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. 2012-02-22T23:00:43Z http://www.pharmtech.com/pharmtech/Industry-Briefs-Feb-20-2012/ArticleStandard/Article/detail/761214?ref=25 A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers. 2012-02-23T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/082012/761214null HTML http://www.pharmtech.com/pharmtech/Surety-LLC---Does-Your-ELN-or-Lab-System-Have-the-/ArticleStandard/Article/detail/761219?ref=25 Surety LLC - Does Your ELN or Lab System Have the Right IP Protection Controls in Place? 2012-02-21T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/082012/761219null HTML http://www.pharmtech.com/pharmtech/DPT---Effective-Controlled-Substances--Supply-Chai/ArticleStandard/Article/detail/761315?ref=25 DPT - Effective Controlled Substances- Supply Chain Management 2012-02-21T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/082012/761315null HTML http://www.pharmtech.com/pharmtech/ANTON---Characterizing-lamellar-systems-with-SAXS/ArticleStandard/Article/detail/761372?ref=25 ANTON - Characterizing lamellar systems with SAXS 2012-02-21T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/082012/761372null HTML http://www.pharmtech.com/pharmtech/Vaisala---A-GMP-Warehouse-Mapping-Guide/ArticleStandard/Article/detail/761081?ref=25 Vaisala - A GMP Warehouse Mapping Guide 2012-02-21T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/082012/761081null HTML http://www.pharmtech.com/pharmtech/Hospira/ArticleStandard/Article/detail/758689?ref=25 Hospira One 2 One®: contract development and fill-finish manufacturing of injectable products packaged in vials, PFS, cartridges, ampoules. 2012-02-17T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/072012/758689null HTML http://www.pharmtech.com/pharmtech/Parenteral-Packaging/ArticleStandard/Article/detail/758413?ref=25 PDA organizes this conference to address the technical and regulatory issues related to parenteral packaging. Chemical, physical and microbiological aspects will be considered and current regulatory challenges will be discussed. Two Training Courses on Container Closure Development or Selection and Utilization of Glass Containers in Pharmaceutical Packaging will be given. 2012-02-17T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/062012/758413null HTML http://www.pharmtech.com/pharmtech/News/South-Africa-Plans-Joint-Venture-for-New-API-Plant/ArticleStandard/Article/detail/758780?ref=25 The South African government is involved in talks with the Swiss biopharmaceutical company Lonza regarding a joint venture to construct the country's first plant to manufacture APIs for antiretroviral medicines. 2012-02-16T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/072012/758780null HTML http://www.pharmtech.com/pharmtech/News/FDA-Releases-Draft-Guidance-on-Monitoring-Crude-He/ArticleStandard/Article/detail/758788?ref=25 FDA has released a draft guidance for API manufacturers in response to a 2008 incident in which heparin sourced from China was adulterated with oversulfated chondroitin sulfate, causing serious adverse reactions in patients. 2012-02-16T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/072012/758788null HTML http://www.pharmtech.com/pharmtech/Industry-Briefs-Feb-13-2012/ArticleStandard/Article/detail/758767?ref=25 A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers. 2012-02-16T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/072012/758767null HTML http://www.pharmtech.com/pharmtech/Vaisala---8-Steps-to-ValidatingMapping-a-Chamber/ArticleStandard/Article/detail/759096?ref=25 Vaisala - 8 Steps to Validating/Mapping a Chamber 2012-02-16T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/072012/759096null HTML http://www.pharmtech.com/pharmtech/News/White-Houses-2013-Budget-Includes-FDA-Increases/ArticleStandard/Article/detail/758789?ref=25 President Barack Obama released his budget proposal for fiscal year 2013. Included in the proposed budget is a $654-million increase in FDA funding, for a total FDA budget request of $4.49 billion. 2012-02-16T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/072012/758789null HTML http://www.pharmtech.com/pharmtech/Kemwell-Biopharma-CC-2011/ArticleStandard/Article/detail/759021?ref=25 Kemwell Biopharma CC 2011 2012-02-16T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/072012/759021null PDF http://www.pharmtech.com/pharmtech/Online+Only/Regulatory-Roundup-EMA-Releases-Genetic-Variabilit/ArticleStandard/Article/detail/758732?ref=25 EMA Releases Genetic Variability Guideline. 2012-02-16T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/072012/758732null HTML http://www.pharmtech.com/pharmtech/Online+Only/Determining-Whether-Dry-Dispersion-Can-Be-Used-in-/ArticleStandard/Article/detail/758294?ref=25 We need to measure the particle size of a moisture-sensitive powder. We would like to use dry analysis on our laser-diffraction system, but the particles are fragile and we're struggling to get robust results. Is wet measurement with a nonaqueous solvent the only option? 2012-02-15T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/062012/758294null HTML http://www.pharmtech.com/pharmtech/Formulation/Comparing-Lyophilization-in-Vials-and-Dual-Chamber/ArticleStandard/Article/detail/758287?ref=25 The author discusses the relative advantages and disadvantages of lyophilization in vials and dual-chamber systems. 2012-02-15T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/062012/758287null HTML http://www.pharmtech.com/pharmtech/Online+Only/Mid-Size-Extruders-Enable-Scale-Up-of-Hot-Melt-Ext/ArticleStandard/Article/detail/758278?ref=25 With the increasing use of hot-melt extrusion, extruder manufacturers have developed mid-size twin-screw extruders that facilitate process development and scale-up to commercial processes. 2012-02-15T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/062012/758278null HTML http://www.pharmtech.com/pharmtech/News/EMA-Guidance-on-Genetic-Variability/ArticleStandard/Article/detail/758876?ref=25 The EMA has published a guideline that addresses the influence of patients? genetic variability on drug pharmacokinetics. 2012-02-15T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/072012/758876null HTML http://www.pharmtech.com/pharmtech/Editor%27s+Picks/February-2012-Editors-Picks-Products-from-ACS-Valv/ArticleStandard/Article/detail/758315?ref=25 PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the February 2012 edition from ACS Valves and G-Con. 2012-02-15T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/062012/758315null HTML http://www.pharmtech.com/pharmtech/AMRI-CC-2011/ArticleStandard/Article/detail/758915?ref=25 AMRI CC 2011 2012-02-15T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/072012/758915null PDF http://www.pharmtech.com/pharmtech/AMRI---A-Scientific-Approach-to-Good-Manufacturing/ArticleStandard/Article/detail/758711?ref=25 AMRI - A Scientific Approach to Good Manufacturing Practices 2012-02-14T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/072012/758711null HTML http://www.pharmtech.com/pharmtech/Vetter---Finding-the-right-contract-manufacturer/ArticleStandard/Article/detail/758764?ref=25 Vetter - Finding the right contract manufacturer 2012-02-14T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/072012/758764null HTML http://www.pharmtech.com/pharmtech/The-iNexerai-MP-UHPLC-for-LCMS-analysis-in-drug-de/ArticleStandard/Article/detail/758245?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. 2012-02-10T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/062012/758245null HTML http://www.pharmtech.com/pharmtech/News/GlaxoSmithKline-Tracks-RampD-Performance/ArticleStandard/Article/detail/758046?ref=25 GlaxoSmithKline released its fourth quarter and full year 2011 earnings report, which showed its return on R&D to be 12%—up from 11% in 2010, and closing in on the company's goal of a 14% return. 2012-02-09T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/062012/758046null HTML http://www.pharmtech.com/pharmtech/News/EMA-to-Implement-Pharmacovigilance/ArticleStandard/Article/detail/758068?ref=25 The European Medicines Agency (EMA) has published an implementation plan for Europe's new pharmacovigilance legislation, which comes into force in July with the aim of improving the safety and risk–benefit monitoring of drugs. The new legislation will represent the biggest change in the legal framework of the industry since EMA was first established in 1995. 2012-02-09T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/062012/758068null HTML http://www.pharmtech.com/pharmtech/Industry-Briefs-Feb-6-2012/ArticleStandard/Article/detail/758038?ref=25 A roundup of other company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers. 2012-02-09T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/062012/758038null HTML http://www.pharmtech.com/pharmtech/Online+Only/Regulatory-Roundup-FDA-Addresses-the-Regulation-an/ArticleStandard/Article/detail/758002?ref=25 FDA Addresses the Regulation and Approval Process of PET Drugs. 2012-02-09T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/062012/758002null HTML http://www.pharmtech.com/pharmtech/News/Pfizer-Contraceptive-Pill-Packaging-Error-Leads-to/ArticleStandard/Article/detail/758050?ref=25 Following a packaging error affecting birth-control pills, Pfizer has issued a one-million pack recall and warned women in the US who have been taking the medication during the last several months to consult with their physicians. 2012-02-09T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/062012/758050null HTML http://www.pharmtech.com/pharmtech/Company+and+People+Notes/Week-of-Feb-6-2012-AstraZeneca-Restructures-Catale/ArticleStandard/Article/detail/758037?ref=25 AstraZeneca Restructures; Catalent Completes Expansion in Italy; and More. 2012-02-09T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/062012/758037null HTML http://www.pharmtech.com/pharmtech/New-look-digital-magazine/ArticleStandard/Article/detail/758155?ref=25 Pharmaceutical Technology Europe has launched a new look digital magazine. 2012-02-08T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/062012/758155null HTML http://www.pharmtech.com/pharmtech/News/FDA-Commissioner-Testifies-for-PDUFA-Reauthorizati/ArticleStandard/Article/detail/758062?ref=25 Last week, FDA Commissioner Margaret A. Hamburg testified before the House Committee on Energy and Commerce, Subcommittee on Health to support the fifth authorization of the Prescription Drug User Fee Act, also known as PDUFA V. She also outlined a series of recommendations, sent to Congress in January 2012, to include in PDUFA V. 2012-02-08T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/062012/758062null HTML http://www.pharmtech.com/pharmtech/Nice-Insights-Business-Data-Quarter-4-2011/ArticleStandard/Article/detail/758058?ref=25 2012-02-07T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/062012/758058null PDF http://www.pharmtech.com/pharmtech/News/EC-Closes-Servier-Investigation/ArticleStandard/Article/detail/757480?ref=25 The European Commission (EC) has closed an investigation into Servier that accused the company of providing "misleading" and "incorrect" information to the EC?s pharmaceutical sector inquiry. 2012-02-03T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757480null HTML http://www.pharmtech.com/pharmtech/The-iNexerai-MP-UHPLC-for-LCMS-analysis-in-drug-de/ArticleStandard/Article/detail/756555?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. 2012-02-03T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/032012/756555null HTML http://www.pharmtech.com/pharmtech/Regulatory+Corner/Inside-ICH-ICH-Implementation-Support/ArticleStandard/Article/detail/757448?ref=25 ICH Q8, Q9, and Q10 support and implications for the future. 2012-02-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757448null XML http://www.pharmtech.com/pharmtech/Outsourcing/Sustainable-Investment/ArticleStandard/Article/detail/757450?ref=25 Pharma announces plans for the year ahead at annual JPMorgan Global Healthcare conference. 2012-02-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757450null XML http://www.pharmtech.com/pharmtech/Standards+%26+Regulation/An-Enhanced-Approach-to-Drug-Substance-Development/ArticleStandard/Article/detail/757451?ref=25 FDA and industry expert working group representatives discuss the pending ICH Q11 guideline. 2012-02-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757451/PT0212_001_Cover_120-x-90_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757451null XML http://www.pharmtech.com/pharmtech/Outsourcing/Report-from-India/ArticleStandard/Article/detail/757454?ref=25 The Asian nation is strategizing to take the lead over its regional competitors in pharmaceutical exports. 2012-02-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757454/PT0212_16_101884043_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757454null XML http://www.pharmtech.com/pharmtech/Outsourcing+Outlook/Biomanufacturing-Outlook/ArticleStandard/Article/detail/757475?ref=25 Industry optimism is on the rise for 2012. 2012-02-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757475null XML http://www.pharmtech.com/pharmtech/Standards+%26+Regulation/In-the-Spotlight/ArticleStandard/Article/detail/757444?ref=25 New product reviews for February 2012. 2012-02-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757444null XML http://www.pharmtech.com/pharmtech/Online+Only/FDA-Files-Consent-Decree-Against-Ranbaxy/ArticleStandard/Article/detail/757407?ref=25 The US Department of Justice, on behalf of FDA, filed a consent decree of permanent injunction against the generic-drug manufacturer Ranbaxy in the US District Court of Maryland. The decree was filed on Jan. 25, 2012, and is subject to court approval. 2012-02-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757407null HTML http://www.pharmtech.com/pharmtech/Standards+%26+Regulation/Shipping-with-the-Enemy/ArticleStandard/Article/detail/757442?ref=25 A nickel's worth of free advice to the competition could come at the expense of your bottom line. 2012-02-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757442null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Optimizing-Adjuvant-Filtration-A-Technical-Forum/ArticleStandard/Article/detail/757449?ref=25 Experts discuss solutions for filter bacterial retention and related challenges. Contains online bonus material. 2012-02-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757449/PT0212_38_Sartorius_0167_PG6_RGB_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757449/Bonus_main.gif http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757449null XML http://www.pharmtech.com/pharmtech/News/Pfizers-2011-Financial-Information-Shows-Overall-I/ArticleStandard/Article/detail/757399?ref=25 Pfizer announced a decrease in fourth-quarter revenues, but a slight increase in full-year 2011 revenues in its financial report on Jan. 31, 2012. 2012-02-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757399null HTML http://www.pharmtech.com/pharmtech/Viewpoint/Saving-the-Next-Generation-of-Regulatory-Scientist/ArticleStandard/Article/detail/757447?ref=25 New educational programs are key to the industry's future and to safe, available drugs. 2012-02-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757447null XML http://www.pharmtech.com/pharmtech/IT/FDAs-Social-Media-Insight/ArticleStandard/Article/detail/757446?ref=25 Guidance offered on how to deal with off-label information requests. 2012-02-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757446null XML http://www.pharmtech.com/pharmtech/Statistical+Solutions/Reducing-Common-Cause-Variation/ArticleStandard/Article/detail/757453?ref=25 Where is the variability coming from and what have we done to minimize it? 2012-02-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757453null XML http://www.pharmtech.com/pharmtech/Ingredients+Insider/Expanding-Capabilities-in-the-Pharmaceutical-Cold-/ArticleStandard/Article/detail/757455?ref=25 As biopharmaceutical development and commercialization increases, companies are expanding their cold-chain capabilities. 2012-02-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757455null XML http://www.pharmtech.com/pharmtech/News/Pharma-Targets-Tropical-Diseases/ArticleStandard/Article/detail/757415?ref=25 Pfizer, Sanofi, GlaxoSmithKline, and other major pharmaceutical companies have joined forces and pledged to defeat 10 neglected tropical diseases by 2020. The consortium comprises 13 pharmaceutical companies, the United States, United Kingdom, and United Arab Emirates governments, the Bill & Melinda Gates Foundation, the World Health Organization, and several other global health entities. 2012-02-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757415null HTML http://www.pharmtech.com/pharmtech/Industry-Briefs-Jan-30-2012/ArticleStandard/Article/detail/757422?ref=25 A roundup of other company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers. 2012-02-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757422null HTML http://www.pharmtech.com/pharmtech/BioForum/Single-Use-High-Capacity-Membrane-Chromatography/ArticleStandard/Article/detail/757441?ref=25 Debottlenecking downstream mAb purification. 2012-02-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757441null XML http://www.pharmtech.com/pharmtech/Peer-Reviewed+Research/Evaluating-Impurities-in-Drugs-Part-I-of-III/ArticleStandard/Article/detail/757445?ref=25 In Part I of a three-part article, the authors discuss what constitutes an impurity and the potential sources of impurities in APIs and finished drug products. 2012-02-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757445/PT0212_46_95012107_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757445null XML http://www.pharmtech.com/pharmtech/Company+and+People+Notes/Week-of-Jan-30-2012-Amgen-Agrees-to-Micromet-for-1/ArticleStandard/Article/detail/757394?ref=25 Amgen Agrees to Micromet for $1.16 Billion; Cephalon Issues Recall of Treanda; and More. 2012-02-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757394null HTML http://www.pharmtech.com/pharmtech/Regulatory+Corner/FDA-and-Justice-Department-Address-Drug-Quality-Co/ArticleStandard/Article/detail/757452?ref=25 More collaboration and expanded oversight aim to compel manufacturers to follow GMPs. 2012-02-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757452null XML http://www.pharmtech.com/pharmtech/Ingredients/Formulation-Development-Forum-Boronate-Cross-linke/ArticleStandard/Article/detail/757443?ref=25 A new class of nanoparticles hold promise for preventing premature drug release and offering greater accuracy and effectiveness in drug delivery. 2012-02-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757443null XML http://www.pharmtech.com/pharmtech/News/PhRMA-Transitions-Management-of-its-BenefitndashRi/ArticleStandard/Article/detail/757395?ref=25 PhRMA announced that it will transition the management of its benefit–risk action team to the Centre for Innovation in Regulatory Science (CIRS). CIRS is a neutral, independent UK-based subsidiary company, forming part of the Intellectual Property and Science business of Thomson Reuters. 2012-02-02T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757395null HTML http://www.pharmtech.com/pharmtech/Christine-Moore-Bio/ArticleStandard/Article/detail/757617?ref=25 <-- --> 2012-02-01T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757617null HTML http://www.pharmtech.com/pharmtech/Outsourcing/Strategies-for-Preferred-Provider-Partnerships/ArticleStandard/Article/detail/757459?ref=25 The author examines recent examples of preferred-provider collaborations. 2012-02-01T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757459/PTsupp0212_S6_82020838_thumbnail.jpg XML http://www.pharmtech.com/pharmtech/Whitepapers/Donning-by-Design/ArticleStandard/Article/detail/757375?ref=25 This paper addresses the importance of process protection in cleanrooms via the appropriate cleanroom suit. It provides an overview of the sterile cleanroom apparel category and defines key areas for improvement. It introduces a new concept for sterile cleanroom gowning to help minimize the problems associated with current technologies. 2012-02-01T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757375null REMOTE http://www.pharmtech.com/pharmtech/Manufacturing/Understanding-Gamma-Sterilisation/ArticleStandard/Article/detail/757198?ref=25 This column will address some of the questions on how single use systems are sterilized by gamma irradiation and what documentation may be requested by regulators. 2012-02-01T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/042012/757198/Jmartin_main.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/042012/757198null XML http://www.pharmtech.com/pharmtech/News-FDAs-Social-Media-Insight/ArticleStandard/Article/detail/757199?ref=25 How can pharma make use of social media opportunities without running afoul of regulators? 2012-02-01T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/042012/757199null XML http://www.pharmtech.com/pharmtech/Test-01/ArticleStandard/Article/detail/758481?ref=25 Test 2012-02-01T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/062012/758481null HTML http://www.pharmtech.com/pharmtech/CSR/CSR-and-Sustainability-in-the-News/ArticleStandard/Article/detail/757267?ref=25 A roundup of developments in corporate social responsibility and sustainability from the bio/pharmaceutical industry, its suppliers, and other private and public organizations. 2012-02-01T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757267null HTML http://www.pharmtech.com/pharmtech/Strategies-for-Value-Creation-in-the-Biopharmaceut/ArticleStandard/Article/detail/757260?ref=25 Improving R&D productivity, life-cycle management, and operational efficiency are key approaches for enhancing growth prospects. 2012-02-01T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757260null HTML http://www.pharmtech.com/pharmtech/A-Mixed-Year-for-US-Biotech-Financing/ArticleStandard/Article/detail/757262?ref=25 Venture-capital financing was up last year in the US biotechnology industry, but public-equity financing, exclusive of debt, declined. 2012-02-01T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757262null HTML http://www.pharmtech.com/pharmtech/Isochem/ArticleStandard/Article/detail/757481?ref=25 Isochem offers Vitamin E TPGS NF Grade. 2012-02-01T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757481null PDF http://www.pharmtech.com/pharmtech/Drug+Delivery/Pointed-Debate-Expert-Views-on-Injectables/ArticleStandard/Article/detail/757201?ref=25 We bring industry experts together to discuss the importance of self-administration and what injection technologies are best suited to this cause. 2012-02-01T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/042012/757201null XML http://www.pharmtech.com/pharmtech/Industry+Leaders/Decoding-the-Hype-and-Fear-of-Nanomedicines/ArticleStandard/Article/detail/757197?ref=25 Does nanotechnology offer a cure-all or a kill all? We speak with Ruth Duncan about the real potential of nanomedicines. 2012-02-01T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/042012/757197null XML http://www.pharmtech.com/pharmtech/Outsourcing/Contract-Services-in-2012/ArticleStandard/Article/detail/757266?ref=25 Some recent private-equity buyouts of CROs show both the upside and downside for investors. 2012-02-01T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757266null XML http://www.pharmtech.com/pharmtech/Outsourcing/Outsourcing-to-Emerging-Markets-The-Effect-of-the-/ArticleStandard/Article/detail/757457?ref=25 Each developing economy has unique economic, political, and cultural issues that help define its pharmaceutical market. To succeed, multinational pharmaceutical companies will have to adapt differently. 2012-02-01T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757457/PTsupp0212_S34_95722386_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757457null XML http://www.pharmtech.com/pharmtech/Cliffhanger/ArticleStandard/Article/detail/757202?ref=25 "The patent expiry of several major blockbuster drugs worth $150 billion between 2010 and 2017 will fuel the growth of the global generic pharmaceuticals market," so says a press release announcing new analysis from Frost & Sullivan. 2012-02-01T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/042012/757202null XML http://www.pharmtech.com/pharmtech/Manufacturing/2012-A-Good-Bad-or-Ugly-Year-for-Servier/ArticleStandard/Article/detail/757200?ref=25 The scandal surrounding Servier's diabetes drug, Mediator, continues to unravel in France and could have implications for the whole pharmaceutical industry as the country scrutinises its regulatory systems. 2012-02-01T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/042012/757200null XML http://www.pharmtech.com/pharmtech/Ingredients/Case-Studies-in-Pharmaceutical-Project-Management/ArticleStandard/Article/detail/757458?ref=25 A technical forum featuring Catalent Pharma Solutions, SAFC, and Neuland Laboratories. 2012-02-01T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757458null XML http://www.pharmtech.com/pharmtech/Outsourcing/Evaluating-Competitive-Forces-in-Contract-Manufact/ArticleStandard/Article/detail/757460?ref=25 The author examines the opportunities and positioning of contract service providers. 2012-02-01T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757460/PTsupp0212_S30_ST000853_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757460null XML http://www.pharmtech.com/pharmtech/Outsourcing/Managing-the-Quality-Relationship-for-a-Contractua/ArticleStandard/Article/detail/757456?ref=25 The author describes an equation that can be used to define the Quality relationship between a contract manufacturing organization and a client, including how to factor in both party's needs and regulatory commitments. 2012-02-01T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/052012/757456null XML http://www.pharmtech.com/pharmtech/Analytics/SAXS-helps-understanding-Allergies/ArticleStandard/Article/detail/741713?ref=25 In this study the crosslinking of an allergenic monomer was investigated with the SAXSess small-angle X-ray scattering system in order to understand the triggering step of an allergen. 2012-02-01T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/402011/741713null REMOTE http://www.pharmtech.com/pharmtech/IT/Head-in-the-Clouds/ArticleStandard/Article/detail/757203?ref=25 We interview Subhro Mallik from IT firm Infosys about how pharma is responding to the cloud computing phenomenon and what more can be done to realise business benefits. 2012-02-01T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/042012/757203null XML http://www.pharmtech.com/pharmtech/Manufacturing/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. 2012-02-01T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/222011/724253null REMOTE http://www.pharmtech.com/pharmtech/Superior-quality-pipettes-for-endotoxin-testing/ArticleStandard/Article/detail/707985?ref=25 Sterilin single-use, serological pipettes are certified non-pyrogenic to a lower level than ever before (0.01EU/ml), making them ideal for pharmaceutical and medical device manufacturers to use when ensuring that their products are free from endotoxin contamination. Available in a wide variety of sizes, they are gamma irradiated and individually wrapped to ensure quality and reliability. 2012-01-27T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/082011/707985null HTML http://www.pharmtech.com/pharmtech/SPECIALITY-CHEMICALS-MANUFACTURING-FACILITY-151-FO/ArticleStandard/Article/detail/756703?ref=25 On the instruction of Clariant, a global leader in the manufacture of speciality chemicals, the Cardiff office of Jones Lang LaSalle has been instructed to market a 'speciality chemicals' manufacturing facility in Church Village, near Cardiff, South Wales, UK. 2012-01-27T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/032012/756703null HTML http://www.pharmtech.com/pharmtech/Company+and+People+Notes/Week-of-Jan-23-2012-2012-Facility-of-the-Year-Awar/ArticleStandard/Article/detail/757075?ref=25 2012 Facility of the Year Awards are Announced; Suzhou Pharma Services Names Oliver Mueller President; and More. 2012-01-26T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/042012/757075null HTML http://www.pharmtech.com/pharmtech/News/Genzyme-Plant-Approved-to-Begin-Manufacture-of-Dru/ArticleStandard/Article/detail/756948?ref=25 Sanofi's subsidiary Genzyme has received FDA's approval for the production of Fabrazyme (agalsidase beta), used in the treatment of Fabry's disease, at its manufacturing facility in Framingham, Massachusetts. Shortages of Fabrazyme have been ongoing for the past two years. 2012-01-26T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/042012/756948null HTML http://www.pharmtech.com/pharmtech/News/European-Outsourcing-Revenue-to-Grow-by-50/ArticleStandard/Article/detail/756962?ref=25 According to a report from Frost & Sullivan, the European pharmaceutical contract manufacturing market could earn revenues of up to $20.75 billion in 2018, almost double that of 2011's revenue when the market earned $10.02 billion. Over the same period, the European market for biotechnology outsourcing is forecast to grow from $1.21 billion to $2.67 billion. 2012-01-26T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/042012/756962null HTML http://www.pharmtech.com/pharmtech/Online+Only/Call-for-Funding-to-End-Animal-Experiments/ArticleStandard/Article/detail/756965?ref=25 As the EU debates how best to spend billions of euros worth of research funding, the Humane Society International/Europe has issued a call to develop in vitro and computational techniques that can replace the use of animals in medical experiments. 2012-01-26T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/042012/756965null HTML http://www.pharmtech.com/pharmtech/News/EMA-Releases-Pharmacogenomics-Concept-Paper/ArticleStandard/Article/detail/756970?ref=25 The EMA has released a concept paper for a guideline on pharmacogenomic methodologies in the evaluation of authorized medicines to address the fact that genetic differences can cause variability in drug therapy efficacy and safety. 2012-01-26T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/042012/756970null HTML http://www.pharmtech.com/pharmtech/MS-drug-personalised-with-risk-diagnostic/ArticleStandard/Article/detail/757009?ref=25 The FDA has approved a safety label change for Biogen and Elan?s multiple sclerosis drug Tysabri identified a diagnostic test that can help identify patients at risk of developing a serious brain infection, which has been associated with the drug. 2012-01-25T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/042012/757009null HTML http://www.pharmtech.com/pharmtech/Standards+%26+Regulation/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. 2012-01-24T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/382011/739321null REMOTE http://www.pharmtech.com/pharmtech/Manufacturing/An-Introduction-to-Pharmaceutical-Forensics/ArticleStandard/Article/detail/748864?ref=25 Pharmaceutical forensics applies forensic expertise, analysis and problem solving principles to address quality issues such nonconformance and deviation investigations, contaminant identification and source determination. This whitepaper provides an introduction to this approach and a case study example of particulate examination. 2012-01-24T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/472011/748864null REMOTE http://www.pharmtech.com/pharmtech/Whitepapers/New-UV-Intensity-Multiplication-Technology-dramati/ArticleStandard/Article/detail/753896?ref=25 This paper presents a review of existing air sterilization techniques and describes an innovative new technology that provides levels of air sterilization not previously achievable. The technology provides a breakthrough capability for supplying sterile air for biopharmaceutical manufacturing, clean room, hospital, bio containment and defense applications. 2012-01-24T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/522011/753896null REMOTE http://www.pharmtech.com/pharmtech/Whitepapers/Not-all-ELN-IP-Protection-Controls-are-EqualndashW/ArticleStandard/Article/detail/741711?ref=25 Using an electronic lab notebook (ELN) or planning to move to one? More laboratories and R&D-centric organizations are changing from paper-based to electronic workflows to remain competitive…and why not? From initial conceptualization through product development and production, ELNs and other lab informatics systems are efficient and effective for what they are designed to do. 2012-01-24T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/402011/741711null REMOTE 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. 2012-01-24T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/362011/738098null REMOTE http://www.pharmtech.com/pharmtech/Standards+%26+Regulation/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. 2012-01-24T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/042012/757064null REMOTE http://www.pharmtech.com/pharmtech/Standards+%26+Regulation/Streamlined-Approach-for-Nasal-Spray-Product-Devel/ArticleStandard/Article/detail/757063?ref=25 This white paper will provide a comprehensive overview of the CMC guidance by the U.S. Food and Drug Administration and present a streamlined approach for development and manufacture of nasal spray products. 2012-01-24T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/042012/757063null REMOTE http://www.pharmtech.com/pharmtech/Whitepapers/ROTRONICrsquos-New-Technology-Reduces-Calibration-/ArticleStandard/Article/detail/754114?ref=25 Maintaining the accuracy of your humidity and temperature instruments requires periodic calibration. Calibration of these instruments can be a costly and time-consuming venture. ROTRONIC’s new AIRCHIP 3000 Digital technology greatly reduces calibration time and cost by eliminating one full calibration cycle. 2012-01-24T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/532011/754114null REMOTE http://www.pharmtech.com/pharmtech/Standards+%26+Regulation/How-to-Avoid-and-Respond-to-FDA-483s/ArticleStandard/Article/detail/738111?ref=25 The following article shows excerpts from some common observations in Form 483 Letters. After the excerpts, we outline 10 best practices of a 483 response including links to further resources. Then we discuss different methods of monitoring, alarming and reporting critical parameters like temperature and humidity in FDA regulated environments and how to avoid deviations from cGMP in your regulated environments. 2012-01-24T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/362011/738111null REMOTE http://www.pharmtech.com/pharmtech/Manufacturing/Seven-Secrets-to-a-Successful-Auction/ArticleStandard/Article/detail/737917?ref=25 Have you been elected to close your facility? Or do you have idle assets in your facility that need clearance? Selecting the right auction partner can be difficult. We created a Better Auctions Resource Center and an eBook, “Seven Secrets to a Successful Auction”, as tools to guide you through this process. 2012-01-24T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/362011/737917null REMOTE http://www.pharmtech.com/pharmtech/News/Genentech-Backs-Epigenetics/ArticleStandard/Article/detail/756571?ref=25 Constellation Pharmaceuticals announced that it has entered into a broad collaboration with Genentech, a member of the Roche group, to discover and develop innovative treatments based on epigenetics, which focuses on the identification of small molecule inhibitors of protein activity. 2012-01-20T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/032012/756571null HTML http://www.pharmtech.com/pharmtech/High-quality-pharmaceutical-packaging-products/ArticleStandard/Article/detail/707989?ref=25 Sterilin high quality plastic packaging products are ideal for storing and transporting a wide range of pharmaceutical products. Manufactured from FDA approved materials, the range includes a large variety of shapes and sizes, and offers a wide range of different caps and closures to suit the needs every customer. 2012-01-20T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/082011/707989null HTML http://www.pharmtech.com/pharmtech/News/Takeda-to-Axe-2100-Jobs-in-Europe/ArticleStandard/Article/detail/756615?ref=25 Takeda has announced "strategic measures to achieve efficiencies for long-term growth", which includes cutting close to 3000 jobs, 2100 of which will come from Europe. 2012-01-20T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/032012/756615null HTML http://www.pharmtech.com/pharmtech/Company+and+People+Notes/Week-of-Jan-16-2012-Takeda-Restructures-Savient-Ph/ArticleStandard/Article/detail/756586?ref=25 Takeda Restructures; Savient Pharmaceuticals Names David Veitch President of Savient Europe; and More. 2012-01-19T05:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/032012/756586null HTML