http://www.biopharminternational.com/biopharm Peer-reviewed technical articles, multimedia, and news on bioprocessing methods, regulatory compliance, and business strategies related to the development and manufacture of biotechnology-based drugs. 2012-02-22T23:40:47Z http://www.biopharminternational.com/biopharm/News/South-Africa-Plans-Joint-Venture-for-New-API-Plant/ArticleStandard/Article/detail/759060?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 (ARV) medicines. 2012-02-21T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/072012/759060null HTML http://www.biopharminternational.com/biopharm/News/White-Housersquos-2013-Budget-Includes-FDA-Increas/ArticleStandard/Article/detail/759058?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 2012-02-21T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/072012/759058null HTML http://www.biopharminternational.com/biopharm/News/FDA-Releases-Draft-Guidance-on-Monitoring-Crude-He/ArticleStandard/Article/detail/759059?ref=25 FDA has released a draft guidance for API manufacturers titled Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality. 2012-02-21T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/072012/759059null HTML http://www.biopharminternational.com/biopharm/News/GlaxoSmithKline-Tracks-RampD-Performance/ArticleStandard/Article/detail/758575?ref=25 GlaxoSmithKline (GSK) released its fourth quarter and full year 2011 earnings report on Feb. 7, 2012. In the report, the company tracks its R&D performance, and calculated the return on R&D to be 12%, up from 11% in 2010, and closing in on the company’s goal of a 14% return. 2012-02-14T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/072012/758575null HTML http://www.biopharminternational.com/biopharm/News/EMA-to-Implement-Pharmacovigilance/ArticleStandard/Article/detail/758574?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. 2012-02-14T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/072012/758574null HTML http://www.biopharminternational.com/biopharm/News/FDA-Unveils-Guidance-for-Biosimilar-Development/ArticleStandard/Article/detail/758572?ref=25 After months of anticipation, FDA issued guidances last month that outlines its recommendations for developing and approving biosimilar therapies. 2012-02-14T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/072012/758572null HTML http://www.biopharminternational.com/biopharm/News/FDA-Commissioner-Testifies-for-PDUFA-Reauthorizati/ArticleStandard/Article/detail/758573?ref=25 On Feb. 1, 2012, 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 (PDUFA), also known as PDUFA V. She also outlined a series of recommendations, sent to Congress in January 2012, to include in PDUFA V. 2012-02-14T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/072012/758573null HTML http://www.biopharminternational.com/biopharm/Drawing-External-Inspiration-for-Project-Managemen/ArticleStandard/Article/detail/758182?ref=25 In today's high-cost, highly competitive drug development environment, where complex compounds require sophisticated technology and great expertise, small biotech companies find themselves particularly vulnerable to risk during the early clinical phases. A strategy planned in concert with a contract development and manufacturing organization (CDMO) is often the key to properly allocating resources, creating a top-notch project management team, satisfying regulatory authorities, and advancing the compound to later-phase development. 2012-02-13T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/062012/758182null HTML http://www.biopharminternational.com/biopharm/Podcast-Key-Value-Considerations-for-Growing-BioPh/ArticleStandard/Article/detail/758415?ref=25 BioPharm International interviews Tarja Mottram, CEO of Action for Results, about a paradigm shift in how we measure and provide evidence for the impact of a product on healthcare outcomes. Posted Feb. 2012. 2012-02-10T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/062012/758415null HTML http://www.biopharminternational.com/biopharm/Podcast-Key-Business-Considerations-for-Growing-Bi/ArticleStandard/Article/detail/758414?ref=25 BioPharm International interviews Tarja Mottram, CEO of Action for Results, on the marriage of science and business to ensure sustainable growth. Posted Feb. 2012. 2012-02-10T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/062012/758414null HTML http://www.biopharminternational.com/biopharm/Nice-Insights-Business-Data-Quarter-4-2011/ArticleStandard/Article/detail/758057?ref=25 2012-02-07T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/062012/758057null PDF http://www.biopharminternational.com/biopharm/Unique-Considerations-When-Working-with-Suppliers/ArticleStandard/Article/detail/757720?ref=25 When a pharmaceutical supply chain is compromised, there can be disastrous consequences, not only for consumers, but also for manufacturers. Without comprehensive security measures, pharmaceuticals are susceptible to counterfeit, diversion, dilution, tampering and deliberate contamination ultimately compromising patient safety. 2012-02-03T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/052012/757720null HTML http://www.biopharminternational.com/biopharm/News/Pharma-Targets-Tropical-Diseases/ArticleStandard/Article/detail/757751?ref=25 Pfizer, Sanofi, GlaxoSmithKline, and other major pharmaceutical companies have joined forces and pledged to defeat 10 neglected tropical diseases (NTDs) 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 (WHO), and several other global health entities. 2012-02-03T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/052012/757751null HTML http://www.biopharminternational.com/biopharm/News/PhRMA-Transitions-Management-of-its-Benefit-Risk-A/ArticleStandard/Article/detail/757756?ref=25 The Pharmaceutical Research and Manufacturers of America (PhRMA) announced that it will transition the management of its benefit?risk action team (BRAT) to the Centre for Innovation in Regulatory Science (CIRS), according to a press release. CIRS is a neutral, independent UK-based subsidiary company, forming part of the Intellectual Property and Science business of Thomson Reuters. This transition is being made to further the program?s technical development and broaden input from the scientific community. 2012-02-03T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/052012/757756null HTML http://www.biopharminternational.com/biopharm/News/FDA-Files-Consent-Decree-Against-Ranbaxy/ArticleStandard/Article/detail/757753?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 consent decree was filed against Ranbaxy Laboratories Ltd., an Indian corporation, and its subsidiary Ranbaxy Inc., headquartered in Princeton, New Jersey. The decree was filed on Jan. 25, 2012, and is subject to court approval. 2012-02-03T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/052012/757753null HTML http://www.biopharminternational.com/biopharm/News/Pfizers-2011-Financial-Information-Shows-Overall-I/ArticleStandard/Article/detail/757754?ref=25 Pfizer announced a decrease in fourth-quarter revenues, but a slight increase in full-year 2011 revenues in its financial report issued on Jan. 31, 2012. Ian Read, chairman and CEO, stated in a company release, ?Overall, 2011 was a year of setting new direction and focus for Pfizer. I am pleased with our 2011 financial performance, which was achieved in the face of a challenging global market and product losses of exclusivity of approximately $5 billion.? 2012-02-03T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/052012/757754null HTML http://www.biopharminternational.com/biopharm/Outsourcing/What-the-2011-Census-of-India-Reveals-for-Pharma/ArticleStandard/Article/detail/757929?ref=25 The census reveals the state of the population of India's health and the potential for growth in the healthcare market. 2012-02-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/062012/757929/BP0212_28_sb10065413a-001_flash.jpg XML http://www.biopharminternational.com/biopharm/Outsourcing/Preparing-For-the-New-China/ArticleStandard/Article/detail/757939?ref=25 China's healthcare reforms generate uncertainty for its domestic pharmaceutical market. 2012-02-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/062012/757939/BP0212_26_93522323_flash.jpg XML http://www.biopharminternational.com/biopharm/Outsourcing/The-Challenges-of-Emerging-Markets/ArticleStandard/Article/detail/757932?ref=25 The difficulties of doing business in China are offset by its adoption of more stringent GMP standards. 2012-02-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/062012/757932null XML http://www.biopharminternational.com/biopharm/Quality/Saving-the-Next-Generation-of-Regulatory-Scientist/ArticleStandard/Article/detail/757933?ref=25 New educational programs are key to the industry's future and to safe, available drugs. 2012-02-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/062012/757933null XML http://www.biopharminternational.com/biopharm/Quality/FDA-and-Justice-Department-Address-Drug-Quality-Co/ArticleStandard/Article/detail/757934?ref=25 More collaboration and expanded oversight aim to compel manufacturers to follow GMPs. 2012-02-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/062012/757934null XML http://www.biopharminternational.com/biopharm/Outsourcing/Biomanufacturing-Outsourcing-Outlook/ArticleStandard/Article/detail/757935?ref=25 Industry optimism is on the rise for 2012. 2012-02-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/062012/757935null XML http://www.biopharminternational.com/biopharm/Quality/The-Drive-for-Best-Practice-in-Biopharmaceutical-M/ArticleStandard/Article/detail/757931?ref=25 Introducing a new way to think about sharing information in a patent-driven industry. 2012-02-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/062012/757931null XML http://www.biopharminternational.com/biopharm/Upstream+Processing/A-25-Year-Retrospective-on-Mammalian-Cell-Culture/ArticleStandard/Article/detail/757941?ref=25 This month, we revisit "Industrial-Scale Mammalian Cell Culture, Part I: Bioreactor Design Considerations." 2012-02-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/062012/757941null XML http://www.biopharminternational.com/biopharm/Disposables+Advisor/Understanding-Gamma-Sterilization/ArticleStandard/Article/detail/757930?ref=25 This article outlines methods, validation standards, and documentation of sterilization of single-use products using gamma irradiation. 2012-02-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/062012/757930null XML http://www.biopharminternational.com/biopharm/Whitepapers/Biosimilar-Development-From-Science-to-Market/ArticleStandard/Article/detail/757374?ref=25 Various countries have established pathways to allow “copies” of an off-patent biotherapeutic product on the market. This paper addresses the regulatory hurdles and characterization challenges of developing a Biosimilar product. 2012-02-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/052012/757374null REMOTE http://www.biopharminternational.com/biopharm/Quality/Sustainable-Investment/ArticleStandard/Article/detail/757937?ref=25 Industry announces plans for year ahead at annual JPMorgan Global Healthcare Conference. 2012-02-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/062012/757937null XML http://www.biopharminternational.com/biopharm/GMPs%2FValidation/Assessing-the-Risk-of-Leachables-from-Single-Use-S/ArticleStandard/Article/detail/757938?ref=25 This article is the second in a two-part series on extractables and leachables. 2012-02-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/062012/757938/BP0212_35_Figure2_flash.jpg XML http://www.biopharminternational.com/biopharm/Outsourcing/Trends-and-Challenges-in-Biologics-Outsourcing-A-Q/ArticleStandard/Article/detail/757940?ref=25 Stephen Taylor PhD, vice-president and commercial director at Fujifilm Diosynth Biotechnologies, addresses some of the challenges facing biologics outsourcing. 2012-02-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/062012/757940null XML http://www.biopharminternational.com/biopharm/GMPs%2FValidation/A-Risk-Based-Approach-to-Transferring-a-Mature-Bio/ArticleStandard/Article/detail/757936?ref=25 Strategies for transfer of the manufacturing process. 2012-02-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/062012/757936/BP0212_46_Fig5_flash.jpg XML http://www.biopharminternational.com/biopharm/Quality/PQRI-Case-Study-Facility-Biocontainment-and-Inacti/ArticleStandard/Article/detail/757942?ref=25 A Risk-Management Case Study. 2012-02-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/062012/757942null XML http://www.biopharminternational.com/biopharm/SGS---Biosimilar-Development-From-Science-to-Marke/ArticleStandard/Article/detail/757373?ref=25 SGS - Biosimilar Development: From Science to Market 2012-01-31T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/052012/757373null HTML http://www.biopharminternational.com/biopharm/Whitepapers/High-Resolution-Fast-MAb-Charge-Variant-Analysis/ArticleStandard/Article/detail/757349?ref=25 These new Thermo Scientific MAbPac SCX small particle phase columns were developed for high resolution separations wand orthogonal selectivity for MAb charge variant characterization. Separations using these columns on the bio-inert Thermo Scientific Dionex UltiMate 3000 Titanium LC System revealed high-resolution, fast analysis of MAb variants. 2012-01-31T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/052012/757349null REMOTE http://www.biopharminternational.com/biopharm/Downstream+Processing/Quality-By-Design-in-Biomanufacturing-Bioproductio/ArticleStandard/Article/detail/745826?ref=25 QbD is increasingly required in our industry, but there are still gaps in understanding how QbD applies to the biomanufacturing process. This whitepaper looks at how biomanufacturing organizations can achieve continuous quality verification. We focus on simple, practical examples of how top-tier biomanufacturers have implemented QbD. 2012-01-31T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/442011/745826null REMOTE http://www.biopharminternational.com/biopharm/Key-Considerations-for-Commercializing-a-Compound/ArticleStandard/Article/detail/757254?ref=25 In this BioPharm International interview, Joerg Zimmerman, director of process development and implementation at Vetter, discusses key considerations for commercializing a compound under development. The podcast includes case study examples, technical challenges faced during drug development, and sound advice to facilitate the process. Regulatory expectations for biological formulations in prefilled syringes as combination products and the need to establish compatibility at an early stage in development are also discussed. 2012-01-30T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/052012/757254null HTML http://www.biopharminternational.com/biopharm/Retrospective-Original-Mammalian-Cell-Culture-1988/ArticleStandard/Article/detail/757229?ref=25 2012-01-27T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/042012/757229null PDF http://www.biopharminternational.com/biopharm/News/Global-Market-Boom-for-Generic-Drugs/ArticleStandard/Article/detail/756830?ref=25 The generic-drugs market is poised to experience strong growth as key blockbuster products go off patent, but companies looking to benefit from this will have to be careful about the product segments where they compete, according to a report from Frost & Sullivan. 2012-01-24T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/042012/756830null HTML http://www.biopharminternational.com/biopharm/News/FDA-Recommends-Three-Drug-User-Fee-Programs/ArticleStandard/Article/detail/756828?ref=25 On Jan. 13, 2012, FDA announced it had completed, and transmitted to Congress, its recommendations for three user fee programs including the fifth authorization of the Prescription Drug User Fee Act (PDUFA) and programs for human generic drugs and biosimilar biological products. 2012-01-24T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/042012/756828null HTML http://www.biopharminternational.com/biopharm/News/AstraZeneca-and-IMS-Health-Announce-Data-and-Resea/ArticleStandard/Article/detail/756829?ref=25 On Jan. 11, 2012, AstraZeneca and IMS Health announced a three-year collaboration to use real-world healthcare data from Europe to guide AstraZeneca?s discovery and clinical development programs. 2012-01-24T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/042012/756829null HTML http://www.biopharminternational.com/biopharm/BioPharm-International-Celebrates-25-Years/ArticleStandard/Article/detail/756831?ref=25 Throughout BioPharm International's 25th Anniversary Year, 2012, we will be rewinding to articles published in the journal's first volume to see where and how technologies have changed in the past couple of decades as well as what the industry may look forward to. 2012-01-23T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/042012/756831null HTML http://www.biopharminternational.com/biopharm/Thermo---High-Resolution-Fast-MAb-Charge-Variant-A/ArticleStandard/Article/detail/756568?ref=25 Thermo - High-Resolution, Fast MAb Charge Variant Analysis 2012-01-18T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/032012/756568null HTML http://www.biopharminternational.com/biopharm/Thermo---High-Resolution-Fast-MAb-Charge-Variant-A/ArticleStandard/Article/detail/756570?ref=25 Thermo - High-Resolution, Fast MAb Charge Variant Analysis 2012-01-18T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/032012/756570null HTML http://www.biopharminternational.com/biopharm/News/USP-Announces-Proposed-Standard-for-Supply-Chain-I/ArticleStandard/Article/detail/756300?ref=25 The US Pharmacopeia (USP) announced in a press release a draft standard contained in the proposed USP General Chapter <1083> Good Distribution Practices?Supply Chain Integrity. 2012-01-17T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/022012/756300null HTML http://www.biopharminternational.com/biopharm/News/BMS-to-Acquire-Inhibitex-for-25-Billion/ArticleStandard/Article/detail/756298?ref=25 Bristol-Myers Squibb (BMS) has signed an agreement to acquire the clinical-stage biotechnology company Inhibitex in a deal worth approximately $2.5 billion. 2012-01-17T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/022012/756298null HTML http://www.biopharminternational.com/biopharm/News/Novartis-Issues-Recall-and-Suspends-Operations-at-/ArticleStandard/Article/detail/756301?ref=25 Novartis Consumer Health has announced a voluntary recall of all lots of select, bottle-packaged configurations of Excedrin, NoDoz, Bufferin and Gas-X Prevention. 2012-01-17T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/022012/756301null HTML http://www.biopharminternational.com/biopharm/Podcasts/Podcast-2012-Retrospective-on-Separations-Technolo/ArticleStandard/Article/detail/755182?ref=25 Mike Ultee, chief scientific officer of Laureate Biopharmaceutical Services, discusses advances in separations technology, beginning with the 1988 publication of ?Separations Technology Outlook, Part II? by Nancy E. Pfund and Kathleen G. Charles. 2012-01-16T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/012012/755182null HTML http://www.biopharminternational.com/biopharm/News/FDA-Draft-Guidance-Offers-Social-Media-Insight/ArticleStandard/Article/detail/755178?ref=25 FDA has released a new draft guidance that offers recommendations to companies wishing to respond to unsolicited requests for off-label information, including requests made via social media websites. 2012-01-10T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/012012/755178null HTML http://www.biopharminternational.com/biopharm/News/Ben-Venue-Continues-Suspension-of-Manufacturing-Ac/ArticleStandard/Article/detail/755180?ref=25 Ben Venue Laboratories is extending its voluntary suspension of manufacturing at its Bedford, Ohio, facility. The company had originally announced the suspension on Nov. 19, 2011, and announced the extension of the suspension on Dec. 23, 2011. 2012-01-10T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/012012/755180null HTML http://www.biopharminternational.com/biopharm/News/FDA-Creates-Shared-REMS-System-for-TIRF-Medicines/ArticleStandard/Article/detail/755181?ref=25 On Dec. 29, 2011, FDA approved the TIRF REMS Access Program, a single-shared risk evaluation and mitigation strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) products, narcotic pain medicines used by cancer patients to manage pain. 2012-01-10T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/012012/755181null HTML http://www.biopharminternational.com/biopharm/News/NIH-Establishes-National-Center-for-Advancing-Tran/ArticleStandard/Article/detail/755179?ref=25 The National Institutes of Health (NIH) announced in a press release the establishment of the National Center for Advancing Translational Sciences (NCATS), a center dedicated to the translation of scientific discoveries into new drugs, diagnostics, and devices. 2012-01-10T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/012012/755179null HTML http://www.biopharminternational.com/biopharm/News/Baxter-and-Momenta-to-Develop-Follow-On-Biologics/ArticleStandard/Article/detail/754237?ref=25 On Dec. 22, 2011, Baxter International and Momenta Pharmaceuticals entered into a global collaboration to develop and commercialize follow-on biologic products. Baxter will contribute its clinical-development and biologic-manufacturing expertise, experience with sterile injectables, and global commercial capabilities to the collaboration. Momenta will bring its expertise in high-resolution analytics, characterization, and product and process development to the joint effort. 2012-01-03T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/532011/754237null HTML http://www.biopharminternational.com/biopharm/News/Pfizer-GSK-Commit-to-Supplying-Developing-World-wi/ArticleStandard/Article/detail/754235?ref=25 Pfizer and GlaxoSmithKline (GSK) entered into separate agreements with the GAVI Alliance to supply pneumococcal vaccines to developing countries. Pneumococcal disease can lead to pneumonia, meningitis, and sepsis and is one of the leading causes of death in children under the age of five in developing countries. 2012-01-03T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/532011/754235null HTML http://www.biopharminternational.com/biopharm/News/Ranbaxy-Signs-Consent-Decree-with-FDA/ArticleStandard/Article/detail/754236?ref=25 On Dec. 21, 2011, Ranbaxy Laboratories signed a consent decree with FDA and pledged that it would strengthen procedures and policies to ensure data integrity and to comply with current good manufacturing practices. The agreement is subject to approval by the US District Court for the District of Maryland. 2012-01-03T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/532011/754236null HTML http://www.biopharminternational.com/biopharm/2012-Anniversary-Retrospectives/ArticleStandard/Article/detail/757360?ref=25 Each month, BioPharm International reviews articles from the journal's first volume and speaks with original authors and experts about what's changed in various technical fields of the biopharma industry during the past 25 years. 2012-01-02T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/052012/757360null HTML http://www.biopharminternational.com/biopharm/Quality/Budget-Crunch-Political-Battles-Shape-Policy-Agend/ArticleStandard/Article/detail/754431?ref=25 Pressure to approve new user fees opens the door to action on drug shortages, prices, and regulation. 2012-01-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/532011/754431null XML http://www.biopharminternational.com/biopharm/Perspectives+on+Outsourcing/Contract-Services-in-2012/ArticleStandard/Article/detail/754436?ref=25 Some recent private-equity buyouts of CROs show both the upside and downside for investors. 2012-01-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/532011/754436null XML http://www.biopharminternational.com/biopharm/Downstream+Processing/An-Overview-of-Risk-Assessment-Strategies-for-Extr/ArticleStandard/Article/detail/754432?ref=25 Approaches for risk assessment of extractables and leachables. 2012-01-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/532011/754432/BP0112_41_Tutorial-Stone_Figure-1_web_flash.jpg XML http://www.biopharminternational.com/biopharm/Quality/Heres-to-a-Year-of-Compromise/ArticleStandard/Article/detail/754433?ref=25 The benefits of harmonization may be on industry's wish list, but buying into change is another story. 2012-01-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/532011/754433null XML http://www.biopharminternational.com/biopharm/Upstream+Processing/The-Conception-and-Production-of-Conjugate-Vaccine/ArticleStandard/Article/detail/754435?ref=25 Recombinant technology can be used to produce conjugate vaccines. 2012-01-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/532011/754435/BP0112_25_95468876_web_flash.jpg XML http://www.biopharminternational.com/biopharm/Quality/A-25-Year-Retrospective-on-Separations-Technology/ArticleStandard/Article/detail/754428?ref=25 This month, we rewind to "Separations Technology Outlook, Part II: Improved Recovery and Greater Purity." 2012-01-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/532011/754428null XML http://www.biopharminternational.com/biopharm/Final+Word/USAID-Moves-Global-Healthcare-Initiatives-Forward/ArticleStandard/Article/detail/754434?ref=25 Government plans require investment, partnership, and industry collaboration. 2012-01-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/532011/754434null XML http://www.biopharminternational.com/biopharm/GMPs%2FValidation/Global-Economic-Woes-Overshadow-Biotech-Industry-A/ArticleStandard/Article/detail/754427?ref=25 Greater emphasis on focus and efficiency for companies as market demands value in 2012. 2012-01-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/532011/754427null XML http://www.biopharminternational.com/biopharm/Downstream+Processing/Therapeutic-Vaccine-Outlook/ArticleStandard/Article/detail/754816?ref=25 Has an approval in oncology reignited interest in the recruitment of the immune system in the fight against disease? 2012-01-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/012012/754816/BP0112_25_95468876_web_flash.jpg XML http://www.biopharminternational.com/biopharm/Retrospective-Original-Separations-Technology-1988/ArticleStandard/Article/detail/757361?ref=25 2012-01-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/052012/757361null PDF http://www.biopharminternational.com/biopharm/GMPs%2FValidation/Auditing-by-the-Numbers/ArticleStandard/Article/detail/754429?ref=25 Contract organizations must have highly organized teams and plans to accommodate today's audits. 2012-01-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/532011/754429null XML http://www.biopharminternational.com/biopharm/Downstream+Processing/Ice-Fog-as-a-Means-to-Induce-Uniform-Ice-Nucleatio/ArticleStandard/Article/detail/754430?ref=25 The authors describe a novel means to control ice nucleation using a sterile cryogenic ice fog. 2012-01-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/532011/754430/PeerReviewbutton_main.jpg http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/532011/754430/BP0112_37_Chakravartya-Figure-5_web_flash.jpg XML http://www.biopharminternational.com/biopharm/Whitepapers/Mass-Spectrometry-Compatible-Separation-of-Itracon/ArticleStandard/Article/detail/754113?ref=25 The application replicates the Chinese Pharmacopeia related substances method and shows a faster and MS-compatible UHPLC method for the separation of Itraconazole and its impurities. 2011-12-27T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/532011/754113null REMOTE http://www.biopharminternational.com/biopharm/News/FDA-Warns-Novartis-of-Violations-at-Three-Plants/ArticleStandard/Article/detail/753355?ref=25 In a Warning Letter, FDA cited ?significant violations? of CGMP regulations, including several repeat observations, at three Novartis facilities. The violations included failure to prevent microbiological contamination of sterile drug products, failure to investigate out-of-specification batches, failure to clean and maintain equipment, and failure to ensure drugs? identity, strength, quality, and purity. 2011-12-20T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/522011/753355null HTML http://www.biopharminternational.com/biopharm/News/AstraZeneca-to-Expand-Presence-in-China/ArticleStandard/Article/detail/753353?ref=25 AstraZeneca entered into an agreement to acquire Guangdong BeiKang Pharmaceutical, a privately owned generic-drug manufacturing company based in Guangdong province, China, for an undisclosed amount. Guangdong BeiKang Pharmaceutical?s portfolio includes injectable medicines used to treat infections. Upon completion of the acquisition, AstraZeneca will be responsible for the manufacture and commercialization of these medicines. The deal is contingent upon approval from the Ministry of Commerce in China and is expected to close in the first quarter of 2012. 2011-12-20T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/522011/753353null HTML http://www.biopharminternational.com/biopharm/News/FDA-EMA-Joint-Manufacturing-Inspections-to-Begin-i/ArticleStandard/Article/detail/753350?ref=25 The FDA and EMA are moving from "confidence-building to reliance upon" each other in a step-up in cooperation on GMP inspections; the latest move following successful completion of pilot projects this summer. The initiative will begin in January 2012, according to a jointly issued press release on Dec. 9, 2011, and will enable the two authorities to rely on each other's inspections outcomes instead of conducting inspections in duplicate 2011-12-20T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/522011/753350null HTML http://www.biopharminternational.com/biopharm/News/EMA-Addresses-Ben-Venue-Quality-Issues/ArticleStandard/Article/detail/753356?ref=25 After reviewing the ?shortcomings in quality assurance? that were recently identified at Ben Venue Laboratories?s Bedford, Ohio, facility, EMA issued several recommendations, including product recalls for Ecalta, Liminity and Vistide. EMA?s Committee for Medicinal Products for Human Use has been reviewing medicines manufactured at Ben Venue since early November 2011, after a joint GMP inspection by FDA and the UK and French medicines regulatory agencies highlighted several problems in the company?s quality-management system, particularly in relation to the sterile filling process and possible particle contamination during manufacturing. 2011-12-20T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/522011/753356null HTML http://www.biopharminternational.com/biopharm/Playing-the-Drug-Development-Game/ArticleStandard/Article/detail/753351?ref=25 Biotechnology projects are complex and subject to many levels of risk during the early clinical phases. What are the secrets to winning at the drug development game? 2011-12-19T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/522011/753351null HTML http://www.biopharminternational.com/biopharm/News/AstraZeneca-and-MRC-form-Landmark-Collaboration/ArticleStandard/Article/detail/752321?ref=25 In an initiative that could signal a new era in private?public partnerships, AstraZeneca will make 22 compounds available for free to medical researchers next year for projects funded by the United Kingdom?s (UK) Medical Research Council (MRC). 2011-12-13T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/512011/752321null HTML http://www.biopharminternational.com/biopharm/News/PhRMA-Foundation-Funds-Comparative-Effectiveness-R/ArticleStandard/Article/detail/752322?ref=25 On Dec. 1, 2011, the Pharmaceutical Research and Manufacturers of America (PhRMA) Foundation awarded Johns Hopkins University and the University of Washington each a $250,000 grant to establish a three-year graduate certificate program. 2011-12-13T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/512011/752322null HTML http://www.biopharminternational.com/biopharm/News/Biogen-Idec-Samsung-Form-Biosimilars-Joint-Venture/ArticleStandard/Article/detail/752315?ref=25 Samsung and Biogen Idec agreed to invest $300 million to establish a joint venture to develop, manufacture, and market biosimilars. The deal is Samsung?s latest effort to strengthen its position in biosimilars. 2011-12-13T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/512011/752315null HTML http://www.biopharminternational.com/biopharm/News/FDA-Announces-Public-Meeting-to-Discuss-Biosimilar/ArticleStandard/Article/detail/752318?ref=25 On Dec. 6, 2011, FDA announced that a public meeting will be held on Dec. 16, 2011 to discuss recommendations for a user-fee program for biosimilar biological products for fiscal years 2013?2017. 2011-12-13T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/512011/752318null HTML http://www.biopharminternational.com/biopharm/News/UK-Adopts-Multimillion-Pound-Life-Sciences-Strateg/ArticleStandard/Article/detail/752320?ref=25 The United Kingdom?s (UK) life-sciences industry this week welcomed a new, multimillion-pound strategy that aims to both support the industry and encourage innovation in the unsettled economic climate. 2011-12-13T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/512011/752320null HTML http://www.biopharminternational.com/biopharm/News/Gilead-Acquires-Pharmasset-for-11-Billion/ArticleStandard/Article/detail/751462?ref=25 On Nov. 21, 2011, Gilead Sciences agreed to acquire Pharmasset for $137 per share in cash, or a total of approximately $11 billion. Pharmasset’s board of directors unanimously approved the transaction, which is expected to close during the first quarter of 2012. Gilead will finance the transaction with cash, bank debt, and senior unsecured notes. 2011-12-06T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/502011/751462null HTML http://www.biopharminternational.com/biopharm/News/Elan-University-of-Cambridge-Launch-New-Research-C/ArticleStandard/Article/detail/751460?ref=25 Elan and the University of Cambridge have launched a center for innovation and drug discovery that will focus on translational research into therapies for Alzheimer?s and Parkinson?s diseases. The Cambridge?Elan Center will be located at the University of Cambridge, and the agreement between the two will last for 10 years. Its goal is to discover novel compounds that can alter the behavior of proteins associated with neurodegenerative disorders and be developed into new treatments. 2011-12-06T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/502011/751460null HTML http://www.biopharminternational.com/biopharm/News/Merck-Resolves-Claims-Related-to-Vioxx-for-950-Mil/ArticleStandard/Article/detail/751461?ref=25 The justice department announced that the US pharmaceutical company Merck & Co. has agreed to pay $950 million to resolve criminal charges and civil claims related to its promotion and marketing of the painkiller Vioxx. 2011-12-06T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/502011/751461null HTML http://www.biopharminternational.com/biopharm/Podcasts/Podcast-Sutro-Biopharmas-Trevor-Hallam-offers-a-gl/ArticleStandard/Article/detail/751526?ref=25 BioPharm International interviews Trevor Hallam, chief scientific officer at Sutro Biopharma. Posted Dec. 2011. 2011-12-05T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/502011/751526null HTML http://www.biopharminternational.com/biopharm/Podcasts/Podcast-Strong-Product-Differentiation/ArticleStandard/Article/detail/753765?ref=25 BioPharm International interviews Anjan Selz, CEO of Finox Biotech, about meeting regulatory expectations in biosimilar development. Posted Jan. 2012. 2011-12-05T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/522011/753765null HTML http://www.biopharminternational.com/biopharm/Podcasts/Podcast-Biosimilar-Development/ArticleStandard/Article/detail/753761?ref=25 BioPharm International interviews Anjan Selz, CEO of Finox Biotech, about biosimilar development. Posted Dec. 2011. 2011-12-05T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/522011/753761null HTML http://www.biopharminternational.com/biopharm/Podcasts/Podcast-Meeting-Regulatory-Expectations/ArticleStandard/Article/detail/753762?ref=25 BioPharm International interviews Anjan Selz, CEO of Finox Biotech, about meeting regulatory expectations in biosimilar development. Posted Jan. 2012. 2011-12-05T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/522011/753762null HTML http://www.biopharminternational.com/biopharm/Biosimilar-Development-in-a-Virtual-Biotech-Enviro/ArticleStandard/Article/detail/756691?ref=25 Virtual biotech CEO Anjan Selz focuses on product development, credibility and differentiation. 2011-12-05T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/032012/756691null HTML http://www.biopharminternational.com/biopharm/Biosimilar-development-in-a-virtual-biotech-set-up/ArticleStandard/Article/detail/756496?ref=25 How does working in a virtual biotech environment affect biosimilar development? Anjan Selz outlines target and partner selection in this first of a two part article. 2011-12-05T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/032012/756496null HTML http://www.biopharminternational.com/biopharm/Rentschler-Biotechnologie/ArticleStandard/Article/detail/749949?ref=25 Rentschler Biotechnologie Corporate Capabilities 2011. 2011-12-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/482011/749949null PDF http://www.biopharminternational.com/biopharm/Sartorius-Stedim-North-America-Inc/ArticleStandard/Article/detail/749950?ref=25 Sartorius Stedim North America, Inc. corporate capabilities 2011. 2011-12-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/482011/749950null PDF http://www.biopharminternational.com/biopharm/Quality/Supporting-Innovation-Requires-Consistency-and-Vis/ArticleStandard/Article/detail/750857?ref=25 Political leaders need to consider the impact of the biopharmaceutical industry on the economy. 2011-12-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/492011/750857null XML http://www.biopharminternational.com/biopharm/Quality/FDA-Revamps-to-Meet-New-Challenges/ArticleStandard/Article/detail/750862?ref=25 Added responsibilities and outside concerns prompt overhaul of agency's structure. 2011-12-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/492011/750862null XML http://www.biopharminternational.com/biopharm/GMPs%2FValidation/The-Employment-Outlook-Brightens/ArticleStandard/Article/detail/750859?ref=25 Readers react to the economic turmoil of the past year and look longingly forward to 2012. 2011-12-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/492011/750859/BP1211_22_103772148_web_flash.jpg XML http://www.biopharminternational.com/biopharm/SGS-Life-Science-Services/ArticleStandard/Article/detail/749951?ref=25 SFS Life Science Services Corporate Capabilities 2011. 2011-12-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/482011/749951null PDF http://www.biopharminternational.com/biopharm/Outsourcing/Troublesome-Signs-for-BioPharmaceutical-RampD/ArticleStandard/Article/detail/750856?ref=25 A dearth of late-stage candidates could hurt the pharmaceutical services market in the future. 2011-12-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/492011/750856null XML http://www.biopharminternational.com/biopharm/Vetter/ArticleStandard/Article/detail/749952?ref=25 Vetter Corporate Capabilities 2011. 2011-12-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/482011/749952null PDF http://www.biopharminternational.com/biopharm/Final+Word/The-Case-for-Pediatric-Exclusivity/ArticleStandard/Article/detail/750858?ref=25 Reauthorization of pediatric exclusivity provisions looms in 2012 and debates begin anew. 2011-12-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/492011/750858null XML http://www.biopharminternational.com/biopharm/Downstream+Processing/Efficient-Prion-Removal-from-Gonadotropin-Solution/ArticleStandard/Article/detail/750861?ref=25 Can a nanofiltration process be leveraged for removal of prions? 2011-12-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/492011/750861/BP1211_37_Prion_Figure1_web_flash.jpg XML http://www.biopharminternational.com/biopharm/Disposables/Methods-for-the-Automated-Manufacturing-of-an-Auto/ArticleStandard/Article/detail/750860?ref=25 The author describes automated equipment that uses functionally closed disposables. 2011-12-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/492011/750860/BP1211_54_DendriticCellFig4_web_flash.jpg XML http://www.biopharminternational.com/biopharm/GE-healthcare/ArticleStandard/Article/detail/749947?ref=25 GE Healthcare Corporate Capabilities 2011. 2011-12-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/482011/749947null PDF http://www.biopharminternational.com/biopharm/Lancaster-Laboratories/ArticleStandard/Article/detail/749948?ref=25 Lancaster Laboratories 2011-12-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/482011/749948null PDF http://www.biopharminternational.com/biopharm/Corporate-Capabilities-2011/ArticleStandard/Article/detail/749946?ref=25 Corporate Capabilities profiles were included in the December issue of BioPharm 2011. 2011-12-01T05:00:00Z http://www.biopharminternational.com/biopharm/data/articlestandard/biopharm/482011/749946null HTML