of a Employing a Lipid-Based Formulation Process in Early Development
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ASEPTIC/STERILE
FDA approved the Raplixa, the first spray-dried fibrin sealant, in May 2015 to help control bleeding in adults during surgery.
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Compliance is Key Solutions to Decrease the Likelihood of Receiving a Form 483
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Webcasts
On Demand
Considerations for preparing for the process transfer, ensuring equipment and materials consistency, and post-transfer activities will be discussed.
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On Demand
An understanding of the variable process parameters that have a significant impact on the final pharmaceutical product is necessary to successfully manage a hot-melt extrusion process when using twin-screw extrusion. Experts will discuss residence time, mechanical-energy consumption, and other critical parameters, as well as their effects on a scientific approach to process scale-up.
Sponsored by Thermo Fisher Scientific
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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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Increase your knowledge of solid dosage technology and solid dose tablet manufacturing processes. These comprehensive pharmacology reference guides cover a variety of solid-dosage form principles such as oral solid-dosage forms, powders, mixing and blending, excipients, tableting, and coating. Drug delivery system manufacturing professionals can use the solid dosage manufacturing books to 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.
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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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