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Achieving Raw Material Transparency in the Pharmaceutical / BioPharmaceutical Supply Chain (June 18) Sponsored by SAFC Risk Mitigation Strategies for API Manufacturing in Emerging Markets (June 19) Sponsored by Neuland Laboratories Trends in Safe Handling of Potent Compounds in Pharmaceutical Manufacturing Processes (On Demand) Sponsored by Patheon More Webcasts BIT's 4th Annual Global Congress of Catalysis - 2013 June 29-July 1, 2013 China Pharma Trials World Korea 2013 July 8-11, 2013 South Korea Advertisement: Pharmaceutical Technology presents its Analytical Testing Resource Guide combo A compilation of articles in a three handbook set covering general Analytical Testing as well as Stability in the manufacture, packaging, storing and testing of formulated products. Click here

June 13, 2013 PharmTech.com PRINT SUBSCRIBE DIGITAL SUBSCRIBE Using Model-Predictive Design in Solid-Dosage Manufacturing Processes Models and modeling software gain a foothold in solid-dosage manufacturing process design. A Lifecycle Approach to Process Validation A science- and risk-based approach to verify and demonstrate that a process operating within predefined specified parameters consistently produces material that meets all its critical quality attributes. Congress Considers Legislation to Secure Drug Supply Chain Bills to regulate drug compounding and establish a national track and trace system face political and policy differences. ISPE Study Reports on Root Causes for Drug Shortages ISPE study reveals quality systems of manufacturing as the leading cause of drug shortages. Elan Board Rejects Multibillion Takeover Bid from Royalty Pharma Elan urges its shareholders to reject bid in an upcoming meeting on June 17. FDA Issues Warning Letter to Baxter Healthcare FDA cites cGMP violations of finished pharmaceuticals at the company's facilities in Marion North Carolina and Jayuya, Puerto Rico. GlaxoSmithKline Acknowledges Misrepresentation in Scientific Article One employee is dismissed, another has resigned, and three others are put on administrative leave. Advertisement: Life Sciences Guidebook: Best Practices for FDA Compliance Solutions This guidebook provides you with a basic overview for selecting, implementing and using FDA Compliance and Quality Management solutions. Learn the importance of QMS, best practices for FDA Compliance and Quality systems, and tips and tricks for finding the solution best suited for your company.Read More FDA Discovers Microbial Contamination in Compound Pharmacy Products FDA Discovers Microbial Contamination in Compound Pharmacy Products. Advertisement: Ligand’s Captisol® platform technology is a patent protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Captisol® has enabled six FDA approved products, including Pfizer’s VFEND® IV and Onyx Pharmaceuticals’ KYPROLIS®. Please visit www.captisol.com. For licensing opportunities please contact Captisol Customer Service at (877) 575-5593. EMA Revises Biosimilars Guideline EMA’s revised guideline on biosimilars containing biotechnology-derived proteins is published for public consultation. Advertisement: Pharmas and consumer healthcare organizations can benefit from the increased product safety, compliance, cost-savings and marketability offered by stick-pack packaging of Rx and supplements. Read "Stick-pack Benefits for Pharmaceuticals and Nutraceuticals," a whitepaper by Ropack's Paul Dupont. Visit www.ropack.com to learn more about Ropack's $9M, 15,000-sq-ft facility dedicated to stick-pack packaging of temperature- and humidity-sensitive products. (513) 846-0921. [email protected]. USP Forms Elemental Impurities Advisory Group USP appoints regulatory experts to elemental impurities implementation advisory group. Advertisement: Support and Solutions from Agilent for Impurity Profiling: New Genotoxic Impurities Primer Agilent partners with Pharma for great results.  Download or request a hard copy of our new guide, Genotoxic Impurities in Pharmaceutical Products:  Regulations and Analysis, authored by Ludwig Huber.  The guide provides specific guidelines for genotoxic impurities and recommendations for implementation according to EMA and FDA guidelines. Get your Genotoxic Primer now AstraZeneca to Acquire Pearl Therapeutics Acquisition will strengthen AstraZeneca’s respiratory portfolio with a potential new treatment for chronic obstructive pulmonary disease. Pfizer Partners with CytomX for Antibody Drug Conjugates The multimillion-dollar deal focuses oncology. Janssen and Second Genome Partner on Microbiome Drug Discovery Agreement seeks to advance novel drug targets and focus on therapies for ulcerative colitis. Boehringer Ingelheim Plans Biopharmaceuticals Facility in China Facility will use mammalian cell-culture technology and be ready for operations by 2016. Advertisement: Risk-Mitigation Strategies for API Manufacturing in Emerging Markets Live Webcast: Wednesday, June 19, 2013 at 11:00 am–12:00 pm EDT. Register Free at:www.pharmtech.com/emerging

Outsourcing Trends for the Pharmaceutical and Biopharmaceutical Industries. The editors of Pharmaceutical Technology and Pharmaceutical Technology Europe are interested in gaining your feedback on trends for contract services for manufacturing, research, and related support. If you are from a pharmaceutical/biopharmaceutical company or contract service provider, please complete this brief confidential editorial survey. Contact Us Click here to contact editorial. Click here to contact sales.

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