http://www.pharmtech.com/pharmtech A publication providing practical information on pharmaceutical manufacturing. Content focuses on applied R&D technology, process control and computer-integrated manufacturing, biotechnology and technical management. 2012-05-17T04:38:20Z http://www.pharmtech.com/pharmtech/Online+Only/Big-Pharma-Bands-with-Academia-in-23-Million-Deal/ArticleStandard/Article/detail/773522?ref=25 AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Janssen Pharmaceutica NV, Merck Serono, and Pfizer have pledged support of more than £14 million ($23 million) to a translational drug development project being run by the UK's Medical Research Council and the University of Dundee. 2012-05-17T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202012/773522null HTML http://www.pharmtech.com/pharmtech/Company+and+People+Notes/Week-of-May-14-2012-GSK-Agrees-to-Acquire-Cellzome/ArticleStandard/Article/detail/773703?ref=25 GSK Agrees to Acquire Cellzome; Patheon Restructures; and More. 2012-05-17T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202012/773703null HTML http://www.pharmtech.com/pharmtech/Industry-Briefs-May-14-2012/ArticleStandard/Article/detail/773702?ref=25 A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers. 2012-05-17T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202012/773702null HTML http://www.pharmtech.com/pharmtech/News/US-Senators-Probe-Links-Between-Opiod-Manufacturer/ArticleStandard/Article/detail/773794?ref=25 Senators Max Baucus (D-Mont.) and Chuck Grassley (R-Iowa) send letters to opoid manufacturers and pain groups asking them to disclose financial ties. 2012-05-16T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202012/773794null HTML http://www.pharmtech.com/pharmtech/Editor%27s+Picks/May-2012-Editors-Picks-Products-from-Koslow-Scient/ArticleStandard/Article/detail/772821?ref=25 PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the May 2012 edition from Koslow Scientific Company and Vaisala. 2012-05-16T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192012/772821null HTML http://www.pharmtech.com/pharmtech/News/ICH-Q11-Drug-Substance-Guideline-Has-Gained-Global/ArticleStandard/Article/detail/773775?ref=25 ICH Q11, the anticipated guideline from the International Conference on Harmonization, titled Development and Manufacture of Drug Substances, has achieved international consensus. Q11 has been one of the fastest guidelines to move through the ICH harmonization process. 2012-05-16T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202012/773775null HTML http://www.pharmtech.com/pharmtech/In+the+Mixer/Classifying-Rouge-Aids-in-Determining-Maintenance-/ArticleStandard/Article/detail/772967?ref=25 Properly identifying and classifying rouge, a form of surface corrosion that comes in many forms, is important in determining whether it may be affecting product quality and whether further actions are necessary. 2012-05-16T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192012/772967null HTML http://www.pharmtech.com/pharmtech/Nisso-America-Inc/ArticleStandard/Article/detail/773750?ref=25 Nisso America Inc. 2012-05-16T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202012/773750null PDF http://www.pharmtech.com/pharmtech/Production+Lines/Ongoing-Challenges-in-Continuous-Manufacturing/ArticleStandard/Article/detail/772973?ref=25 Advances in process analytical technology and in defining lots for release are key for enabling use of continuous processes in solid-dosage manufacturing. 2012-05-16T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192012/772973null HTML http://www.pharmtech.com/pharmtech/Troubleshooting/Reducing-Wet-Cake-Drying-Time/ArticleStandard/Article/detail/772813?ref=25 We are using a vacuum oven to dry our wet-cake intermediate. At 120 °C, it takes 26 hours on average to dry the material from 80% to 10% moisture. Can we shorten our drying time, possibly by agitating the product to improve heat transfer? 2012-05-16T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192012/772813null HTML http://www.pharmtech.com/pharmtech/News/CDER-Ombudsman-Releases-Annual-Report/ArticleStandard/Article/detail/773641?ref=25 The Center for Drug Evaluation and Research Ombudsman's office released its annual report detailing the common questions and complaints received by the office in 2011. A total of 461 inquiries was received, an increase of 11% from 2010. The majority of inquiries, 60%, originated from industry, with consumers accounting for 23%, healthcare providers 7%, FDA employees 5%, and other 5%. 2012-05-15T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202012/773641null HTML http://www.pharmtech.com/pharmtech/Shimadzu---TOC-Measurement-of-Samples-Per-USP-lt64/ArticleStandard/Article/detail/773610?ref=25 Shimadzu - TOC Measurement of Samples Per USP <643> 2012-05-15T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202012/773610null HTML http://www.pharmtech.com/pharmtech/News/GlaxoSmithKline-Moves-Forward-with-26-Billion-Offe/ArticleStandard/Article/detail/773423?ref=25 GlaxoSmithKline tenders offer of $13.00 per share in an unsolicited bid despite an earlier rejection by Human Genome Sciences. 2012-05-14T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202012/773423null HTML http://www.pharmtech.com/pharmtech/NSF-DBA---How-to-deliver-effective-pharmaceutical-/ArticleStandard/Article/detail/773189?ref=25 NSF-DBA - How to deliver effective pharmaceutical audits and self-inspections 2012-05-11T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192012/773189null HTML http://www.pharmtech.com/pharmtech/Company+and+People+Notes/Week-of-May-7-2012-Coherus-BioSciences-Daiichi-San/ArticleStandard/Article/detail/772596?ref=25 Coherus BioSciences, Daiichi Sankyo Form Biosimilar Pact; Sandoz Agrees to Acquire Fougera Pharmaceuticals; and More. 2012-05-10T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192012/772596null HTML http://www.pharmtech.com/pharmtech/News/EFPIA-Advances-Medicines-Verification-Project/ArticleStandard/Article/detail/772540?ref=25 The European Federation of Pharmaceutical Industries and Associations has formally adopted a memorandum of understanding with key partners for a harmonized, European system for medicines verification. 2012-05-10T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192012/772540null HTML http://www.pharmtech.com/pharmtech/Industry-Briefs-May-7-2012/ArticleStandard/Article/detail/772594?ref=25 A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers. 2012-05-10T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192012/772594null HTML http://www.pharmtech.com/pharmtech/Want-your-marketing-messages-to-reach-the-right-au/ArticleStandard/Article/detail/771160?ref=25 2012-05-09T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771160null HTML http://www.pharmtech.com/pharmtech/News/Abbott-Reaches-Settlement-Agreement-on-Depakote/ArticleStandard/Article/detail/772711?ref=25 Abbott Laboratories will pay $1.6 billion to settle outstanding issues concerning past sales and marketing practices for its neurologic medication, Depakote. 2012-05-09T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192012/772711null HTML http://www.pharmtech.com/pharmtech/News/FDA-Issues-Final-Rule-on-Sterility-Testing-of-Biol/ArticleStandard/Article/detail/772509?ref=25 FDA issued a final rule on sterility testing on May 3, 2012, which amends the requirements for most licensed biological products and aims to provide manufacturers with the flexibility, as appropriate, to keep pace with technological and scientific advances. Many steps are changed or eliminated. 2012-05-08T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192012/772509null HTML http://www.pharmtech.com/pharmtech/Jim-Millers-Interphex-2012-Presentation/ArticleStandard/Article/detail/772499?ref=25 2012-05-08T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192012/772499null PDF http://www.pharmtech.com/pharmtech/News/Sanofi-Gains-Regulatory-Approval-for-Expansion-at-/ArticleStandard/Article/detail/772354?ref=25 Sanofi has received FDA and EMA approval for expansion of fill and finish operations for alglucosidase alfa. 2012-05-07T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192012/772354null HTML http://www.pharmtech.com/pharmtech/EquipNet---Asset-Accuracy-A-professional-appraisal/ArticleStandard/Article/detail/772387?ref=25 EquipNet - Asset Accuracy: A professional appraisal is essential to know what you have and what it?s worth 2012-05-07T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192012/772387null HTML http://www.pharmtech.com/pharmtech/Company+and+People+Notes/Week-of-Apr-30-2012-AstraZenecas-CEO-David-Brennan/ArticleStandard/Article/detail/771257?ref=25 AstraZeneca's CEO David Brennan To Retire; PRA, Amgen Reach New Biosimilar Agreement; and More. 2012-05-03T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771257null HTML http://www.pharmtech.com/pharmtech/News/Anticounterfeiting-Strategy-Launched-in-UK/ArticleStandard/Article/detail/771466?ref=25 The UK's Medicines and Healthcare products Regulatory Agency has launched a new anticounterfeiting strategy with the aim of curbing the occurrence of falsified medicines in the county's supply chain. 2012-05-03T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771466null HTML http://www.pharmtech.com/pharmtech/Feature+Articles/Optimizing-Drug-Delivery-for-Modern-Biologics/ArticleStandard/Article/detail/771898?ref=25 The author discusses potential opportunities to improve the patient experience through formulation and delivery device technologies. 2012-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771898/PT0512_102410543_82_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771898null XML http://www.pharmtech.com/pharmtech/In+the+Field/Regulation-and-Compliance/ArticleStandard/Article/detail/771901?ref=25 Q&A with David Elder of Strategic Compliance Consulting, PAREXEL International. Elder is a former senior official with FDA. 2012-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771901null XML http://www.pharmtech.com/pharmtech/IT/FDA-Explores-Options-to-Expand-Access-to-Non-Rx-Dr/ArticleStandard/Article/detail/771903?ref=25 Manufacturers seek clear path to develop safe-use approaches for more risky OTC therapies. 2012-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771903null XML http://www.pharmtech.com/pharmtech/Outsourcing/Some-Supply-Chain-Lessons-Can-Go-a-Long-Way-toward/ArticleStandard/Article/detail/771894?ref=25 Apple's experience with manufacturing facilities in China present opportunity for future best practice. 2012-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771894null XML http://www.pharmtech.com/pharmtech/Ingredients/Tackling-Global-Health-Concerns/ArticleStandard/Article/detail/771900?ref=25 Industry, the public sector, and individuals can play an important role in creating solutions. 2012-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771900null XML http://www.pharmtech.com/pharmtech/Regulatory+Corner/FDA-Perspectives-Scientific-Considerations-of-Forc/ArticleStandard/Article/detail/771905?ref=25 The author outlines the scientific aspects of forced degradation studies that should be considered in relation to ANDA submissions. 2012-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771905null XML http://www.pharmtech.com/pharmtech/In+the+Spotlight/In-the-Spotlight/ArticleStandard/Article/detail/771892?ref=25 New product reviews for May 2012. 2012-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771892null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Meeting-Manufacturing-Challenges-Tied-to-Extended-/ArticleStandard/Article/detail/771896?ref=25 Industry experts working with extended-release injectables discuss challenges and solutions to formulating and manufacturing these complex products. 2012-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771896/PT0512_CV1_Cover_120x90_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771896null XML http://www.pharmtech.com/pharmtech/Outsourcing+Outlook/Channeling-Steve-Jobs/ArticleStandard/Article/detail/771897?ref=25 Service providers must focus on delivering a superior customer experience. 2012-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771897null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Optimizing-Tableting-Processes-with-Quality-by-Des/ArticleStandard/Article/detail/771890?ref=25 A technical forum featuring Tim Freeman of Freeman Technology and Carl Levoguer of Malvern Instruments. 2012-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771890/PT0512_200464087-001_48_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771890null XML http://www.pharmtech.com/pharmtech/Online+Only/White-House-Releases-National-Bioeconomy-Blueprint/ArticleStandard/Article/detail/771205?ref=25 The Obama administration details five strategic imperatives to drive bioscience research as a means of economic growth. 2012-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771205null HTML http://www.pharmtech.com/pharmtech/News/GSK-Collaborates-on-New-Class-of-Medicines/ArticleStandard/Article/detail/771632?ref=25 GlaxoSmithKline has partnered with the US?s Yale University to design a potential new class of medicines that could be beneficial in areas such as oncology, inflammation and infection. 2012-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771632null HTML http://www.pharmtech.com/pharmtech/Standards+%26+Regulation/All-Eyes-Alert/ArticleStandard/Article/detail/771904?ref=25 It's better to catch costly mistakes in the laboratory before they reach the accounting department. 2012-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771904null XML http://www.pharmtech.com/pharmtech/Standards+%26+Regulation/The-Growing-Orphan-Drug-Paradigm/ArticleStandard/Article/detail/771899?ref=25 How niche strategies can offer mainstream potential for biopharmaceutical companies. 2012-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771899null XML http://www.pharmtech.com/pharmtech/News/Institute-of-Medicine-Releases-Report-on-Studying-/ArticleStandard/Article/detail/771652?ref=25 At the request of FDA, the IOM prepared a report containing recommendations for how FDA might better monitor the safety of drugs after they have been approved. 2012-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/biopharm/182012/771652null HTML http://www.pharmtech.com/pharmtech/CSR/The-Marriage-of-Global-Health-and-Sustainability/ArticleStandard/Article/detail/771212?ref=25 Industry leaders share their perspectives on how the pharmaceutical industry is and can further advance sustainability. 2012-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771212null HTML http://www.pharmtech.com/pharmtech/Outsourcing/Ways-to-Recover-Lost-Margins/ArticleStandard/Article/detail/771208?ref=25 Recovery audits and other past practices in procurement can improve the bottom line. 2012-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771208null XML http://www.pharmtech.com/pharmtech/News/Institute-of-Medicine-Releases-Report-on-Studying-/ArticleStandard/Article/detail/771650?ref=25 At the request of FDA, the IOM prepared a report containing recommendations for how FDA might better monitor the safety of drugs after they have been approved. 2012-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771650null HTML http://www.pharmtech.com/pharmtech/Outsourcing/Report-from-Poland/ArticleStandard/Article/detail/771893?ref=25 Poland's government aims to make the Eastern European country a biotech powerhouse. 2012-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771893/PT0512_87313525_18_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771893null XML http://www.pharmtech.com/pharmtech/Ingredients+Insider/Seeking-Chemocatalytic-and-Biocatalytic-Solutions/ArticleStandard/Article/detail/771902?ref=25 Advances in palladium-catalyzed hydrogenation, visible-light photocatalysis, and chemocatalyisis for heterocycles are some recent developments. 2012-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771902/PT0512_142022463_56_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771902null XML http://www.pharmtech.com/pharmtech/Ingredients+Insider/Formulation-Development-Forum-Targeted-Polymeric-N/ArticleStandard/Article/detail/771895?ref=25 Targeted polymeric nanoparticles are an important vehicle for controlling and targeting dosing of chemotherapeutic agents. 2012-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771895null XML http://www.pharmtech.com/pharmtech/Pump-Solutions-Group---Interest-Grows-in-Single-Us/ArticleStandard/Article/detail/771641?ref=25 Pump Solutions Group - Interest Grows in Single-Use Pumps 2012-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771641null HTML http://www.pharmtech.com/pharmtech/Online+Only/CROs-Urge-for-Modernization-of-Clinical-Trials/ArticleStandard/Article/detail/771206?ref=25 Clinical research organizations see reform in clinical-trial process, including the establishment of chief innovation officer at FDA. 2012-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771206null HTML http://www.pharmtech.com/pharmtech/CSR/GlaxoSmithKline-Outlines-Its-Sustainability-Goals/ArticleStandard/Article/detail/771209?ref=25 The company provides progress made in 2011 and future environmental objectives. 2012-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771209null HTML http://www.pharmtech.com/pharmtech/CSR/CSR-and-Sustainability-in-the-News/ArticleStandard/Article/detail/771210?ref=25 A roundup of developments in corporate social responsibility and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations 2012-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771210null HTML http://www.pharmtech.com/pharmtech/Troubleshooting/Facilitating-Efficient-Equipment-Cleaning/ArticleStandard/Article/detail/771891?ref=25 Equipment design and cleaning procedures both play a role in thorough sterilization and cleaning. 2012-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771891/PT0512_AlfaFigure-2B_63_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771891null XML http://www.pharmtech.com/pharmtech/Standards+%26+Regulation/Biological-Indicator-Growout-Times-The-Impact-on-E/ArticleStandard/Article/detail/771887?ref=25 The authors provide a review of test methodology and standards, including current industry and regulatory proposals, for biological indicator growout times. 2012-05-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771887null XML http://www.pharmtech.com/pharmtech/Manufacturing/Pan-Coating-and-Scale-Up-a-Practical-Guide-Based-o/ArticleStandard/Article/detail/771024?ref=25 There are various theories about how to scale up a solid dosage coating operation in a pan coater. This article provides a basic process understanding and scale-up theory based on first principles. 2012-05-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172012/771024null XML http://www.pharmtech.com/pharmtech/Analytics/Rapid-Microbial-Testing/ArticleStandard/Article/detail/771886?ref=25 In this technical forum, experts describe different methods of rapid microbial testing and their applications. 2012-05-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771886/PTsupp_56961327_s14_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771886null XML http://www.pharmtech.com/pharmtech/Regulation+Whitepapers/The-Regulatory-Paradox-of-Laboratory-Developed-Tes/ArticleStandard/Article/detail/681426?ref=25 The development of increasingly more complex and sophisticated in vitro diagnostic (IVD) devices by clinical laboratories has precipitated FDA concern regarding a lack of product controls. These tests are often produced using available marketed kits, may include components purchased from a commercial supplier, and are offered for use as a diagnostic service. FDA contends that test ingredients or components used in the production of LDTs are essentially unregulated, therefore, of unpredictable quality. The regulatory boundary between FDA-regulated medical devices LDTs exempt from FDA jurisdiction remains somewhat blurred; however, the looming finalization of the CPG and IDVMIA guidance documents stand to better clarify this borderline. 2012-05-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/322010/681426null REMOTE http://www.pharmtech.com/pharmtech/Manufacturing/Preventing-Contamination-with-Preservatives/ArticleStandard/Article/detail/771019?ref=25 If a product does not have its own antimicrobial properties, then a preservative must be used to ensure microbiological safety. 2012-05-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172012/771019null XML http://www.pharmtech.com/pharmtech/Standards+%26+Regulation/Parametric-Release-and-Real-Time-Release-Testing/ArticleStandard/Article/detail/771883?ref=25 Parametric release and real-time testing use manufacturing data to ensure that products are made according to defined standards. PharmTech talks to Boehringer Ingelheim's Heribert Hausler about these issues. 2012-05-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771883null XML http://www.pharmtech.com/pharmtech/News/ArticleStandard/Article/detail/771020?ref=25 EMA Toughens up on Transparency 2012-05-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172012/771020null XML http://www.pharmtech.com/pharmtech/Whitepapers/Biosimilars-Global-Impact-of-the-Biologics-Price-C/ArticleStandard/Article/detail/738098?ref=25 On March 23, 2010, President Obama signed into law the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which amends the Public Health Services Act (PHS Act) to create an abbreviated approval pathway for biological products that are shown to be highly similar (i.e., biosimilar) to or interchangeable with an FDA-licensed reference biological product. Biological products are generally derived from living material (e.g., human, animal, or microorganism), have complex structures and are usually not fully characterized. 2012-05-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/362011/738098null REMOTE http://www.pharmtech.com/pharmtech/Manufacturing/Using-Closed-Vial-Technology-in-Aseptic-Filling/ArticleStandard/Article/detail/771884?ref=25 Closed-vial technology is an alternative to traditional glass vial filling that reduces the risk of contamination for the patient, simplifies the filling process, and provides easier handling for healthcare providers. 2012-05-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771884/PTsupp_vial-filling-P24-(small)_s36_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771884null XML http://www.pharmtech.com/pharmtech/Manufacturing/Atomic-Force-Microscopy/ArticleStandard/Article/detail/771027?ref=25 An analytical technique that is receiving increased attention in the pharmaceutical industry is atomic force microscopy. We interview Mark Leaper from the UK's De Montfort University to find out more about this technology. 2012-05-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172012/771027null XML http://www.pharmtech.com/pharmtech/Standards+%26+Regulation/Application-of-Sterilization-by-Gamma-Radiation-fo/ArticleStandard/Article/detail/771889?ref=25 This paper examines the process of gamma irradiation of plastic materials used as part of single-use disposable systems in the pharmaceutical and biotechnology sectors, with a focus on validation requirements. 2012-05-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771889/PTsupp_Sandle_Figure1_s28_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771889null XML http://www.pharmtech.com/pharmtech/Supply-Chain-Lessons/ArticleStandard/Article/detail/771022?ref=25 Once again, Apple is doing something the rest of the world should be paying attention to, only this time it's about the company's approach to managing the global supply chain—even when things go wrong. 2012-05-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172012/771022null XML http://www.pharmtech.com/pharmtech/Channeling-Steve-Jobs/ArticleStandard/Article/detail/771026?ref=25 Service providers must focus on delivering a superior customer experience. 2012-05-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172012/771026null XML http://www.pharmtech.com/pharmtech/Seeking-New-Chemocatalytic-and-Biocatalytic-Soluti/ArticleStandard/Article/detail/771021?ref=25 Advances in palladium-catalysed hydrogenation, visible-light photocatalysis and improved chemocatalytic approaches for making heterocyclic compounds are some recent industry developments. 2012-05-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172012/771021null XML http://www.pharmtech.com/pharmtech/Manufacturing/Taxing-Times-for-French-Pharma/ArticleStandard/Article/detail/771025?ref=25 As the French Presidential campaign is underway, and politicians collaborate with businesses to revive a flagging economy, the pharmaceutical industry seizes the chance to lobby for equitable taxation to give the sector a much-needed boost. 2012-05-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172012/771025null XML http://www.pharmtech.com/pharmtech/News/FDA-Issues-Warning-Letters-to-Ten-Companies-for-La/ArticleStandard/Article/detail/771352?ref=25 FDA has issued Warning Letters to 10 companies that manufacture and distribute dietary supplements that contain dimethylamylamine. FDA cited the companies for marketing the supplements without submitting evidence that the products are safe. 2012-05-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771352null HTML http://www.pharmtech.com/pharmtech/Whitepapers/Risk-Evaluation-and-Mitigation-Strategies-REMS-Und/ArticleStandard/Article/detail/738099?ref=25 The highly publicized withdrawal of a number of unsafe drugs from the market over the last several years has led to strong criticism of FDA's ability to protect the public health, resulting in a call for fundamental changes in the United States drug safety system. A report commissioned by FDA in the wake of the Vioxx® withdrawal, and subsequently issued by the Institute of Medicine in 2006, concluded that the science of drug safety needed major improvements. 2012-05-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/362011/738099null REMOTE http://www.pharmtech.com/pharmtech/Outsourcing/Bioprocessing-Trends-Annual-Survey-Results/ArticleStandard/Article/detail/771885?ref=25 Readers share their views on bioprocessing challenges, equipment use, and outsourcing trends in our annual bioprocessing equipment and processing survey. 2012-05-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771885/PTsupp0512_Cv1_120x90_thumbnail.jpg XML http://www.pharmtech.com/pharmtech/All-Eyes-Alert/ArticleStandard/Article/detail/771023?ref=25 It's better to catch costly mistakes in the laboratory before they reach the accounting department. 2012-05-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172012/771023null XML http://www.pharmtech.com/pharmtech/Regulation+Whitepapers/Evaluating-the-Electronic-Submissions-Challenge-in/ArticleStandard/Article/detail/681430?ref=25 eCTD, XML, SPL, electronic signatures, 21 CFR Part 11, electronic gateway…these are the buzz words of the 21st century for pharmaceutical and biotechnology drug development. Today, these terms represent a challenge to each and every company in the pharmaceutical industry…from R&D to contract manufacturing to CROs and to regulatory agencies worldwide. Why? An organization must decide WHEN, not IF, they will integrate these new technologies and guidelines into their internal business processes, and if so, HOW? 2012-05-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/322010/681430null REMOTE http://www.pharmtech.com/pharmtech/Manufacturing/A-More-Rational-Approach-for-Sterile-Product-Manuf/ArticleStandard/Article/detail/771888?ref=25 The authors assert that the current gulf between aseptic processing and terminal sterilization can be bridged by re-examining fundamental regulatory philosophies for sterile-product manufacturing. 2012-05-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771888/PTsupp_119672160_s48_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771888null XML http://www.pharmtech.com/pharmtech/Online+Only/Watson-Pharmaceuticals-to-Acquire-Actavis-for-56-B/ArticleStandard/Article/detail/771231?ref=25 In a move designed to increase its international presence, Watson Pharmaceuticals has agreed to acquire Actavis for EUR 4.25 billion ($5.6 billion). 2012-04-30T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771231null HTML http://www.pharmtech.com/pharmtech/The-iNexerai-MP-UHPLC-for-LCMS-analysis-in-drug-de/ArticleStandard/Article/detail/770048?ref=25 Shimadzu has introduced the Nexera MP UHPLC as a Front End system for LC/MS. The Nexera MP is perfect for LC/MS analysis conducted in pharmacokinetics and synthesis stages in drug detection processes. 2012-04-27T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/162012/770048null HTML http://www.pharmtech.com/pharmtech/Industry-Briefs-Apr-30-2012/ArticleStandard/Article/detail/771253?ref=25 A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers. 2012-04-26T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182012/771253null HTML http://www.pharmtech.com/pharmtech/Company+and+People+Notes/Week-of-Apr-23-2012-AstraZeneca-to-Acquire-Ardea-B/ArticleStandard/Article/detail/770552?ref=25 AstraZeneca to Acquire Ardea Biosciences; Pfizer to Divest Nutrition Business to Nestlé; and More. 2012-04-26T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172012/770552null HTML http://www.pharmtech.com/pharmtech/News/GSK-Divests-OTC-Brands-Worth-2647-Million/ArticleStandard/Article/detail/770405?ref=25 GlaxoSmithKline has reached an agreement to divest certain over-the-counter brands in selected territories to South Africa's Aspen Pharmacare Holdings for approximately $264.7 million. 2012-04-26T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172012/770405null HTML http://www.pharmtech.com/pharmtech/Industry-Briefs-Apr-23-2012/ArticleStandard/Article/detail/770551?ref=25 A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers. 2012-04-26T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172012/770551null HTML http://www.pharmtech.com/pharmtech/Whitepapers/Improving-Product-Quality-with-Risk-Assessment-Too/ArticleStandard/Article/detail/739321?ref=25 With the product lifecycle moving so fast, many organizations may ask the question, "how can we effectively measure quality?" The answer is Risk Management. Learn the elements of Risk Management and how they help to identify, prevent, and mitigate risk throughout an organization. 2012-04-25T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/382011/739321null REMOTE http://www.pharmtech.com/pharmtech/Whitepapers/Finding-the-right-contract-manufacturer/ArticleStandard/Article/detail/762514?ref=25 Contract manufacturing became popular in many industries during the 1990s as a way to counter rising costs and to reinvestment. The pharmaceutical industry has been slow to adopt this practice because of its absolute need for secrecy. However, with fewer blockbuster drugs in the pipeline, companies are on the lookout for an enduring solution to meet market challenges. These include rising process costs resulting from stricter quality control criteria, evolving technologies, which are becoming more complex and costly, and the increasing stringency of regulatory standards. To maintain or expand market shares, pharmaceutical companies must devise new strategies to remain competitive. 2012-04-25T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/092012/762514null REMOTE http://www.pharmtech.com/pharmtech/Whitepapers/Implementing-Disposable-Cleanroom-Apparel-into-the/ArticleStandard/Article/detail/766654?ref=25 This paper addresses the benefits of disposable cleanroom apparel versus reusable apparel. It explains how disposable cleanroom apparel can help play a role in helping pharmaceutical manufacturers reduce their waste stream while reducing the risk of contamination. 2012-04-25T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/132012/766654null REMOTE http://www.pharmtech.com/pharmtech/Whitepapers/OPC-Data-sharing-between-Pharmaceuticals-and-CMOs/ArticleStandard/Article/detail/767223?ref=25 Competition in the Pharmaceutical industry is driving companies to find efficient production strategies. Outsourcing production to CMOs is popular and with it the need to share production data. 2012-04-25T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/142012/767223null REMOTE http://www.pharmtech.com/pharmtech/Whitepapers/50--FDA-Acronyms-that-Matter-to-Your-Business/ArticleStandard/Article/detail/767492?ref=25 This e-book is a convenient and comprehensive reference of definitions, insights, and additional resources that provide a fundamental understanding FDA regulations and to achieve Good Manufacturing Practices and FDA compliance. 2012-04-25T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/142012/767492null REMOTE http://www.pharmtech.com/pharmtech/Whitepapers/AQUEOUS-CRITICAL-CLEANING-IN-PHARMACEUTICAL-MANUFA/ArticleStandard/Article/detail/762504?ref=25 Examination of the benefits of aqueous cleaning for pharmaceutical manufacturing. Any equipment from tablet press to stainless steel mixing tanks can achieve their defined critically clean criteria using aqueous cleaning. Alconox is the leader in pharmaceutical critical cleaning detergents. 2012-04-25T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/092012/762504null REMOTE http://www.pharmtech.com/pharmtech/Whitepapers/Technical-Choices-for-WFI-Production/ArticleStandard/Article/detail/766646?ref=25 WFI from a ‘still or from two pass RO? Is the ‘still unquestionably safer than the two pass RO? The question continues to cause discussion between the jurisdictions. Neither is foolproof. 2012-04-25T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/132012/766646null REMOTE http://www.pharmtech.com/pharmtech/Analytics+Whitepaper/Sample-Preparation-for-Quantitative-Metal-Impurity/ArticleStandard/Article/detail/770909?ref=25 When analyzing for trace metals using inductively coupled plasma (ICP), sample preparation is crucial. The key question is what is the best method to get the test article in solution? 2012-04-25T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172012/770909null REMOTE http://www.pharmtech.com/pharmtech/Whitepapers/How-customized-European-Qualified-Person-QP-traini/ArticleStandard/Article/detail/732632?ref=25 As companies begin allocating their 2012 training budgets, it?s time to see what alternative pharmaceutical training is on offer in the US and NSF-DBA?s QLP modular course, customized from Europe may be just the answer. 2012-04-25T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/312011/732632null REMOTE http://www.pharmtech.com/pharmtech/News/EC-Offers-Cash-Prize-for-Vaccine-Stability/ArticleStandard/Article/detail/770627?ref=25 The European Commission is offering a EUR 2-million ($2.64 million) inducement prize to encourage innovation in the area of cold-chain logistics and vaccine stability. 2012-04-25T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172012/770627null HTML http://www.pharmtech.com/pharmtech/Whitepapers/Determination-of-Low-Concentration-Methanol-in-Alc/ArticleStandard/Article/detail/724256?ref=25 We present Raman spectroscopy as a quick and lower cost alternative to verifying the existence of low concentration methanol in alcohol. 2012-04-25T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/222011/724256null REMOTE http://www.pharmtech.com/pharmtech/Outsourcing+Whitepaper/WORKING-WITH-A-CDMO-TO-IDENTIFY-OPTIMAL-PACKAGING-/ArticleStandard/Article/detail/770902?ref=25 There are many factors to take into consideration when selecting or designing a packaging component. Working with a contract development and manufacturing organization early in the process helps eliminate packaging problems that may arise after the development stage. 2012-04-25T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172012/770902null REMOTE http://www.pharmtech.com/pharmtech/Whitepapers/Quality-Management-Systems-Demystified/ArticleStandard/Article/detail/757064?ref=25 Learn how companies are utilizing best-of-breed ERP, EQMS, and PLM systems to save organizations money while increasing compliance at the same time. 2012-04-25T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/042012/757064null REMOTE http://www.pharmtech.com/pharmtech/Drug+delivery+Whitepaper/An-Introduction-to-Waters-T-Wave-Devices-Unique-Te/ArticleStandard/Article/detail/770911?ref=25 This white paper provides an Introduction to Waters® T-Wave™ (Travelling Wave) Devices, a unique technology engineered by Waters to enable advanced mass spectrometry performance. T-Wave Technology has been used in a number of creative and innovative ways to enhance the performance and functionality of Waters mass spectrometers, sometimes adding unique capabilities not possible by other means. 2012-04-25T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172012/770911null REMOTE http://www.pharmtech.com/pharmtech/Analytics+Whitepaper/UV-Vis-Performance-Validation-Software-for-Improve/ArticleStandard/Article/detail/770904?ref=25 Conducting instrument validation manually is a cumbersome task. This paper presents software that makes it easy to conduct an entire series of regulation and standards-related operations, from the setting of validation conditions to data measurement, pass/fail judgment, and file storage. 2012-04-25T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172012/770904null REMOTE http://www.pharmtech.com/pharmtech/Outsourcing+Whitepaper/Choosing-the-Best-Microbial-ID-Contract-Lab/ArticleStandard/Article/detail/770912?ref=25 To justify a decision to outsource, an accurate analysis by the organization’s technical, quality and financial team is required. Presented in this publication are six critical elements to evaluate a contract laboratory service for microbial identifications. Outsourcing can drive cost savings, increase operational efficiency and leverage internal resources to focus on core competencies. 2012-04-25T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172012/770912null REMOTE http://www.pharmtech.com/pharmtech/News/Merck-KGaA-Announces-Job-Cuts/ArticleStandard/Article/detail/770628?ref=25 Merck KGaA has revealed further details about its previously announced restructuring program, including plans to eliminate approximately 580 jobs. 2012-04-25T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172012/770628null HTML http://www.pharmtech.com/pharmtech/Packaging+%26+Labeling+Whitepaper/Benefits-of-a-Contract-Packaging-Partner/ArticleStandard/Article/detail/770910?ref=25 As pharmaceutical companies face multiple pressures – to fast track innovative drugs and delivery systems, to meet increasingly stringent regulations and to grow resources despite increasing costs – outsourcing of packaging is reducing those pressures. Three essential characteristics are often overlooked, but essential, when choosing a packaging partner. 2012-04-25T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172012/770910null REMOTE http://www.pharmtech.com/pharmtech/Whitepapers/Hot-Melt-Extrusion-HME---nano-scale-compounding-de/ArticleStandard/Article/detail/724253?ref=25 Hot melt extrusion is emerging as a preferred manufacturing methodology for dosage forms. The high cost and limited availability of raw materials during the development phase has resulted in the need to process small amounts of API's/excipients via extrusion to determine process viability. Experimental data is presented on a new twin screw extrusion device that can process as little as 20 to 100 gram micro-batches, as well as a scale-up path. 2012-04-25T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/222011/724253null REMOTE http://www.pharmtech.com/pharmtech/Whitepapers/A-Scientific-Approach-to-Good-Manufacturing-Practi/ArticleStandard/Article/detail/762243?ref=25 Contract manufacturing organizations (CMOs) exist in an environment of continuous improvement and evolving quality standards. By scientifically affirming every decision and by embracing integral approaches to quality, CMOs can reduce regulatory risk and become a leader in developing best practices meeting current Good Manufacturing Practices (cGMPs). 2012-04-25T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/092012/762243null REMOTE http://www.pharmtech.com/pharmtech/Whitepapers/Forensics-Can-Help-Identify-Particulate-Contaminat/ArticleStandard/Article/detail/762249?ref=25 New forensic techniques and approaches are essential for resolving potential safety issues. This white paper discusses an investigative approach to help companies avoid FDA Form 483s by addressing OOS results and nonconformance issues. 2012-04-25T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/092012/762249null REMOTE http://www.pharmtech.com/pharmtech/News/FDA-Reports-Improvement-in-Postmarket-Drug-Oversig/ArticleStandard/Article/detail/770470?ref=25 FDA highlights success of CDER's drug-monitoring program. 2012-04-24T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172012/770470null HTML