PharmTech News

Jul 27, 2007
ePT--the Electronic Newsletter of Pharmaceutical Technology
Rapid microbial testing in biopharmaceutical manufacturing is an important tool in potentially reducing process risk and manufacturing costs due to loss of production material. Amy McDaniel, associate director of the QC Microbial Science and Technology Department with Wyeth Biotech, discussed the company’s evaluation and implementation of rapid microbial testing at Wyeth’s facility in Andover, Massachusetts, at the Pharmaceutical Technology Annual Conference.
Jul 27, 2007
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
The US Food and Drug Administration opened for public comment its Draft Guidance for Industry, ?Cooperative Manufacturing Arrangements for Licensed Biologics.?
Jul 27, 2007
ePT--the Electronic Newsletter of Pharmaceutical Technology
Moheb Nasr, director of the Office of New Drug Quality Assessment in the Center for Drug Evaluation and Research at the US Food and Drug Administration, addressed the agency’s history and progress in moving to a science- and risk-based approach in regulation at the Pharmaceutical Technology Annual Conference.
Jul 19, 2007
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
Beijing Med-Pharm acquires stake in Sunstone, JHP Pharmaceuticals buys King Pharmaceuticals facility, more
Jul 19, 2007
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
The US Food and Drug Administration announced the International Conference on Harmonization draft guidance Q10 Pharmaceutical Quality System in the Federal Register (Docket 2007D-0266, CDER 200783).
Jul 19, 2007
ePT--the Electronic Newsletter of Pharmaceutical Technology
Xcellerex, Inc. received two Phase-I contracts from the Defense Advanced Research Projects Agency (Arlington, VA) for the Accelerated Manufacture of Pharmaceuticals program.
Jul 19, 2007
ePT--the Electronic Newsletter of Pharmaceutical Technology
The IBM Corporation signed a $1.4-billion global outsourcing deal with AstraZeneca PLC (London). The seven-year agreement, which renews and expands on a current contract, covers the provision of IT infrastructure services to 60 countries and additional functions within AstraZeneca.
Jul 13, 2007
PTSM: Pharmaceutical Technology Sourcing and Management
Although North America accounts for the largest share of the pharmaceutical market, Brazil, China, India, Indonesia, Mexico, Russia, and Turkey are projected to account for almost one-fifth of the global market by 2020. The rising participation in select countries' drug-development activities is evident by recent investment and outsourcing by the pharmaceutical majors.
Jul 12, 2007
ePT--the Electronic Newsletter of Pharmaceutical Technology
A new guidance issued by the US Food and Drug Administration earlier this month advises companies on how to treat polymorphic drug compounds?those that exhibit multiple structural forms?in filing abbreviated new drug applications.
Jul 12, 2007
ePT--the Electronic Newsletter of Pharmaceutical Technology
The United States Pharmacopeia announced that its implementation period for the USP-National Formulary General Notices statement requiring all manufacturers to conform to recently revised residual solvent standards in General Chapter 467 has been extended from July 1, 2007 to July 1, 2008.
native1_300x100
lorem ipsum