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. 2013-05-22T02:29:50Z http://www.pharmtech.com/pharmtech/Nichebusters-a-New-Model-for-Drug-Development-Driv/ArticleStandard/Article/detail/813256?ref=25 The growing demand for targeted biopharmaceutical therapies is driving interest in modular production facilities that can be rapidly constructed while still minimizing risk and cost. 2013-05-22T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813256null HTML http://www.pharmtech.com/pharmtech/Raising-the-Bar-in-Tablet-Coating-Equipment-and-Pr/ArticleStandard/Article/detail/813265?ref=25 Greater automation and the adoption of solid versus perforated pans are some recent advances. 2013-05-22T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813265null HTML http://www.pharmtech.com/pharmtech/Liquid-Nitrogen-Cooling-Systems-Advantageous-for-L/ArticleStandard/Article/detail/813259?ref=25 Access to extremely low and consistently controlled reaction temperatures can improve product yields and selectivities while also reducing costs. 2013-05-22T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813259null HTML http://www.pharmtech.com/pharmtech/The-Next-Generation-in-Aseptic-Filling-Equipment/ArticleStandard/Article/detail/813263?ref=25 Adoption of single-use systems and more flexible systems drive innovation. 2013-05-22T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813263null HTML http://www.pharmtech.com/pharmtech/Multivariate-Approaches-for-Powder-Characterizatio/ArticleStandard/Article/detail/813264?ref=25 Dynamic testing and advances in shear testing provide better insight into powder physical properties and external variables that affect powder behavior. 2013-05-22T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813264null HTML http://www.pharmtech.com/pharmtech/Vaisala---Conduct-Better-Stability-Studies-Reduce-/ArticleStandard/Article/detail/813832?ref=25 Vaisala - Conduct Better Stability Studies: Reduce the Risk of Incomplete Records 2013-05-21T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/212013/813832null HTML http://www.pharmtech.com/pharmtech/News/AbbVie-and-Galapagos-Extend-GLPG0634-Collaboration/ArticleStandard/Article/detail/813711?ref=25 AbbVie and Galapagos have extended their collaboration on the clinical development of GLPG0634 to include Crohn's disease. 2013-05-21T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/212013/813711null HTML http://www.pharmtech.com/pharmtech/News/USP-Offers-Herbal-Medicines-Compendium/ArticleStandard/Article/detail/813817?ref=25 The U.S. Pharmacopeial Convention is offering free online access to public standards to help ensure the quality of the herbal ingredients used in medicinal products. 2013-05-20T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/212013/813817null HTML http://www.pharmtech.com/pharmtech/News/Actavis-to-Acquire-Warner-Chilcott/ArticleStandard/Article/detail/813797?ref=25 Actavis Inc. and Warner Chilcott plc have entered into a definitive agreement under which Actavis will acquire Warner Chilcott plc in a stock-for-stock transaction valued at approximately $8.5 billion. 2013-05-20T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/212013/813797null HTML http://www.pharmtech.com/pharmtech/News/AstraZeneca-Provides-Update-on-Oncology-Pipeline/ArticleStandard/Article/detail/813708?ref=25 AstraZeneca announced that three of its cancer compounds—moxetumomab pasudotox, olaparib and selumetinib—will be moving forward to Phase III clinical development. Oncology is one of the company's core therapy areas and accelerating the development of a number of new molecular entities in its pipeline is a strategic priority. 2013-05-20T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/212013/813708null HTML http://www.pharmtech.com/pharmtech/Setting-new-Benchmarks-for-Antibody-Analysis/ArticleStandard/Article/detail/813529?ref=25 Tosoh Bioscience expands the renowned TSKgel SW series of aqueous size exclusion HPLC columns by three new UHPLC columns, tailored to different aspects of antibody analysis. 2013-05-17T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813529null HTML http://www.pharmtech.com/pharmtech/Online+Only/NEW-genderless-connectors-for-innovative-sterile-c/ArticleStandard/Article/detail/813525?ref=25 Colder?s new genderless AseptiQuik® G Connectors make single-use sterile connections faster, easier and safer?even in non-sterile conditions. Universal mating simplifies systems integration, increases process flexibility and minimizes operator error. 2013-05-17T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813525null HTML http://www.pharmtech.com/pharmtech/Legislation-to-Protect-Subjects-in-Clinical-Trials/ArticleStandard/Article/detail/813818?ref=25 Legislation designed to protect clinical trial study participants, close loopholes, and bring certainty and public transparency to research studies, has been introduced. 2013-05-16T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/212013/813818null HTML http://www.pharmtech.com/pharmtech/Editor%27s+Picks/May-2013-Editors-Picks-Products-from-Romaco-and-LB/ArticleStandard/Article/detail/812822?ref=25 Products from Romaco and L.B. Bohle. 2013-05-15T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192013/812822null HTML http://www.pharmtech.com/pharmtech/Troubleshooting/Measuring-Tablet-Hardness-A-Primer/ArticleStandard/Article/detail/812820?ref=25 Crushing, fracturing, and bending tests quantify hardness. 2013-05-15T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192013/812820null HTML http://www.pharmtech.com/pharmtech/News/AbbVie-and-Alvine-Will-Collaborate-on-Celiac-Disea/ArticleStandard/Article/detail/813311?ref=25 Program aims to develop a novel oral treatment. 2013-05-15T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813311null HTML http://www.pharmtech.com/pharmtech/News/Theravance-and-Elan-Enter-1-Billion-Royalty-Partic/ArticleStandard/Article/detail/813310?ref=25 Elan will purchase interest in four respiratory programs. 2013-05-15T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813310null HTML http://www.pharmtech.com/pharmtech/News/Report-Previews-Future-of-US-Biosimilar-Market/ArticleStandard/Article/detail/813821?ref=25 Thomson Reuters released a report that provides a view of the challenges facing companies entering the United States biosimilar drug market. 2013-05-15T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/212013/813821null HTML http://www.pharmtech.com/pharmtech/Production+Lines/Experts-at-INTERPHEX-Discuss-Quality-by-Design/ArticleStandard/Article/detail/812819?ref=25 Making the effort to apply new methods to pharmaceutical processing will bring benefits. 2013-05-15T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192013/812819null HTML http://www.pharmtech.com/pharmtech/Packaging+%26+Labeling/INTERPHEX-Highlights-Serialization/ArticleStandard/Article/detail/812821?ref=25 Integrated serialization systems keep pace with industry demand. 2013-05-15T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192013/812821null HTML http://www.pharmtech.com/pharmtech/News/FDA-Issues-Pharmacoepidemiologic-Safety-Study-Guid/ArticleStandard/Article/detail/813184?ref=25 FDA has released guidance on best practices for conducting and reporting pharmacoepidemiologic safety studies. 2013-05-14T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813184null HTML http://www.pharmtech.com/pharmtech/News/Biotage-Responds-to-CEM-Corporation-Patent-Dispute/ArticleStandard/Article/detail/813296?ref=25 Biotage issued a statement in response to a recent announcement from CEM Corporation about a patent issue with Biotage. 2013-05-13T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813296null HTML http://www.pharmtech.com/pharmtech/News/Lillys-Enzastaurin-Disappoints-in-Phase-III-Trial/ArticleStandard/Article/detail/812961?ref=25 Eli Lilly reported that enzastaurin did not meet the primary endpoint in a Phase III study, which evaluated the agent as a monotherapy for the prevention of relapse in patients with diffuse large B-cell lymphoma (DLBCL). 2013-05-13T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/812961null HTML http://www.pharmtech.com/pharmtech/Online+Only/Amgen-Forms-New-Joint-Venture-to-Commercialize-Vec/ArticleStandard/Article/detail/812960?ref=25 Amgen and Zhejiang Beta Pharma have signed an agreement to form a joint venture to commercialize Amgen's Vectibix (panitumumab) in the Chinese market. The aim is to quickly and efficiently deliver Vectibix to patients in China. Vectibix is a fully human anti-epidermal growth factor receptor (EGFR) antibody approved by FDA for the treatment of metastatic colorectal cancer. 2013-05-13T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/812960null HTML http://www.pharmtech.com/pharmtech/News/USP-Launches-Initiative-to-Fight-Counterfeit-Drugs/ArticleStandard/Article/detail/813066?ref=25 New Center for Pharmaceutical Advancement and Training increases number of experts and available tools in Sub-Saharan countries. 2013-05-13T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813066null HTML http://www.pharmtech.com/pharmtech/News/Takeda-to-Acquire-Inviragen-for-up-to-250-Million/ArticleStandard/Article/detail/812838?ref=25 Takeda and US vaccines maker Inviragen jointly announced that they have entered into a definitive agreement for Takeda to acquire Inviragen for an upfront payment of US$35 million and future payments of up to US$215 million upon achievement of key commercial milestones, linked to the progress of clinical development. 2013-05-10T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192013/812838null HTML http://www.pharmtech.com/pharmtech/News/GSK-Announces-Plans-to-Share-Clinical-Trial-Data/ArticleStandard/Article/detail/812739?ref=25 In its commitment to transparency, GlaxoSmithKline (GSK) has outlined plans to share detailed data from its clinical trials. GSK is to establish a new online system that will enable researchers to request access to anonymised patient level data. 2013-05-09T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192013/812739null HTML http://www.pharmtech.com/pharmtech/Company+and+People+Notes/CEM-Wins-Peptide-Patent-Dispute-with-Biotage/ArticleStandard/Article/detail/812900?ref=25 CEM Corp. announced that its European Patent covering microwave assisted solid phase peptide synthesis has been upheld. 2013-05-09T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192013/812900null HTML http://www.pharmtech.com/pharmtech/Nexera-X2--X-ceptional-insights/ArticleStandard/Article/detail/812812?ref=25 Ultra-high sensitivity, expanded flexibility, increased stability and robustness - the new Nex-era X2 UHPLC system targets routine analysis and applications in highly regulated environ-ments demanding complex system setups 2013-05-09T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192013/812812null HTML http://www.pharmtech.com/pharmtech/Carbon-14-Bioconjugation-Peptides-and-Antibody-Dru/ArticleStandard/Article/detail/812243?ref=25 The authors explain how the synergy between peptide and protein technology and radiolabeling groups can enable the manufacture of carbon-14 labeled peptides and antibody-drug conjugates. 2013-05-08T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182013/812243null HTML http://www.pharmtech.com/pharmtech/Roche-Engineer-wins-iPad-at-INTERPHEX/ArticleStandard/Article/detail/812334?ref=25 Roche Engineer wins iPad at INTERPHEX 2013-05-08T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182013/812334null HTML http://www.pharmtech.com/pharmtech/Online+Only/USP-Workshop-Addresses-Moisture-Permeation-Into-Pa/ArticleStandard/Article/detail/812718?ref=25 The workshop will cover a proposed new method for measuring moisture vapor transmission rate. 2013-05-08T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192013/812718null HTML http://www.pharmtech.com/pharmtech/Company+and+People+Notes/SCHOTT-Doubles-Production-Capacity-for-Polymer-Syr/ArticleStandard/Article/detail/812719?ref=25 New line in Swiss facility produces ready-to-fill syringes. 2013-05-08T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192013/812719null HTML http://www.pharmtech.com/pharmtech/Biologics/Improving-the-Economics-of-Monoclonal-Antibody-Sep/ArticleStandard/Article/detail/812242?ref=25 Advances in monoclonal antibody separation technologies are largely driven by the need to increase efficiencies and reduce cost. 2013-05-08T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182013/812242null HTML http://www.pharmtech.com/pharmtech/Orally-Disintegrating-Tablets/ArticleStandard/Article/detail/812319?ref=25 Drug manufacturers today are increasingly challenged to find new, effective methods for the delivery of active pharmaceutical ingredients, and many are discovering that orally disintegrating technologies can help. 2013-05-08T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182013/812319null HTML http://www.pharmtech.com/pharmtech/Orally-Disintegrating-Technology-Provides-Both-For/ArticleStandard/Article/detail/812254?ref=25 Drug manufacturers today are increasingly challenged to find new, effective methods for the delivery of active pharmaceutical ingredients, and many are discovering that orally disintegrating technologies can help. 2013-05-08T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182013/812254null HTML http://www.pharmtech.com/pharmtech/Advances-in-Biodegradable-Polymer-Technologies-Fac/ArticleStandard/Article/detail/812241?ref=25 New platform technologies and polymer chemistries may facilitate self-administration, longer-term delivery, and targeted delivery of parenteral drugs. 2013-05-08T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182013/812241null HTML http://www.pharmtech.com/pharmtech/Optimizing-the-Selection-of-Mixing-Equipment/ArticleStandard/Article/detail/810952?ref=25 Effective blenders provide efficient, homogeneous mixing and de-aeration for a wide range of formulations 2013-05-08T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/162013/810952null HTML http://www.pharmtech.com/pharmtech/News/European-Medicines-Agency-Changes-Procedures-for-O/ArticleStandard/Article/detail/812698?ref=25 EMA streamlines orphan drug application procedure. 2013-05-08T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192013/812698null HTML http://www.pharmtech.com/pharmtech/Advances-in-Ion-Exchange-Chromatography-Leading-to/ArticleStandard/Article/detail/812252?ref=25 New ion-exchange chromatography media are more tolerant of varying conditions, making it possible to eliminate process steps. 2013-05-08T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182013/812252null HTML http://www.pharmtech.com/pharmtech/Tamiflu-Leads-Q1-Drug-Sales-Growth/ArticleStandard/Article/detail/812541?ref=25 In the first quarter of 2013, the rankings for the top five drugs by sales shifted a bit, but exhibited positive growth for the quarter. 2013-05-07T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192013/812541null HTML http://www.pharmtech.com/pharmtech/New-Technique-for-Environmental-Monitoring-in-Clea/ArticleStandard/Article/detail/812253?ref=25 TSI's BioTrak Real-Time Viable Particle Counter, provide Quality Assurance professionals with additional, valuable information to find root causes of viable and non-viable particle excursions. 2013-05-07T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182013/812253null HTML http://www.pharmtech.com/pharmtech/Most+Viewed+Articles/Pfizer-Opens-Online-Pharmacy-to-Fight-Counterfeit-/ArticleStandard/Article/detail/812543?ref=25 Pfizer has launched a prescription-fulfillment website for Viagra tablets in an effort to combat the online sale of counterfeited medicine. 2013-05-06T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192013/812543null HTML http://www.pharmtech.com/pharmtech/Big-Pharmas-Investment-in-Biologics/ArticleStandard/Article/detail/811803?ref=25 Bristol-Myers Squibb, Novartis, GlaxoSmithKline, Sanofi, and Roche are among the companies expanding biologic-based manufacturing capacity. 2013-05-03T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182013/811803null HTML http://www.pharmtech.com/pharmtech/Strategic-Partnering-for-Manufacturing/ArticleStandard/Article/detail/811818?ref=25 Eisai and Biogen Idec pursue an innovative approach to capacity management. 2013-05-03T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182013/811818null HTML http://www.pharmtech.com/pharmtech/Most+Viewed+Articles/The-New-Normal-In-Biotech-Financing/ArticleStandard/Article/detail/811804?ref=25 Financing to biotech companies in North American and Europe declined in 2012 as debt funding decreased and the IPO market remained weak. 2013-05-03T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182013/811804null HTML http://www.pharmtech.com/pharmtech/Pharma-News-in-Global-Health-and-Sustainability/ArticleStandard/Article/detail/811821?ref=25 A roundup of developments in global health and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations. 2013-05-03T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182013/811821null HTML http://www.pharmtech.com/pharmtech/CSR/Pharma-Industry-Participates-in-Vaccine-Initiative/ArticleStandard/Article/detail/811822?ref=25 The Global Vaccine Action plan maps out a strategy to increase access and R&D for vaccines. 2013-05-03T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182013/811822null HTML http://www.pharmtech.com/pharmtech/Orally-Disintegrating-Tablets/ArticleStandard/Article/detail/812317?ref=25 Podcast interview with Nick Johnson, Strategic Marketing Director for Modified Release Technologies at Catalent Pharma Solutions 2013-05-03T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182013/812317null HTML http://www.pharmtech.com/pharmtech/Feature+Articles/Lyophilization-A-Primer/ArticleStandard/Article/detail/813407?ref=25 Optimized freeze-drying cycles can offer scientific and business advantages. 2013-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813407/0513_primer_thumb_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813407null XML http://www.pharmtech.com/pharmtech/Ingredients+Insider/Intellectual-Property-Battles-in-Solid-State-Chemi/ArticleStandard/Article/detail/813405?ref=25 The rejection by India's Supreme Court on Novartis' Glivec/Gleevec (imatinib mesylate) and other recent case law raise important issues on patent strategies for solid forms. 2013-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813405/pt0513_api_thumb_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813405null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Facility-Trends-Modularization-and-Single-Use/ArticleStandard/Article/detail/813398?ref=25 Pharmaceutical Technology spoke with INTERPHEX 2013 conference-session presenters to gain insight on trends in facility and process design. 2013-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813398null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Enhancing-Particle-Size-Measurement-Using-Dry-Lase/ArticleStandard/Article/detail/813408?ref=25 The author examines dry dispersion and outlines the related analytical method development. 2013-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813408/pt0513_prmalvern_thumg_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813408null XML http://www.pharmtech.com/pharmtech/Outsourcing+Outlook/Outsourcings-Modest-Role-as-a-Cost-Containment-Str/ArticleStandard/Article/detail/813399?ref=25 Outsourcing is weighing in more as a tactic for cost-cutting, but it is still not the primary weapon. 2013-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813399null XML http://www.pharmtech.com/pharmtech/BioForum/ZFN-Technology-Advances-Biopharmaceutical-Manufact/ArticleStandard/Article/detail/813410?ref=25 Applications of ZFN technology in biopharmaceutical cell-line engineering. 2013-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813410null XML http://www.pharmtech.com/pharmtech/From+the+Editor/Pathway-to-Publication/ArticleStandard/Article/detail/813394?ref=25 Wanted: Article contributions on drug and process development topics. 2013-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813394null XML http://www.pharmtech.com/pharmtech/Regulatory+Corner/Should-Regulation-of-Combination-Products-Become-M/ArticleStandard/Article/detail/813403?ref=25 While there are those who want combination products to be controlled by a centralized pharmaceutical-type approval system, the majority of the medical technology industry wants to retain a decentralized device-focused approach. 2013-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813403null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Understanding-ICH-Q11mdashFDAs-Guidance-on-the-Dev/ArticleStandard/Article/detail/813396?ref=25 The author provides a review of FDA's guidance document, Guidance for Industry: Q11 Development and Manufacture of Drug Substances, and its relation to the International Conference on Harmonization's Q11 document and its application to the industry. 2013-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813396null XML http://www.pharmtech.com/pharmtech/FDA-Expectations-for-Supplier-Management/ArticleStandard/Article/detail/813401?ref=25 James Stumpff, Principal Consultant at PAREXEL discusses supplier management and FDA's expectations. 2013-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813401null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Prefilled-Syringes-or-Peptide-Pills/ArticleStandard/Article/detail/813404?ref=25 The impact of new delivery technologies in designing peptide therapies. 2013-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813404/pt0513_pharm_thumb_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813404null XML http://www.pharmtech.com/pharmtech/Ingredients/Using-Thermal-Ink-Jet-Printing-Technology-to-Produ/ArticleStandard/Article/detail/813397?ref=25 Cocrystals are used to improve the performance of APIs that have non-ideal physiochemical properties by cocrystallizing the API with a second compound that modulates the API to provide a way to improve a drug's bioavailability, stability, and processability. 2013-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813397null XML http://www.pharmtech.com/pharmtech/Statistical+Solutions/Compositing-Samples-and-the-Risk-to-Product-Qualit/ArticleStandard/Article/detail/813392?ref=25 Compositing samples is appropriate under certain circumstances but raises caveats on how and when it should be applied. 2013-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813392null XML http://www.pharmtech.com/pharmtech/Industry+Leaders/QampA-with-Stuart-E-Needleman-Aptuit/ArticleStandard/Article/detail/813406?ref=25 A Q&A with Stuart E. Needleman, President and Chief Operating Officer of Aptuit, on recent industry trends. 2013-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813406/needleman_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813406null XML http://www.pharmtech.com/pharmtech/Troubleshooting/Using-a-Gravimetric-Feeder-to-Dose-Pharmaceutical-/ArticleStandard/Article/detail/813395?ref=25 Loss-in-weight feeders provide high accuracy for batch or continuous processes. 2013-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813395null XML http://www.pharmtech.com/pharmtech/Ingredients/Academic-and-Public-Partnerships-in-Solid-State-Ch/ArticleStandard/Article/detail/813400?ref=25 Solid-state chemistry is an important part of drug development, and public research is advancing the field. 2013-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813400null XML http://www.pharmtech.com/pharmtech/Regulatory+Corner/Regulatory-Convergence-Sought-for-Global-Pharma-Ma/ArticleStandard/Article/detail/813412?ref=25 Manufacturers work with international authorities to harmonize drug registration and supply-chain oversight. 2013-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813412null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Co-Opetition-in-Drug-Development/ArticleStandard/Article/detail/813391?ref=25 The author suggests co-opetition as a future model for collaboration in drug development. 2013-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813391null XML http://www.pharmtech.com/pharmtech/Regulatory+Corner/Regulatory-Roundup/ArticleStandard/Article/detail/813487?ref=25 FDA faces budget crunch; Supreme Court hears key cases 2013-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813487null XML http://www.pharmtech.com/pharmtech/Standards+%26+Regulation/Report-from-Brazil/ArticleStandard/Article/detail/813393?ref=25 Prior to price escalation of pharmaceutical products in Brazil, the country's regulatory authority released a study on price-cap control and its benefits in the past years. 2013-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813393null XML http://www.pharmtech.com/pharmtech/NEW-genderless-connectors-for-innovative-sterile-c/ArticleStandard/Article/detail/812264?ref=25 Colder?s new genderless AseptiQuik? G Connectors make single-use sterile connections faster, easier and safer?even in non-sterile conditions. Universal mating simplifies systems integration, increases process flexibility and minimizes operator error. 2013-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182013/812264null HTML http://www.pharmtech.com/pharmtech/Feature+Articles/New-First-to-File-Patent-Rule-Threatens-Open-Colla/ArticleStandard/Article/detail/813409?ref=25 New US patent rules change the playing field for open innovation. 2013-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813409null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Controlling-Ice-Nucleation-During-the-Freezing-Ste/ArticleStandard/Article/detail/813411?ref=25 Lyophilization technologies for controlled nucleation. 2013-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813411/pt0513_cvs_thumb_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813411null XML http://www.pharmtech.com/pharmtech/Industry+Insider/Campaign-Against-Counterfeit-Drugs-Continues/ArticleStandard/Article/detail/813491?ref=25 Drug companies team up with INTERPOL to keep counterfeit medicines off the Internet and out of the hands of patients. 2013-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813491null XML http://www.pharmtech.com/pharmtech/In+the+Spotlight/Product-Spotlight-AutomationITProcess-Control/ArticleStandard/Article/detail/813402?ref=25 New product reviews for May 2013, featuring automation, IT, and process control systems. 2013-05-02T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/202013/813402null XML http://www.pharmtech.com/pharmtech/News/Pharmaco-Kinesis-Corporation-Develops-First-Nanodr/ArticleStandard/Article/detail/812032?ref=25 Pharmaco-Kinesis Corporation (PKC) announced that it is developing the first nanodrug combination of Merck's temozolomide and Celgene's thalidomide (in a 50:50 ratio) for the treatment of gliomas and other cancers. PKC will collaborate with the University of California, San Diego's department of nano-engineering at the Moores cancer centre to develop the nanodroplet formulation. 2013-05-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182013/812032null HTML http://www.pharmtech.com/pharmtech/Feature+Articles/Delivering-Complex-Drugs-With-Nanotechnology-Based/ArticleStandard/Article/detail/812591?ref=25 Parenteral drug delivery offers a variety of challenges but also opportunities. The author examines recent developments in nanotechnology-based drug delivery and other advances in injection-based drug delivery. 2013-05-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192013/812591/pts0513_forum_t_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192013/812591null XML http://www.pharmtech.com/pharmtech/Whitepapers/OPC-The-Ins-and-Outs-to-What-Its-About/ArticleStandard/Article/detail/812058?ref=25 The Every Man's Guide to OPC is an easy-to-read overview of the most popular industrial open connectivity standar - OPC. This paper first introduces the main idea behind OPC, shows why OPC is different from conventional (often proprietary) communication protocols, and explains how OPC helps overcome the limitations of such native protocols. 2013-05-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182013/812058null REMOTE http://www.pharmtech.com/pharmtech/News/Actemra-Receives-FDA-Approval-for-Polyarticular-Ju/ArticleStandard/Article/detail/812031?ref=25 Genentech announced that FDA has approved Actemra (tocilizumab) for the treatment of polyarticular juvenile idiopathic arthritis (PJIA) in children aged two years and older. 2013-05-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182013/812031null HTML http://www.pharmtech.com/pharmtech/Feature+Articles/Risk-Mitigation-and-Microbial-Control-and-Monitori/ArticleStandard/Article/detail/812584?ref=25 A control strategy can maintain a low level of particulates, and thereby a low bioburden, in cleanrooms 2013-05-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192013/812584null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Big-Pharmas-Manufacturing-Investments-in-Biologics/ArticleStandard/Article/detail/812582?ref=25 Despite overall manufacturing rationalization in the pharmaceutical/biopharmaceutical industry, the large pharmaceutical companies continue to invest in biologic-based manufacturing. The author provides an update in recent investment activity among the pharmaceutical majors in biologic-drug substance, vaccine, and parenteral drug manufacturing. 2013-05-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192013/812582/pst0513_bio_t_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192013/812582null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Applying-Continuous-Flow-Pasteurization-and-Steril/ArticleStandard/Article/detail/812590?ref=25 High-temperature, short-time (HTST) pasteurization and ultra-high temperature (UHT) sterilization are potentially useful as part of the trend toward methods of continuous manufacturing of bio/pharmaceuticals. 2013-05-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192013/812590null XML http://www.pharmtech.com/pharmtech/Drug+Delivery/Advancing-Drug-Delivery-for-Parenteral-Application/ArticleStandard/Article/detail/812592?ref=25 Researchers recently developed a drug-delivery system to mitigate problems associated with jet-injection drug delivery, and also improved on the design and operation of microscale actuators as a possible drug-delivery method. 2013-05-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192013/812592null XML http://www.pharmtech.com/pharmtech/Feature+Articles/An-Integrated-Prefilled-Syringe-Platform-Approach-/ArticleStandard/Article/detail/812737?ref=25 The authors describe a holistic and integrated approach to focus on the linkage of the prefilled syringe with the four phases of product design, development, operation, and control. 2013-05-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192013/812737/pts0513_vaccine_t_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192013/812737null XML http://www.pharmtech.com/pharmtech/Feature+Articles/Containment-Verification-Testing-For-Pharmaceutica/ArticleStandard/Article/detail/812735?ref=25 A Good Practice Guide from the International Society of Pharmaceutical Engineering provides a framework to assess how well pharmaceutical equipment contains hazardous APIs. 2013-05-01T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192013/812735/PTs0515_contain_t_thumbnail.jpg http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/192013/812735null XML http://www.pharmtech.com/pharmtech/Online+Only/PerkinElmer-Announces-Collaboration-with-Chinas-Na/ArticleStandard/Article/detail/811913?ref=25 A personalized drug research and development platform will validate biomarkers for individualized disease treatment for Chinese patients. 2013-04-30T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182013/811913null HTML http://www.pharmtech.com/pharmtech/Whitepapers/Protein-Separation-with-pH-Gradients-Using-Composi/ArticleStandard/Article/detail/811991?ref=25 Tips and tricks on how to correctly apply the Agilent Buffer Advisor Software for the generation of pH gradients over a wide range using composite buffer systems. 2013-04-30T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/biopharm/182013/811991null REMOTE http://www.pharmtech.com/pharmtech/Company+and+People+Notes/Malvern-Instruments-and-Netzsch-Grinding-amp-Dispe/ArticleStandard/Article/detail/811914?ref=25 Marketing agreement involves particle-sizing and milling equipment. 2013-04-30T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182013/811914null HTML http://www.pharmtech.com/pharmtech/News/Bayer-to-Acquire-Conceptus-for-US11-Billion/ArticleStandard/Article/detail/812030?ref=25 Bayer announced that it has signed a merger agreement with US-based birth-control specialist Conceptus. 2013-04-30T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182013/812030null HTML http://www.pharmtech.com/pharmtech/Company+and+People+Notes/Uhlmann-Group-Spins-Off-visiotec-GmbH/ArticleStandard/Article/detail/811915?ref=25 New company will focus on inspection, monitoring, and control systems for automated pharmaceutical manufacturing processes. 2013-04-30T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182013/811915null HTML http://www.pharmtech.com/pharmtech/Matrikon---OPC-The-Ins-and-Outs-to-What-Its-About/ArticleStandard/Article/detail/811823?ref=25 Matrikon - OPC: The Ins and Outs to What It's About 2013-04-29T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/182013/811823null HTML http://www.pharmtech.com/pharmtech/Metrics---USING-QUALITY-BY-DESIGN-TO-IMPROVE-STREN/ArticleStandard/Article/detail/811688?ref=25 Metrics - USING QUALITY BY DESIGN TO IMPROVE STRENGTH, FRIABILITY 2013-04-26T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172013/811688null HTML http://www.pharmtech.com/pharmtech/News/Catalent-Biologics-Opens-New-Single-Use-Biomanufac/ArticleStandard/Article/detail/811649?ref=25 Catalent Pharma Solutions, a provider of drug and biologic development services, delivery technologies and supply solutions, has officially opened a new biomanufacturing center of excellence in Madison. The facility, which was constructed in response to customer demand, is expected to quadruple Catalent's current biologics manufacturing capacity and extensively utilise single-use technology for greater flexibility and efficiency. It will allow the company to extend its offerings in the biologics sector while enhancing the efficiency and output of its proprietary GPEx cell line engineering technology as well as other mammalian cell lines. 2013-04-26T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172013/811649null HTML http://www.pharmtech.com/pharmtech/News/Pharmaceutical-Technology-and-DampB-Launch-Busines/ArticleStandard/Article/detail/811687?ref=25 Pharmaceutical Technology has joined with Dun & Bradstreet Credibility Corp. to launch the Pharmaceutical Technology and BioPharm International Marketplace. 2013-04-26T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172013/811687null HTML http://www.pharmtech.com/pharmtech/Analytics/Is-My-Method-Still-Valid/ArticleStandard/Article/detail/811595?ref=25 This paper outlines the importance of method validation including the official requirements, characteristics to be validated and minimum requirements, helping to ensure that the data generated are reliable. 2013-04-25T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172013/811595null REMOTE http://www.pharmtech.com/pharmtech/Manufacturing+Whitepaper/Impact-of-a-Customized-MALDI-TOF-Library-for-Micro/ArticleStandard/Article/detail/811596?ref=25 This study assesses the suitability of the Biotyper platform for identifying environmental isolates, demonstrates our systematic approach to broaden the reference library and shows the impact of adding new library entries on reportability for this industrial sector. 2013-04-25T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172013/811596null REMOTE http://www.pharmtech.com/pharmtech/Standards+%26+Regulation/Establishing-a-Culture-of-Quality/ArticleStandard/Article/detail/811594?ref=25 For companies seeking to prevent or remediate regulatory compliance violations, establishing a culture of quality is of the essence. In industries strongly affected by regulatory compliance, product quality is inextricably linked to a company?s well-being. Learn more about cultivating and nourishing a culture of quality in your firm. 2013-04-25T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172013/811594null REMOTE http://www.pharmtech.com/pharmtech/Biological-Storage-Facility/ArticleStandard/Article/detail/811196?ref=25 Vindon?s UK storage suite based in Rochdale offers 2000 cubic meters of controlled environment storage space. 2013-04-25T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172013/811196null HTML http://www.pharmtech.com/pharmtech/Waters-Purification-Solutions/ArticleStandard/Article/detail/811198?ref=25 Waters' robust purification solutions are flexible, scalable, and easily integrated. 2013-04-25T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172013/811198null HTML http://www.pharmtech.com/pharmtech/Vetter-Development-Service-Filling-your-clinical-d/ArticleStandard/Article/detail/811190?ref=25 Vetter Development Service (VDS) provides expert support for your drug-development projects, from inception to market launch 2013-04-25T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172013/811190null HTML http://www.pharmtech.com/pharmtech/The-Daikyo-Crystal-Zenith-Insert-Needle-Syringe-Sy/ArticleStandard/Article/detail/811197?ref=25 Protect your drug product?s integrity with the industry?s first adhesive- and tungsten-free insert needle syringe system, the Daikyo Crystal Zenith Insert Needle Syringe System. 2013-04-25T04:00:00Z http://www.pharmtech.com/pharmtech/data/articlestandard/pharmtech/172013/811197null HTML