http://biopharminternational.findpharma.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. 2008-12-01T23:12:28Z http://biopharminternational.findpharma.com/biopharm/Millipore-and-Applikon-Collaborate-on-Disposable-B/ArticleStandard/Article/detail/566144?ref=25 Millipore Corporation (Billerica, MA) and Applikon Biotechnology BV (Schiedam, The Netherlands) have announced an agreement to co-develop and distribute disposable bioreactor systems for biopharmaceutical applications. 2008-11-14T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566144null HTML http://biopharminternational.findpharma.com/biopharm/Novartis-Licenses-Oxfordrsquos-Meningococcus-Vacci/ArticleStandard/Article/detail/566142?ref=25 Isis Innovation (Oxford, UK), the University of Oxford’s technology transfer company, has licensed patents based on the work of Oxford Professor Richard Moxon’s research group and research by Canada’s National Research Council Institute for Biological Science to Novartis Vaccines and Diagnostics. 2008-11-14T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566142null HTML http://biopharminternational.findpharma.com/biopharm/GE-Healthcare-and-BAC-Expand-Collaboration/ArticleStandard/Article/detail/566146?ref=25 BAC BV (Naarden, The Netherlands) has announced the expansion of its collaboration with GE Healthcare with the addition of new bioprocess affinity chromatography media to GE Healthcare’s range of custom-designed media. 2008-11-14T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566146null HTML http://biopharminternational.findpharma.com/biopharm/MedImmune-Licenses-Technology-to-Hungarys-Omninves/ArticleStandard/Article/detail/566141?ref=25 MedImmune (Gaithersburg, MD) has licensed its proprietary reverse genetics intellectual property to Omninvest, a Hungarian research and manufacturing company, to support the development and construction of new vaccine strains to produce non-live human influenza vaccines. 2008-11-14T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566141null HTML http://biopharminternational.findpharma.com/biopharm/Todd-McLaren-Joins-Hyde-as-a-Senior-Vice-President/ArticleStandard/Article/detail/566151?ref=25 Todd McLaren has joined Hyde Engineering + Consulting, Inc. as senior vice president of marketing and new business development with overall responsibility for the east coast. 2008-11-14T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566151null HTML http://biopharminternational.findpharma.com/biopharm/Cinryze-Receives-FDA-Approval-for-Prophylaxis-Agai/ArticleStandard/Article/detail/566133?ref=25 The US Food and Drug Administration (FDA) has approved New York City-based Lev Pharmaceuticals’ Cinryze [C1 inhibitor (human)] for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema (HAE), also known as C1 inhibitor deficiency. 2008-11-14T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566133null HTML http://biopharminternational.findpharma.com/biopharm/Argos-Develops-Disposable-Hood-for-Personalized-Th/ArticleStandard/Article/detail/566130?ref=25 A major problem in personalized medicine has been scale-up. 2008-11-14T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566130null HTML http://biopharminternational.findpharma.com/biopharm/John-P-McLaughlin-Appointed-to-Head-Up-PDL-Spin-Of/ArticleStandard/Article/detail/566150?ref=25 PDL BioPharma, Inc. (PDL, Redwood City, CA) has appointed John P. McLaughlin to become president and chief executive officer (CEO) following the company’s planned spin-off of its biotechnology assets. 2008-11-14T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566150null HTML http://biopharminternational.findpharma.com/biopharm/Frederic-Chereau-Appointed-Pervasis-President-and-/ArticleStandard/Article/detail/566149?ref=25 Frederic Chereau has been named president and chief executive officer of Pervasis Therapeutics, Inc. (Cambridge, MA). 2008-11-14T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566149null HTML http://biopharminternational.findpharma.com/biopharm/FDA-Grants-Full-Approval-to-ONTAK-for-Use-in-Patie/ArticleStandard/Article/detail/566137?ref=25 The US Food and Drug Administration (FDA) has approved an efficacy supplemental biologics license application (sBLA) for Eisai Corporation of North America’s (Woodcliff Lake, NJ) ONTAK (denileukin diftitox). 2008-11-14T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566137null HTML http://biopharminternational.findpharma.com/biopharm/Sartorius-Stedim-Biotech-Acquires-Wave-Biotech/ArticleStandard/Article/detail/566147?ref=25 Sartorius Stedim Biotech GmbH (SSB, Goettingen, Germany) has acquired the Swiss-based company, Wave Biotech AG (Tagelswangen, Switzerland). 2008-11-14T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566147null HTML http://biopharminternational.findpharma.com/biopharm/Laureate-to-Manufacture-Antibodies-for-Tolerx-and-/ArticleStandard/Article/detail/566148?ref=25 Laureate Pharma, Inc. (Princeton, NJ), has entered into contract manufacturing agreements with Tolerx, Inc. (Cambridge, MA), and Tolera Therapeutics, Inc. (Kalamazoo, MI). 2008-11-14T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566148null HTML http://biopharminternational.findpharma.com/biopharm/FDA-Awards-NIPTE-119-Million-Contract-to-Help-Deve/ArticleStandard/Article/detail/566106?ref=25 The US Food and Drug Administration (FDA) has awarded the National Institute for Pharmaceutical Technology and Education (NIPTE, West Lafayette, IN) a contract to develop the science behind Quality by Design (QbD) and design space specifications 2008-11-14T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566106null HTML http://biopharminternational.findpharma.com/biopharm/GlaxoSmithKline-Acquires-Rights-to-Vaccine-for-Alz/ArticleStandard/Article/detail/566139?ref=25 GlaxoSmithKline Biologicals S.A. (GSK, London, UK) and AFFiRiS GmbH (Vienna, Austria) have announced a collaboration agreement that grants GSK exclusive rights to AFFiRiS’s Alzheimer’s disease vaccine programs that aims at treating Alzheimer’s by targeting the beta-amyloid protein. 2008-11-14T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566139null HTML http://biopharminternational.findpharma.com/biopharm/Bayers-New-Sterile-Fill-Facility-Receives-EMEA-FDA/ArticleStandard/Article/detail/566135?ref=25 The European Medicines Agency (EMEA) has granted license approval to Bayer HealthCare LLC (Bayer, Berkeley, CA) for its new sterile filling facility on its Berkeley, CA, campus. 2008-11-14T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566135null HTML http://biopharminternational.findpharma.com/biopharm/Disposables+Articles/Lifecycle-Cost-Analysis-for-Single-Use-Systems/ArticleStandard/Article/detail/566011?ref=25 This article describes a quick method for evaluating lifecycle costs for single-use systems against their more conventional stainless-steel counterparts. 2008-11-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566011null XML http://biopharminternational.findpharma.com/biopharm/Disposables+Articles/Disposables-for-Bioprocessing-Making-the-Transitio/ArticleStandard/Article/detail/566013?ref=25 Transitioning from stainless steel technology to disposable technology in bioprocessing. 2008-11-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566013null XML http://biopharminternational.findpharma.com/biopharm/Disposables+Articles/Systematic-Evaluation-of-Single-Use-Systems-Using-/ArticleStandard/Article/detail/566015?ref=25 This article describes the steps required to build a comprehensive model in a batch process simulator for a process that uses single-use systems for buffer preparation and storage. 2008-11-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566015null XML http://biopharminternational.findpharma.com/biopharm/Disposables+Articles/The-Environmental-Impact-of-Disposable-Technologie/ArticleStandard/Article/detail/566014?ref=25 Can disposables reduce your facility's environmental footprint? We have compared the environmental footprint of a traditional biopharmaceutical manufacturing facility using fixed-in-place stainless steel equipment, and a facility implementing disposable technologies for cell culture, solution mixing and hold, product hold, and liquid transfer. 2008-11-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566014null XML http://biopharminternational.findpharma.com/biopharm/Disposables+Articles/Disposable-Bioreactors-for-Cells-and-Microbes/ArticleStandard/Article/detail/566012?ref=25 Productivities similar to those achieved with stirred tanks can be achieved with disposable bioreactors. 2008-11-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566012null XML http://biopharminternational.findpharma.com/biopharm/From+the+Editor/The-Environmental-Impact-of-Disposables/ArticleStandard/Article/detail/566016?ref=25 Despite creating plastic waste, the disposables option is better for the environment. 2008-11-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566016null XML http://biopharminternational.findpharma.com/biopharm/Quality/Statistical-EssentialsmdashPart-4-Regression-and-D/ArticleStandard/Article/detail/566021?ref=25 Well-designed experiments can reduce the risk of coming to an incorrect conclusion during a process characterization, assay validation, or process validation study. 2008-11-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566021null XML http://biopharminternational.findpharma.com/biopharm/Regulatory+Compliance+Articles/Nanotechnology-Creates-Opportunities-Challenges-fo/ArticleStandard/Article/detail/566017?ref=25 The FDA and other regulatory authorities are evaluating new regulations to ensure the safety and quality of nanomaterials in biomedical products. 2008-11-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566017null XML http://biopharminternational.findpharma.com/biopharm/Regulatory+Compliance+Articles/Global-QA-and-Regulatory-Compliance-The-Business-C/ArticleStandard/Article/detail/566025?ref=25 A centralized quality control strategy may be the best solution. 2008-11-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566025/200494108-001_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Operations+Articles/Applying-Operational-Excellence-Concepts-to-Biopha/ArticleStandard/Article/detail/566024?ref=25 Translate the concepts in to practical applications and reduce waste. 2008-11-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566024/bp1108_opex_bioprocessing_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Quality/Aggregates-in-MAbs-and-Recombinant-Therapeutic-Pro/ArticleStandard/Article/detail/566023?ref=25 FDA perspectives on specs and effective control strategies. 2008-11-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566023/BP1108_MAb_aggregates_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Expansion+%26+Management+Articles/Biomanufacturing-Capacity-Quandary/ArticleStandard/Article/detail/566019?ref=25 There could be a serious glut of commercial scale mammalian cell culture capacity over the next five years. Then again, there could be a significant shortage. It all depends on how things develop in expression technology, the new product pipeline, and corporate strategies. 2008-11-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566019null XML http://biopharminternational.findpharma.com/biopharm/Legal+Briefs/Top-10-Legal-Issues-Biotech-Start-Ups-Must-Address/ArticleStandard/Article/detail/566022?ref=25 A top-10 list of critical legal issues that biotech start-ups should make an effort to address, even when the capital squeeze is intense. 2008-11-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566022null XML http://biopharminternational.findpharma.com/biopharm/Disposables+Articles/The-Challenges-and-Benefits-of-Disposable-Technolo/ArticleStandard/Article/detail/566026?ref=25 Interview with David Radspinner, director of global marketing & customer applications, bioprocess production at Thermo Fisher Scientific. 2008-11-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566026null XML http://biopharminternational.findpharma.com/biopharm/Expansion+%26+Management+Articles/The-Company-at-the-Crossroads-Part-2-Build-or-Buy/ArticleStandard/Article/detail/566020?ref=25 When making critical decisions such as whether to build or buy critical capabilities, companies need a decision-making approach that weighs risks and rewards as a science with adequate inputs, repeatable processes, and measurable results. The method must also accommodate the human factor by encouraging wide participation and providing the kind of neutral decision criteria that satisfies participants about the objectivity of the process. 2008-11-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566020null XML http://biopharminternational.findpharma.com/biopharm/India+Today/Contract-Manufacturing-in-India-Is-the-CMO-Model-a/ArticleStandard/Article/detail/566018?ref=25 If Indian biologics manufacturers can establish a track record for recombinant products, enhance quality image, maintain cost competitiveness, and demonstrate technology transfer and regulatory knowhow, they are likely to be in the middle of the next boom in biologics manufacturing. 2008-11-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566018null XML http://biopharminternational.findpharma.com/biopharm/Business/Applying-Operational-Excellence-Concepts-to-Biopha/ArticleStandard/Article/detail/565373?ref=25 Supplemental tables for the above-mentioned article, providing additional information about the application of operational excellence methods. 2008-11-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/565373null PDF http://biopharminternational.findpharma.com/biopharm/BioPharm-2009-Media-Kit/ArticleStandard/Article/detail/559013?ref=25 BioPharm Media Kit 2009 2008-10-15T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/422008/559013null PDF http://biopharminternational.findpharma.com/biopharm/UMass-Genzyme-Focus-on-Biopharmaceutical-Manufactu/ArticleStandard/Article/detail/557131?ref=25 Massachusetts continued to establish itself as an important hub for biopharmaceutical research and product development with the opening of the University of Massachusetts Lowell’s (UMass Lowell) fully automated BioManufacturing Pilot Plant and Genzyme’s (Cambridge, MA) new Science Center in September. 2008-10-08T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412008/557131null HTML http://biopharminternational.findpharma.com/biopharm/BioPharm-2009-Corp-Cap-promo/ArticleStandard/Article/detail/557384?ref=25 2009 Corp Cap Promo 2008-10-08T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412008/557384null PDF http://biopharminternational.findpharma.com/biopharm/Morgan-Sheng-Appointed-VP-Neuroscience-Research-at/ArticleStandard/Article/detail/557138?ref=25 Genentech, Inc. (South San Francisco, CA) has appointed Morgan Sheng, MD, PhD, vice president, neuroscience. 2008-10-08T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412008/557138null HTML http://biopharminternational.findpharma.com/biopharm/Eli-Lilly-to-Acquire-ImClone-for-65-Billion/ArticleStandard/Article/detail/557132?ref=25 The boards of directors of Eli Lilly and Company (Indianapolis, IN) and ImClone Systems, Inc. (New York, NY) have approved a definitive merger agreement under which Lilly will acquire ImClone through an all cash tender offer of $70.00 per share, or approximately $6.5 billion. 2008-10-08T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412008/557132null HTML http://biopharminternational.findpharma.com/biopharm/New-Investments-Revive-Hopes-for-Plant-Made-Pharma/ArticleStandard/Article/detail/557129?ref=25 New investments by two different pharmaceutical companies in programs to manufacture biologics in tobacco plants are reviving hope in the promise of plant-made pharmaceuticals. 2008-10-08T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412008/557129null HTML http://biopharminternational.findpharma.com/biopharm/FDA-Approves-Talecrisrsquos-Neurologic-Drug/ArticleStandard/Article/detail/557130?ref=25 The US Food and Drug Administration has approved Talecris Biotherapeutics’ (Research Triangle Park, NC) Gamunex as a treatment for chronic inflammatory demyelinating polyneuropathy (CIDP). 2008-10-08T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412008/557130null HTML http://biopharminternational.findpharma.com/biopharm/FDA-Clears-New-CDC-Test-to-Detect-Human-Influenza/ArticleStandard/Article/detail/557133?ref=25 A new test developed by the US Centers for Disease Control and Prevention (CDC) to diagnose human influenza infections and the highly pathogenic influenza A (H5N1) viruses has been cleared by the FDA. 2008-10-08T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412008/557133null HTML http://biopharminternational.findpharma.com/biopharm/Rainer-Lichtenberger-Appointed-CEO-of-CEVEC-Pharma/ArticleStandard/Article/detail/557137?ref=25 Rainer Lichtenberger, PhD, has been appointed the new chief executive officer of CEVEC Pharmaceuticals (Cologne, Germany). 2008-10-08T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412008/557137null HTML http://biopharminternational.findpharma.com/biopharm/BioPharm-2009-e-media-kit/ArticleStandard/Article/detail/557305?ref=25 BioPharm 2009 e-media kit 2008-10-08T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412008/557305null PDF http://biopharminternational.findpharma.com/biopharm/Nomad-Bioscience-Inks-Licensing-Pact-with-Bayer-In/ArticleStandard/Article/detail/557136?ref=25 Nomad Bioscience GmbH (Munich, Germany) has entered into a broad licensing agreement with Bayer Innovation GmbH (Düsseldorf, Germany) and Icon Genetics group (Halle, Germany). 2008-10-08T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412008/557136null HTML http://biopharminternational.findpharma.com/biopharm/MedImmune-Licenses-Reverse-Genetics-Technology-to-/ArticleStandard/Article/detail/557134?ref=25 MedImmune (Gaithersburg, MD) has licensed its proprietary reverse genetics intellectual property to BIKEN, the Research Foundation for Microbial Diseases of Osaka University in Japan, to support the development of new vaccine strains to produce non-live human influenza vaccines. 2008-10-08T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412008/557134null HTML http://biopharminternational.findpharma.com/biopharm/Texas-AampM-and-XOMA-to-Develop-Next-Generation-Bi/ArticleStandard/Article/detail/557135?ref=25 The Texas A&M University System (College Station, Texas) and XOMA, Ltd., (Berkeley, CA), have signed an agreement to explore options for developing and manufacturing antibodies and protein-based therapeutics for human and veterinary applications. 2008-10-08T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412008/557135null HTML http://biopharminternational.findpharma.com/biopharm/News/Western-Pharma-Companies-Insource-from-Asia-to-Red/ArticleStandard/Article/detail/557128?ref=25 To reduce the risks involved in outsourcing pharmaceutical operations to Asia, many Western firms are increasingly taking an “insourcing” approach, a new report says. 2008-10-08T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412008/557128null HTML http://biopharminternational.findpharma.com/biopharm/News/Eli-Lilly-to-Acquire-ImClone-for-65-Billion/ArticleStandard/Article/detail/556694?ref=25 Eli Lilly acquires Imclone 2008-10-06T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412008/556694null HTML http://biopharminternational.findpharma.com/biopharm/News/Eli-Lilly-in-Talks-to-Acquire-ImClone-for-61-Billi/ArticleStandard/Article/detail/556309?ref=25 Eli Lilly (Indianapolis, In) is the mystery bidder "in advanced talks" to acquire ImClone Systems (New York, NY). 2008-10-03T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/402008/556309null HTML http://biopharminternational.findpharma.com/biopharm/Vaccine+Manufacturing+Articles/Bridging-the-Gap-in-Translational-Research-for-Vac/ArticleStandard/Article/detail/557307?ref=25 Interview with Roger Lias, president and group commercial director at Eden Biodesign, Inc. 2008-10-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412008/557307null XML http://biopharminternational.findpharma.com/biopharm/Vaccine+Manufacturing+Articles/Preparedness-for-Pandemic-Flu-Outbreak-A-Case-for-/ArticleStandard/Article/detail/557308?ref=25 To succeed in a pandemic flu outbreak, the biopharmaceutical industry must unite, disregard proprietary and competitive issues, and forge a preparedness plan to ensure adequate vaccines. 2008-10-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412008/557308null XML http://biopharminternational.findpharma.com/biopharm/Vaccine+Manufacturing+Articles/Formulation-Studies-of-an-Adsorbed-Conjugate-Vacci/ArticleStandard/Article/detail/557387?ref=25 NeisVac-C is a polysaccharide-protein conjugate vaccine for use against Neisseria meningitidis serogroup C infection. The Phase 1 clinical formulation consisted of physiological saline, thimerosal, and aluminum hydroxide. The long-term stability data for both the PBS and saline formulations are presented in this article. 2008-10-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412008/557387null XML http://biopharminternational.findpharma.com/biopharm/Vaccine+Manufacturing+Articles/Vaccines-Incorporating-Toll-Like-Receptor-Ligands/ArticleStandard/Article/detail/557310?ref=25 This article discusses the production process of the major influenza antigen, hemagglutinin (HA), by rDNA methods in E. coli. 2008-10-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412008/557310null XML http://biopharminternational.findpharma.com/biopharm/Vaccine+Manufacturing+Articles/Developing-and-Manufacturing-Attenuated-Live-Bacte/ArticleStandard/Article/detail/557306?ref=25 There are a number of specific characteristics to be considered when developing and manufacturing live bacterial vaccines. 2008-10-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412008/557306null XML http://biopharminternational.findpharma.com/biopharm/Vaccine+Manufacturing+Articles/Manufacturing-Process-Development-for-an-Epidermal/ArticleStandard/Article/detail/557900?ref=25 The Center for Molecular Immunology (Havana, Cuba) has been working on a novel cancer immunotherapy targeting the epidermal growth factor (EGF). The vaccine is composed of a chemical conjugate of EGF and a carrier protein (rP64k), designed to trigger an anti-EGF antibody response. The results of studies of molecular characterization, immunogenic activity, and clinical data are presented here. 2008-10-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412008/557900null XML http://biopharminternational.findpharma.com/biopharm/Vaccine+Manufacturing+Articles/Developing-Plasmid-DNA-Vaccines/ArticleStandard/Article/detail/557309?ref=25 Interview with Magda Marquet, co-CEO and co-president of Althea Technologies 2008-10-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412008/557309null XML http://biopharminternational.findpharma.com/biopharm/Manufacturing+Economics+Articles/Disposable-Decisions/ArticleStandard/Article/detail/557242?ref=25 To achieve the right balance between disposable and reuseable options, companies must consider important technical and economic factors. 2008-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412008/557242null XML http://biopharminternational.findpharma.com/biopharm/Manufacturing+Economics+Articles/Biopharmaceuticals-Approval-Trends-in-2007/ArticleStandard/Article/detail/557248?ref=25 The year 2007 witnessed the approval of fifteen biopharmaceuticals in the United States and European Union. 2008-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412008/557248/BP1008_product_approvals_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/GMPs%2FValidation/Strengthening-the-Chain-Addressing-Pedigree-Challe/ArticleStandard/Article/detail/557246?ref=25 Despite the current regulatory uncertainty, pharmaceutical companies should move forward with planning for serialization and pedigree. 2008-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412008/557246null XML http://biopharminternational.findpharma.com/biopharm/Manufacturing+Economics+Articles/Biotech-Cruises-On-Despite-a-Turbulent-Economic-Cl/ArticleStandard/Article/detail/557247?ref=25 The biotech industry's year-to-date report card contains good grades despite the turbulent economic climate. 2008-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412008/557247null XML http://biopharminternational.findpharma.com/biopharm/India+Today/Pharmaceutical-Distribution-in-India/ArticleStandard/Article/detail/557245?ref=25 The rapid growth of the pharmaceutical industry in India is yet to create significant changes in the Indian distribution system. 2008-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412008/557245null XML http://biopharminternational.findpharma.com/biopharm/Quality/FDA-Promotes-QbD-for-Biotech-Therapies/ArticleStandard/Article/detail/557244?ref=25 The FDA's QbD pilot program is supporting good manufacturing on a global basis. 2008-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412008/557244null XML http://biopharminternational.findpharma.com/biopharm/From+the+Editor/Sick-Economy-Sick-Healthcare-System/ArticleStandard/Article/detail/557243?ref=25 The country is reeling from US Treasury Secretary Henry Paulson's proposed $700 billion Wall Street bailout. In appealing for support, Paulson stressed this was a crisis. This sense of urgency is reminiscent of the way millions of Americans without health insurance cope with medical problems—in the emergency room, because they have no access to routine and preventive care. 2008-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412008/557243null XML http://biopharminternational.findpharma.com/biopharm/Protein+Expression+Articles/Detection-of-Cache-Valley-Virus-in-Biologics-Manuf/ArticleStandard/Article/detail/557250?ref=25 Avoid manufacturing failures by effective viral inactivation. 2008-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412008/557250/bp1008_Nims_Vero_Cells_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Manufacturing+Economics+Articles/Where-is-Biopharmaceutical-Manufacturing-Heading/ArticleStandard/Article/detail/557249?ref=25 An analysis of current and upcoming industry challenges. 2008-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412008/557249/BP1008_downstream_process_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/News/ImClone-Rejects-Bristol-Myers-Offer/ArticleStandard/Article/detail/548998?ref=25 Biotechnology company ImClone Systems (New York, NY) has rejected the offer it received last month from its cancer drug partner Bristol-Myers (BMS, New York, NY) to acquire ImClone for $60 per share. 2008-09-10T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/372008/548998null HTML http://biopharminternational.findpharma.com/biopharm/HGS-Partners-with-Hospira-and-Eden-Biodesign-to-Ma/ArticleStandard/Article/detail/548806?ref=25 Human Genome Sciences (HGS, Rockville, MD, www.hgsi.com) has recently entered into manufacturing partnerships with Hospira (Lake Forcest, IL, www.hospira.com) and Eden Biodesign (Liverpool, UK, www.edenbiodesign.com). 2008-09-10T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/372008/548806null HTML http://biopharminternational.findpharma.com/biopharm/Scott-Neilson-Appointed-Chief-Operating-Officer-of/ArticleStandard/Article/detail/548602?ref=25 Scott Neilson has been appointed to the position of Chief Operating Officer of AAIPharma. 2008-09-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/372008/548602null HTML http://biopharminternational.findpharma.com/biopharm/Pall-Acquires-Molecular-Diagnostics-Manufacturer-G/ArticleStandard/Article/detail/548601?ref=25 Pall Corporation (East Hills, NY) has purchased GeneSystems (Bruz, France), a privately held biotechnology company that has developed a molecular diagnostics platform. 2008-09-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/372008/548601null HTML http://biopharminternational.findpharma.com/biopharm/Robert-Leisk-Joins-Biokinetics-as-Senior-Vice-Pres/ArticleStandard/Article/detail/548604?ref=25 Robert Leisk has joined Biokinetics as a senior vice president responsible for international biopharmaceutical business development for projects emanating from North America. 2008-09-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/372008/548604null HTML http://biopharminternational.findpharma.com/biopharm/News/North-Carolina-Biotechnology-Center-Announces-Comp/ArticleStandard/Article/detail/548596?ref=25 The North Carolina Biotechnology Center has announced the five sponsoring companies chosen for the first year of its Industrial Fellowship Program. 2008-09-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/372008/548596null HTML http://biopharminternational.findpharma.com/biopharm/News/Artelis-and-Selexis-Announce-31-gL-Yields-in-Multi/ArticleStandard/Article/detail/548595?ref=25 Artelis SA (Brussels, Belgium) and Selexis SA (Geneva, Switzerland) have announced  manufacturing yields of more than 31 grams per liter in a CHO-based monoclonal antibody production process, in multiple harvests from a perfusion-like process. 2008-09-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/372008/548595null HTML http://biopharminternational.findpharma.com/biopharm/Christopher-S-Henney-Appointed-Chairman-of-Anthera/ArticleStandard/Article/detail/548606?ref=25 Christopher S. Henney has been appointed chairman of the board of Anthera Pharmaceuticals Inc. (San Mateo, CA). 2008-09-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/372008/548606null HTML http://biopharminternational.findpharma.com/biopharm/Novavax-Announces-Favorable-Results-From-Phase-12a/ArticleStandard/Article/detail/548597?ref=25 Novavax, Inc. (Rockville, MD) has announced favorable results from the second stage of the Phase 1/2a human clinical trial of its pandemic influenza virus-like particle (VLP) vaccine candidate. 2008-09-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/372008/548597null HTML http://biopharminternational.findpharma.com/biopharm/Pfizer-Signs-Vaccine-Agreement-with-Cytos/ArticleStandard/Article/detail/548599?ref=25 Cytos Biotechnology AG (Schlieren, Switzerland) has entered into an exclusive global research, option, and license agreement with Pfizer Vaccines LLC (Pfizer, New York, NY) to research, develop, manufacture, and commercialize novel vaccines for a defined number of human diseases. 2008-09-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/372008/548599null HTML http://biopharminternational.findpharma.com/biopharm/Pfizer-and-Medivation-to-Co-Develop-and-Market-Alz/ArticleStandard/Article/detail/548600?ref=25 Pfizer Inc. (New York, NY) and Medivation, Inc. (San Francisco, CA) have joined forces to develop and commercialize Dimebon, Medivation’s investigational drug for treating Alzheimer’s disease and Huntington’s disease. 2008-09-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/372008/548600null HTML http://biopharminternational.findpharma.com/biopharm/Upstream++Processing+Whitepapers/Fermentation-Process-Monitoring-II-Mammalian-Cell-/ArticleStandard/Article/detail/547528?ref=25 In-situ FTIR spectroscopy using a sterilizable sampling head is an ideal method for monitoring bioprocesses such as mammalian cell cultures, making it possible to track nutrients and waste products in real time. 2008-09-03T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/362008/547528null REMOTE http://biopharminternational.findpharma.com/biopharm/GMPs%2FValidation+Whitepapers/Cleaning-Validation-On-Site-Trials-of-SpotViewR/ArticleStandard/Article/detail/547526?ref=25 Abstract: Surface analysis using grazing-angle FTIR spectroscopy provides an in-situ, real-time method for cleaning validation. Recent trials at three manufacturing facilities show that the method works well under real-life conditions. 2008-09-03T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/362008/547526null REMOTE http://biopharminternational.findpharma.com/biopharm/Upstream++Processing+Whitepapers/Fermentation-Process-Monitoring-Dissolved-Carbon-D/ArticleStandard/Article/detail/547529?ref=25 In-situ FTIR spectroscopy provides a direct view of the "vital signs" inside a fermenter. Tracking dissolved carbon dioxide is an important part of this monitoring method. 2008-09-03T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/362008/547529null REMOTE http://biopharminternational.findpharma.com/biopharm/Regulatory+Beat/Global-Manufacturing-Challenges-Industry-Regulator/ArticleStandard/Article/detail/545362?ref=25 The heparin debacle and other crises involving imported drugs and biologics has put pressure on the US FDA to step up its oversight of foreign drug manufacturing. 2008-09-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/352008/545362null XML http://biopharminternational.findpharma.com/biopharm/GMPs%2FValidation/The-Art-of-the-Deal/ArticleStandard/Article/detail/545356?ref=25 Risk mitigation should be a key aspect of any contract manufacturing organization's business strategy. 2008-09-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/352008/545356null XML http://biopharminternational.findpharma.com/biopharm/Quality/Minimizing-the-Problem-of-OOS/ArticleStandard/Article/detail/545363?ref=25 Statistical methods for calculating confidence intervals, tolerance intervals, and capability analysis to reduce out-of-specification situations. 2008-09-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/352008/545363null XML http://biopharminternational.findpharma.com/biopharm/Fermentation+%26+Cell+Culture+Articles/Viral-Clearance-Strategy-Using-a-Three-Tier-Orthog/ArticleStandard/Article/detail/545360?ref=25 How to implement a risk-based approach to eliminating viruses. 2008-09-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/352008/545360/bp0908_Tarrach_ViralClearance_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Legal+Briefs/Protecting-Patents-for-Personalized-Medicine/ArticleStandard/Article/detail/545358?ref=25 There are several challenges associated with protecting patents for personalized medicines. 2008-09-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/352008/545358null XML http://biopharminternational.findpharma.com/biopharm/From+the+Editor/The-Outlook-for-Quality-by-Design/ArticleStandard/Article/detail/545361?ref=25 The complexity of Quality by Design leads naturally to questions of how much work it requires, how many companies have the resources to do it, and what the payoff is for anybody. 2008-09-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/352008/545361null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing+Articles/Plasmid-DNA-Recovery-Using-Size-Exclusion-and-Perf/ArticleStandard/Article/detail/545359?ref=25 Scalable method to recover plasmid-DNA. 2008-09-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/352008/545359/bp0908_Plasmid_DNA_Recovery_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Regulatory+Compliance+Articles/The-Company-at-the-Crossroads-Part-1-To-Commercial/ArticleStandard/Article/detail/545357?ref=25 Every biotech company reaches a point in its development where it must decide what path it will take after it passes the start-up phase. This article discusses what the company must consider to decide what business model it will follow. 2008-09-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/352008/545357null XML http://biopharminternational.findpharma.com/biopharm/Upstream++Processing+Whitepapers/Global-Biochemical-Profiling-for-Bioprocessing-Opt/ArticleStandard/Article/detail/523788?ref=25 It is widely understood that the production phase of bioprocessing can have a significant impact on the overall profitability of the biopharmaceutical. Organizations must analyze everything from total protein production level to glycosylation patterns as well as overall quality and stability. Given the large numbers of variables involved?especially in the composition of media nutrients?it is has been difficult to achieve globally optimal conditions using traditional analysis methods. This paper provides an overview of the type of relevant information that global biochemical profiling (metabolomics) can provide. Through this global analysis, one can not only measure these changes but also put them into biological context and?most importantly?into application. 2008-08-26T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242008/523788null REMOTE http://biopharminternational.findpharma.com/biopharm/Whitepapers/Final-Bulk-Inspection-of-Solid-Dose-Pharmaceutical/ArticleStandard/Article/detail/543458?ref=25 Final bulk inspection of solid-dose OTC and regulated pharmaceuticals must deliver consistently high product quality. Customers scrutinize products closely, and processes are increasingly coming under the review of regulatory agencies. Advanced technology addresses these challenges, as new automated continuous inspection systems are more effective and commercially viable than ever before. 2008-08-20T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/342008/543458null REMOTE http://biopharminternational.findpharma.com/biopharm/News/Chemists-Developing-Fully-Synthetic-Form-of-Hepari/ArticleStandard/Article/detail/542860?ref=25 Chemists are reporting a major advance toward developing a safer, fully-synthetic version of heparin, the widely used blood thinner currently produced from pig intestines. 2008-08-18T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/342008/542860null HTML http://biopharminternational.findpharma.com/biopharm/News/Genentech-Rejects-Roche-Proposal/ArticleStandard/Article/detail/542309?ref=25 The American biotech giant Genentech, Inc. has rejected an offer by the Swiss drug-maker Roche to acquire the 44% of Genentech it does not already own, but said it would be willing to consider a higher bid. 2008-08-14T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/332008/542309null HTML http://biopharminternational.findpharma.com/biopharm/Bridge-Laboratories-to-Build-Second-Facility-in-Be/ArticleStandard/Article/detail/535284?ref=25 Bridge Laboratories (Gaithersburg, MD), a preclinical contract research organization, will build its second preclinical facility in China. 2008-08-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/332008/535284null HTML http://biopharminternational.findpharma.com/biopharm/News/FDA-Approves-2008ndash2009-Flu-Vaccines/ArticleStandard/Article/detail/535356?ref=25 The US Food and Drug Administration has approved this year’s seasonal influenza vaccines that include new strains of the virus likely to cause the flu in the US during the 2008–2009 season. 2008-08-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/332008/535356null HTML http://biopharminternational.findpharma.com/biopharm/News/FDA-Launches-Fellowship-Program-to-Develop-Pipelin/ArticleStandard/Article/detail/535286?ref=25 The US Food and Drug Administration is launching a two-year fellowship program aimed at attracting scientists, engineers, and health professionals to the agency. 2008-08-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/332008/535286null HTML http://biopharminternational.findpharma.com/biopharm/Denny-Kraichely-Joins-Editorial-Advisory-Board-of-/ArticleStandard/Article/detail/535290?ref=25 Denny Kraichely, PhD, principal research scientist and group leader of pharmaceutical development and marketed product support at Centocor R&D, Inc. (Radnor, PA), a Johnson & Johnson Company, has joined the Editorial Advisory Board of BioPharm International. 2008-08-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/332008/535290null HTML http://biopharminternational.findpharma.com/biopharm/Florida-Biologix-Signs-cGMP-Agreement-with-Nationa/ArticleStandard/Article/detail/535288?ref=25 Florida Biologix (Alachua, FL), a biopharmaceutical development and contract manufacturing organization, has entered into a current good manufacturing practices (cGMP) manufacturing agreement with the National Taiwan University Hospital (Taipei, Taiwan). 2008-08-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/332008/535288null HTML http://biopharminternational.findpharma.com/biopharm/Eric-Langer-Joins-Editorial-Advisory-Board-of-emBi/ArticleStandard/Article/detail/535292?ref=25 Eric S. Langer, president and managing partner at BioPlan Associates, Inc. (Rockville, MD) has joined the Editorial Advisory Board of BioPharm International. 2008-08-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/332008/535292null HTML http://biopharminternational.findpharma.com/biopharm/News/Pfizer-to-Close-Manufacturing-Plant-in-Ireland/ArticleStandard/Article/detail/535285?ref=25 Pfizer (New York, NY) has announced plans to close its manufacturing plant located at Little Island, Ireland, after a failed attempt to find a buyer for the facility. 2008-08-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/332008/535285null HTML http://biopharminternational.findpharma.com/biopharm/News/HHS-and-DHS-Announce-Guidance-on-Pandemic-Vaccinat/ArticleStandard/Article/detail/535359?ref=25 The US Departments of Health and Human Services (HHS) and Homeland Security (DHS) have released guidance on allocating and targeting pandemic influenza vaccine. 2008-08-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/332008/535359null HTML http://biopharminternational.findpharma.com/biopharm/Gail-Sofer-emBioPharmem-EAB-Member-Retires-from-GE/ArticleStandard/Article/detail/535291?ref=25 Gail Sofer, a member of BioPharm International’s Editorial Advisory Board, has retired from her position as director of regulatory compliance at GE Healthcare. 2008-08-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/332008/535291null HTML http://biopharminternational.findpharma.com/biopharm/Roche-Acquires-Arius-Gains-Access-to-Antibody-Ther/ArticleStandard/Article/detail/535287?ref=25 Roche (Basel, Switzerland) will acquire Arius Research Inc. (Toronto, Canada) in an all-cash transaction for approximately $190 million. 2008-08-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/332008/535287null HTML