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The Drug Development Process - From Discovery to Commercialization
August 15, 2012–August 17, 2012
King of Prussia, Pennsylvania
CPhI South America
August 21, 2012–August 23, 2012
San Paulo, Brazil
Pharmaceutical Regulatory Summit
August 21, 2012–August 24, 2012
San Francisco, California
Pharma Extractables & Leachables
August 22, 2012–August 23, 2012
Mumbai, India
cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices
August 27, 2012–August 29, 2012
Los Angeles, California 
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Pfizer Settles with DOJ and SEC on Improper Conduct in Select Emerging Markets
Pfizer has resolved with the US Department of Justice (DOJ) and Securities and Exchange Commission (SEC) matters related to certain improper payments in the operations of two of its subsidiaries outside the United States.
Gilead Partners with Indian Manufacturers on HIV Medicines
Gilead Sciences announced that it is entering into agreements with Mylan Laboratories, Ranbaxy Laboratories, and Strides Arcolab to enhance access in developing countries to generic versions of its anti-HIV medicine, emtricitabine.
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Whether it's tracking incoming customer complaints, identifying nonconforming materials from production, or using CAPA to correct events within the system, 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 to identify critical events, mitigate the risk, and prevent re-occurrence of these events.  Read More |
EMA Phases out Follow-Up Measures
The European Medicines Agency will soon be phasing out follow-up measures to marketing authorizations in place of a new system of classification that will be introduced in a stepwise manner.
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Ropack provides solid dose packaging services to leading pharmaceutical and healthcare companies. Operating in 250,000 square feet, Ropack is equipped for humidity- and temperature-sensitive production and packaging of stick-packs. Other services include blister, bottle and pouch, powder blending and encapsulation and in-country clinical trial packaging and distribution management. Ropack has the capacity, technology and resources to grow your business. Contact:paul.dupont@ropack.com
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Novartis in Cancer Collaboration with University of Pennsylvania
Novartis has entered into a global collaboration with the University of Pennsylvania in the US to research, develop, and commercialize targeted cancer therapies.
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 Sterilizing-grade filter improves biopharmaceutical manufacturing efficiency
Sartorius Stedim Biotech's (SSB) Sartopore Platinum sterilizing-grade filter for biopharmaceutical manufacturing improves product yields and filtration performance. The surface of the polyethersulfone filter membrane has been modified using a hydrophilic, thermostable polymer. This surface modification increases wetting properties, which reduces the amount of water for injection needed to wet the cartridge, and minimizes protein binding, which increases product yield. The membrane has been pleated using SSB's newly developed, proprietary TwinPleat process. The alternating long and short pleats of the membrane increase the filter area of a 10 in. cartridge by more than 60%. At the same time, this geometry ensures that liquids flow through the entire filter area so that the filtration capacity of the cartridge is used to the fullest extent, which improves filtration performance and lower filtration costs. The filter cartridges can be dry-steam sterilized in the forward or the reverse direction without altering the properties of their membrane. The filters can be used in the entire pH range from 1 to 14.
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Boehringer Ingelheim has entered into an agreement with Servier and its partner Xoma to transfer Xoma’s technology and process for the commercial manufacture of gevokizumab, Xoma’s novel interleukin 1-beta (IL-1β) allosteric modulating antibody for treating noninfectious uveitis. Upon completion of the transfer and the establishment of biological comparability, Boehringer Ingelheim is expected to produce gevokizumab at its facility in Biberach, Germany, for Servier’s commercial use. Additionally, Servier and Xoma will retain all rights to the development and commercialization of gevokizumab. Read More
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Realize Effective Pharmaceuticals
Reliable solutions enable pharmaceutical scientists to innovate in disease research, accelerate drug discovery and have greater confidence throughout development and manufacturing. Agilent solutions in genomics research, automation, separation and detection technologies along with workflow driven software solutions helps deliver the answers to bring effective therapeutics to market.
Learn more at  www.agilent.com/lifesciences/realizepharma |
Gallus BioPharmaceuticals has signed a pact with
Theorem Clinical Research to provide process development and clinical and commercial supply for mammalian cell-based biopharmaceutical products to Theorem’s customers. In return, Theorem will provide Gallus’ customers with contract research services. The purpose of the agreement is to increase the global reach of both companies and to support customers in the research, manufacture, and commercialization of biopharmaceuticals. Read More
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Maximize GC Headspace Productivity
Develop reliable testing for residual solvents with the Agilent 7697A Headspace Sampler injection system and maximize your precision, accuracy and throughput. Agilent’s method translation tools allow for conversion from other headspace samplers to deliver unparalleled confidence in your analytical results. See the animated demo |
Teva Canada has completed the sale of Teva’s Mirabel (Montreal, Quebec) manufacturing facility to the CDMO Halo Pharmaceutical on July, 31, 2012. Under the terms of the sale, Teva Canada and Halo have established manufacturing agreements. Halo will continue to manufacture all products currently produced at the Mirabel site until the end of 2012. Afterwards, manufacturing operations will be transferred to Teva’s Stouffville, Ontario, facility. Read More
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Powders: Their Properties and Processing
September 10-12 Boca Raton, FL. Use Priority Code PT200 and Save $200 on tuition.
Join CfPA for review of various properties of powdered solids pertinent to the development and manufacture of products in the pharmaceutical & cosmetic industries. Get the latest on experimental techniques and equipment for evaluating important properties in relation to the underlying principles and common industrial problems.  Read More |
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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Be part of CPhI South America, the leading pharma ingredients event in Sao Paulo, Brazil 21-23 August.
At CPhI South America you will join 3,500 pharma professionals from around the world looking for partners and business opportunities in the rapidly growing Latin American market. Senior pharma professionals attend to meet suppliers and new partners to drive business the rest of the year.  Read More |
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Recent USP Changes: Regulatory and Quality Aspects of Sample Preparation
Live Webcast: Tuesday, September 18 2012 at 11:00 AM EDT
Register Free at  www.pharmtech.com/sampleprep |
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to ptpress@advanstar.com |
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| 35th Anniversary Special: Advances in Protein Expression |
by: Amy Ritter
Improvements in expression platforms and enhanced tools for selecting clones are among the advances of the past few decades.
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Coming soon: Pharm Tech’s September issue will delve into analytical and laboratory testing for biopharmaceuticals. |
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Know Before You Go—2012 Conference Previews
Visit our Show & Exhibition Gateway 2012 to see which companies are exhibiting at upcoming industry conferences.
Find company backgrounds, new product releases, booth materials, and more.
PharmTech's online
Gateway is your guide to the season's leading shows.
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