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2012 PDA Annual Meeting
April 16, 2012—April 18, 2012
Phoenix, Arizona
World Congress of Cardiology
April 18, 2012—April 21, 2012
Dubai, United Arab Emirates
10th EGA International Symposium on Biosimilar Medicines
April 19, 2012—April 20, 2012
London, United Kingdom
LogiPharma
April 24, 2012—April 26, 2012
Geneva, Switzerland
The Pharma Congress Production & Technology
April 24, 2012—April 25, 2012
Dusseldorf, Germany 
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 Bioprocessing hose features flexible design
Saint-Gobain’s Sani-Tech Ultra-HP hose is designed for the life-sciences market. Its USP Class VI-compliant hose materials include reinforced layers of Sani-Tech Ultra silicone bonded to an ultra-smooth PharmaFluor FEP inner liner to ensure optimal flow and ease of cleaning. This hose is lightweight and extremely flexible. Its applications include bioprocessing, load cells, and product transfer.
The Sani-Tech Ultra-HP hose is available in 12-ft. lengths, and is constructed with multiple layers of reinforced Sani-Tech Ultra platinum-cured silicone. It contains a smooth inner bore for improved cleaning and sanitization, a fluoropolymer liner to minimize the binding of biological materials, and high-purity materials with a low count of total organic carbons, extractables, and leachables. Additional features include a broad chemical resistance, a simple assembly procedure, and a temperature rating of –65 ºF (–54 ºC) to 350 ºF (177 ºC).
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Having defined quality management processes in place can improve quality, reduce legal liability and make compliance a competitive advantage. Learn best practices to using Risk Assessment in a Quality Management System, and how building a risk matrix will facilitate the decision making process.
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Quantitative Determination of Genotoxic Impurities Using Xevo TQD
Xevo TQD is the only integrated system in its class that enables simultaneous acquisition of high quality quantitative and qualitative data from the widest range of experiments.
This application note demonstrates a rapid, simple and powerful approach to genotoxic impurity identification at the Threshold of Toxicological Concern (TTC) using the Xevo TQD when used in a qualitative manner with the ASAP Probe and product ion confirmation (PIC).  Learn More…
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Amgen has agreed to acquire KAI Pharmaceuticals, a privately held pharmaceutical company. KAI's lead product candidate, KAI-4169, is being studied for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease who are on dialysis. Through this acquisition, Amgen will acquire worldwide rights, excluding Japan, to KAI-4169. Under the agreement, Amgen will pay $315 million in cash to acquire KAI, and provide a loan, prior to deal closing, to enable Phase III clinical development planning for KAI-4169. The transaction has been approved by the stockholders of KAI and by the board of directors of each company. Completion of the transaction is subject to customary closing conditions, including regulatory approvals. Following the completion of the transaction, KAI will become a wholly owned subsidiary of Amgen. Read More
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Single Use Molded Manifold Connections
Single use manifolds combine tubing with molded fittings to eliminate many barbed fitting connections and their leak potential. Available in silicone or AdvantaFlex® biopharmaceutical grade TPE. Validation and extractables test portfolios available, as well as validated sterility assurance. Request a connection sample or see it at the PDA Annual Meeting, booth 301, or Interphex, booth 3055.  Read More...
AdvantaPure® |
Catalent Pharma Solutions and BASF have formed a bioavailability collaboration under which the companies will combine their respective expertise to provide pharmaceutical customers with a range of solutions to address challenges with Class II and IV poorly bioavailable compounds. Read More
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Podcast -  Process Validation for Sterile Manufacturing
Join William (JR) Humbert, the Validation Manager at Cook Pharmica, as he discusses the 2011 FDA Guidance for the Industry, Process Validation: General Principles and Practices, and the impact the guidance has for biotechnology and pharmaceutical companies performing sterile manufacturing process validation. |
GE Healthcare has signed a worldwide supply and distribution agreement with Refine Technology, a manufacturer and supplier of filtration systems for use in biopharmaceutical manufacturing. Under the agreement, GE Healthcare will supply Refine Technology with its hollow-fiber filtration cartridges for use with Refine Technology's ATF system, a cell-retention device used in the manufacture of biopharmaceuticals to generate high concentrations of cells ready for further processing. Read More
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Making Sense of Excipient Performance for Quality by Design (QbD)
Live Webcast: Thursday, April 19, 2012 at 10:00 EST, 15:00 GMT, 16:00 CET, 20:30 IST.
Register Free at  http://www.pharmtech.com/excipient |
FDA decided that Teva Pharmaceuticals USA is sole first-to-file for both Orange Book patents listed for Provigil (modafinil) and therefore Teva's abbreviated new drug application alone is entitled to 180-day exclusivity. Cephalon launched generic Provigil on Mar. 29, 2012, and FDA has also decided that such launch triggered the exclusivity. However, Mylan Pharmaceuticals has filed suit against FDA in a US district court seeking to overturn FDA's decision. Read More–Teva, Read More–Mylan
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What's the matter with Sample Prep? - Novel approaches and solutions
Live Webcast: Tuesday, April 24, 2012 at 11:00 AM EDT
Register Free at  http://www.pharmtech.com/sample |
Industry Briefs:
A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers. Read More
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Pharmaceutical Technology Presents Bio/Pharmaceutical Manufacturing Outsourcing
Build Strategic Partnerships • Improve Technology Transfer • Mitigate Risk
July 24-25, 2012 Philadelphia, PA
In this focused, interactive forum, bio/pharmaceutical executives come together with contract manufacturing organizations to discuss strategies for effective operations, quality oversight and risk mitigation. Join your colleagues to hear the latest regulatory trends, learn best sourcing practices and identify business opportunities in the outsourcing arena.
Register by June19th at  www.cbinet.com/outsourcing and save $300 with priority code: AMS592 |
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to [email protected] |
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