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. 2008-05-13T05:07:04Z http://biopharminternational.findpharma.com/biopharm/Downstream+Processing+Whitepapers/Asset-Management-for-Growing-Biotech-Companies/ArticleStandard/Article/detail/516024?ref=25 The biotechnology industry has mushroomed over the past decade, with revenues increasing from $8 billion in 1992 to $39 billion in 2003,1 and it shows no signs of slowing down. New therapeutics are entering and pressing through clinical trials. Treatments are emerging from clinical trials ready for marketing and scaling up for commercial production, leading to a growing need for new facilities. 2008-05-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/192008/516024null REMOTE http://biopharminternational.findpharma.com/biopharm/FDA-Appoints-Frank-M-Torti-to-Senior-Leadership-Po/ArticleStandard/Article/detail/515568?ref=25 Frank M. Torti, MD, has been appointed principal deputy commissioner and first ever chief scientist at the FDA. 2008-05-08T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/192008/515568null HTML http://biopharminternational.findpharma.com/biopharm/News/Merck-Receives-Warning-Letter-for-Vaccine-Operatio/ArticleStandard/Article/detail/515547?ref=25 The FDA issued a warning letter to Merck and Co. (Whitehouse Station, NJ) on April 28, citing numerous GMP violations at Merck’s vaccine production operations in West Point, PA. 2008-05-08T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/192008/515547null HTML http://biopharminternational.findpharma.com/biopharm/News/DSM-Biologics-and-Upfront-to-Develop-a-Fully-Dispo/ArticleStandard/Article/detail/515562?ref=25 DSM Biologics (Heerlen, the Netherlands), and Upfront Chromatography A/S (Copenhagen, Denmark) have announced a collaboration to optimize Upfront’s new, fully disposable chromatography system for use with DSM's proprietary manufacturing technology. 2008-05-08T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/192008/515562null HTML http://biopharminternational.findpharma.com/biopharm/News/FDA-Finalizes-CMC-Guidance-for-Gene-Therapy-INDs/ArticleStandard/Article/detail/515558?ref=25 The FDA has issued its guidance for chemistry, manufacturing, and control information that is included in investigational new drug applications (INDs) for gene therapies, called “Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs).” 2008-05-08T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/192008/515558null HTML http://biopharminternational.findpharma.com/biopharm/News/Heparin-Products-the-Target-of-Deliberate-Adultera/ArticleStandard/Article/detail/515551?ref=25 Baxter’s heparin products appear to have been the target of a deliberate adulteration scheme, Baxter (Deerfield, IL) CEO Robert L. Parkinson said on April 29, 2008, in testimony before the US House of Representatives’ Committee on Energy and Commerce, Subcommittee on Oversight and Investigations. 2008-05-08T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/192008/515551null HTML http://biopharminternational.findpharma.com/biopharm/News/Genzyme-Recalls-Three-Lots-of-Thymoglobulin/ArticleStandard/Article/detail/515553?ref=25 On April 9, 2008, Genzyme Corporation (Framingham, MA) announced a recall of three lots of its organ-rejection antibody, Thymoglobulin, because of stability concerns. 2008-05-08T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/192008/515553null HTML http://biopharminternational.findpharma.com/biopharm/Robin-Robinson-Named-First-Director-of-BARDA/ArticleStandard/Article/detail/515569?ref=25 The Department of Health and Human Services has announced the selection of Robin Robinson, PhD, as the first director of the Biomedical Advanced Research Development Authority (BARDA), which was established in 2007 in the HHS Office of the Assistant Secretary for Preparedness and Response. 2008-05-08T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/192008/515569null HTML http://biopharminternational.findpharma.com/biopharm/News/Zelos-Therapeutics-and-Aegis-Therapeutics-Announce/ArticleStandard/Article/detail/515563?ref=25 Zelos Therapeutics, Inc. (West Conshohocken, PA) and Aegis Therapeutics LLC (San Diego, CA) have announced a collaboration for the development of an intranasal spray formulation of the proprietary parathyroid hormone (PTH) analog ZT-031 [Ostabolin-C, cyclic PTH-(1-31)]. 2008-05-08T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/192008/515563null HTML http://biopharminternational.findpharma.com/biopharm/News/Leached-Impurity-Found-in-Cubicin-Stored-in-Cardin/ArticleStandard/Article/detail/515552?ref=25 Cubist Pharmaceuticals, Inc. (Lexington, MA) informed healthcare professionals on April 4 that a potentially significant impurity, 2-mercaptobenzothiazole (MBT), has been isolated from reconstituted Cubicin stored in ReadyMED elastomeric infusion pumps manufactured by Cardinal Health, Inc. (Dublin, OH). 2008-05-08T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/192008/515552null HTML http://biopharminternational.findpharma.com/biopharm/News/Eli-Lilly-and-NIBRT-Enter-Research-Collaboration/ArticleStandard/Article/detail/515561?ref=25 The National Institute for Bioprocessing Research and Training (NIBRT, Dublin, Ireland) has entered into a new research collaboration with US pharmaceutical company Eli Lilly (Indianapolis, IN). 2008-05-08T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/192008/515561null HTML http://biopharminternational.findpharma.com/biopharm/News/Novavax-Reports-Positive-Results-from-Preclinical-/ArticleStandard/Article/detail/515559?ref=25 Novavax, Inc. (Rockville, MD) has received positive results from an immunogenicity study in ferrets inoculated with the company’s trivalent seasonal influenza vaccine candidate made using its proprietary virus-like particle (VLP) technology. 2008-05-08T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/192008/515559null HTML http://biopharminternational.findpharma.com/biopharm/Compliance+Notes/Coming-to-Biotech-Near-You-Quality-by-Design-Part-/ArticleStandard/Article/detail/513383?ref=25 The principles of QbD can be applied to biotech development and manufacturing to help resolve many common issues. QbD scientifically provides a greater understanding of the complex relationships among product quality attributes, the manufacturing process, and clinical safety and efficacy by determining the various permutations of critical input variables that will keep the product within specification. 2008-05-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182008/513383null XML http://biopharminternational.findpharma.com/biopharm/GMPs%2FValidation/An-Underfunded-FDA-Fights-Back/ArticleStandard/Article/detail/512658?ref=25 The FDA is under attack from all sides. Many influential members of Congress either don't trust the agency to monitor the industry appropriately, or have found it politically expedient to keep sounding alarms about inadequate oversight of food and drug safety and clinical research. The good news is that there seems to be a growing consensus that FDA needs a major infusion of cash to regain its stature as an effective science-based regulatory agency. 2008-05-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182008/512658null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Harvest-and-Recovery-of-MAbs-from-Large-Scale-Mamm/ArticleStandard/Article/detail/513386?ref=25 A comparison of primary harvest techniques. 2008-05-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182008/513386/0508_protein_purification_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Final+Word/Managing-the-Global-Supply-Chain/ArticleStandard/Article/detail/513407?ref=25 Recent problems with food and pharmaceutical ingredients sourced from China highlight a major disadvantage of our complex international supply chains for food and drug ingredients. A global supply chain offers more opportunities for accidental contamination as well as intentional adulteration and counterfeiting. Sticking to minimal requirements may not be enough. 2008-05-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182008/513407null XML http://biopharminternational.findpharma.com/biopharm/India+Today/Indias-Clinical-Trials-Market-Accelerates/ArticleStandard/Article/detail/512667?ref=25 Most local and global clinical research organizations (CROs) consider an operational presence in India as key to their overall business plans. India is clearly on course to become the next hub for clinical trials. 2008-05-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182008/512667null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Impact-of-Lot-to-Lot-Variability-of-Cation-Exchang/ArticleStandard/Article/detail/513395?ref=25 Understanding the impact on process performance. 2008-05-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182008/513395/0508_CEX_resin_variability_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Straightforward-Guidance/ArticleStandard/Article/detail/512655?ref=25 In the context of process validation, the confirmation of a belief must be checked repeatedly, throughout the product lifecycle. 2008-05-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182008/512655null XML http://biopharminternational.findpharma.com/biopharm/Outsourcing+Insights/Biomanufacturing-Pendulum-Swings-Toward-Overcapaci/ArticleStandard/Article/detail/512668?ref=25 The current overcapacity situation in the bio/pharmaceutical industry is a reminder that CMOs need to come up with business models and value propositions that are based on more than just selling capacity. 2008-05-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182008/512668null XML http://biopharminternational.findpharma.com/biopharm/Quality/Cumulative-Sum-Charts-for-Problem-Solving/ArticleStandard/Article/detail/514502?ref=25 CUSUM charts are easy to create in Excel and can reveal when a change occurred. 2008-05-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/192008/514502/0508_CUSUM_Bandurek_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/News/FDA-to-Recruit-1300-Science-and-Medical-Positions/ArticleStandard/Article/detail/513457?ref=25 The US FDA has embarked on a multiyear initiative to hire hundreds of individuals with science and medical backgrounds to help meet the agency?s responsibilities to ensure the safety and efficacy of human and veterinary drugs, biological products, medical devices, food, and cosmetics. 2008-04-30T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182008/513457null HTML http://biopharminternational.findpharma.com/biopharm/News/Heparin-Contamination-More-Widespread-than-First-T/ArticleStandard/Article/detail/511693?ref=25 The contamination of heparin is far more widespread, and began earlier, than first believed, FDA officials announced on April 21, 2008. 2008-04-22T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/172008/511693null HTML http://biopharminternational.findpharma.com/biopharm/Whitepapers/Cleaning-Validation-On-Site-Trials-of-SpotViewR/ArticleStandard/Article/detail/510957?ref=25 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. 2008-04-14T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/162008/510957null REMOTE http://biopharminternational.findpharma.com/biopharm/News/Takeda-to-Acquire-Millennium-for-88-Billion/ArticleStandard/Article/detail/509663?ref=25 Takeda Pharmaceutical Company Limited (Osaka, Japan) will acquire Millennium Pharmaceuticals, Inc. (Cambridge, MA), for approximately $8.8 billion through a cash tender offer of $25.00 per share. 2008-04-11T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/152008/509663null HTML http://biopharminternational.findpharma.com/biopharm/News/FDA-Issues-Guidance-Defining-Key-Terms-in-Pharmaco/ArticleStandard/Article/detail/509125?ref=25 In its effort to ensure that consistent definitions of terminology are being applied by all constituents of the ICH, the FDA has released a new guidance, E15, containing definitions of key terms in the discipline of pharmacogenomics and pharmacogenetics. 2008-04-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/152008/509125null HTML http://biopharminternational.findpharma.com/biopharm/News/CSL-Licenses-Novozymesrsquo-Albumin-Fusion-Technol/ArticleStandard/Article/detail/509038?ref=25 Novozymes (Bagsvaerd, Denmark) has signed an exclusive worldwide licensing agreement for its albumin fusion technology, albufuse, with CSL Behring (King of Prussia, PA). 2008-04-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/152008/509038null HTML http://biopharminternational.findpharma.com/biopharm/News/Sinovac-Receives-SFDA-Approval-for-H5N1-Vaccine/ArticleStandard/Article/detail/509032?ref=25 Sinovac Biotech Ltd. (Beijing, China) has announced that Panflu, its pandemic influenza H5N1 whole viron inactivated vaccine, has been granted a production license by the China State Food and Drug Administration (SFDA). 2008-04-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/152008/509032null HTML http://biopharminternational.findpharma.com/biopharm/News/Emerson-to-Automate-New-Plant-for-First-MAb-Drugs-/ArticleStandard/Article/detail/509025?ref=25 Emerson Process Management (St. Louis, MO) has been chosen to automate the first Chinese plant to produce monoclonal antibody drugs. 2008-04-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/152008/509025null HTML http://biopharminternational.findpharma.com/biopharm/News/Three-Companies-Recall-Heparin-Products-Because-of/ArticleStandard/Article/detail/509028?ref=25 American Health Packaging (AHP, Valley Forge, PA), B. Braun Medical Inc. (Irvine, CA), and Covidien (Mansfield, MA), have all announced voluntary recalls of heparin products after being notified by their supplier, Scientific Protein Laboratories LLC (SPL, Waunakee, WI), of a nationwide recall of heparin sodium USP active pharmaceutical ingredient (API) because of a heparin-like contaminant. 2008-04-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/152008/509028null HTML http://biopharminternational.findpharma.com/biopharm/News/FDA-Approves-New-GlaxoSmithKline-Vaccine-Against-R/ArticleStandard/Article/detail/509035?ref=25 The US FDA announced on April 4, 2008, the approval of Rotarix, the second oral US licensed vaccine for the prevention of rotavirus, an infection that causes gastroenteritis (vomiting and diarrhea) in infants and children. 2008-04-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/152008/509035null HTML http://biopharminternational.findpharma.com/biopharm/News/Hematech-Licenses-BAC-Ligand-for-Production-of-IgG/ArticleStandard/Article/detail/509040?ref=25 BAC BV, the Bio Affinity Company (Naarden, The Netherlands), has entered into a license and supply agreement with Hematech, Inc. (Sioux Falls, SD), a subsidiary of Kirin Pharma, that specializes in the production of human antibodies in transgenic cows. 2008-04-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/152008/509040null HTML http://biopharminternational.findpharma.com/biopharm/Miriam-Monge-Joins-BioPharm-Services/ArticleStandard/Article/detail/509046?ref=25 BioPharm Services (BPS, Chesham, UK) has appointed Miriam Monge vice president of Marketing and Disposables Systems Implementation. 2008-04-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/152008/509046null HTML http://biopharminternational.findpharma.com/biopharm/Shobha-Parthasarathi-Joins-NC-Biotech-Center-as-Te/ArticleStandard/Article/detail/509045?ref=25 Shobha Parthasarathi, PhD, has joined the North Carolina Biotechnology Center (Research Triangle Park, NC) as technology development director in the Business and Technology Development unit. 2008-04-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/152008/509045null HTML http://biopharminternational.findpharma.com/biopharm/News/PharmAthene-Acquires-Biodefence-Vaccines-from-Avec/ArticleStandard/Article/detail/509034?ref=25 PharmAthene, Inc., (Annapolis, MD), has completed its acquisition of Avecia’s (Manchester, UK) biodefense vaccines business. 2008-04-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/152008/509034null HTML http://biopharminternational.findpharma.com/biopharm/Vincent-J-Milano-Appointed-President-and-CEO-of-Vi/ArticleStandard/Article/detail/509044?ref=25 Vincent J. Milano has succeeded Michel de Rosen as president and chief executive officer of ViroPharma Incorporated (Exton, PA) and has been elected to its board of directors, effective March 31, 2008. 2008-04-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/152008/509044null HTML http://biopharminternational.findpharma.com/biopharm/Darren-Head-Named-CEO-of-Cytovance/ArticleStandard/Article/detail/509042?ref=25 Darren Head has been named chief executive officer of Cytovance (Oklahoma City, OK). Head comes to Cytovance from Atlanta-based Immucor where he served as vice-president of worldwide operations, overseeing the manufacturing of biological products in the US, Europe, and Canada. 2008-04-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/152008/509042null HTML http://biopharminternational.findpharma.com/biopharm/News/Schering-Plough-to-Cut-5500-Jobs/ArticleStandard/Article/detail/509030?ref=25 In what CEO and Chairman Fred Hassan is calling “tough actions that are needed to respond to a tough situation,” Schering-Plough (Kenilworth, NJ) has announced plans to eliminate 5,500 jobs (10% of its workforce). 2008-04-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/152008/509030null HTML http://biopharminternational.findpharma.com/biopharm/GTC-and-PharmAthene-Enter-Agreement-for-Nerve-Agen/ArticleStandard/Article/detail/509041?ref=25 GTC Biotherapeutics, Inc. (GTC, Framingham, MA) has entered into an extended agreement with PharmAthene, Inc. (Annapolis, MD) under which GTC will provide continuing process development and clinical supply manufacturing services for PharmAthene’s Protexia program. 2008-04-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/152008/509041null HTML http://biopharminternational.findpharma.com/biopharm/Outsourcing/Outsourcing-Laboratory-WorkmdashEstablishing-the-N/ArticleStandard/Article/detail/507455?ref=25 The outsourced service provider should be considered an extension of your own laboratory. 2008-04-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/142008/507455null XML http://biopharminternational.findpharma.com/biopharm/Outsourcing/Working-with-a-Contract-Manufacturer-Key-Considera/ArticleStandard/Article/detail/507452?ref=25 After a strategic evaluation of what activities to outsource, sponsor companies should follow key guidelines for selecting and auditing a provider and preparing quality agreements. 2008-04-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/142008/507452null XML http://biopharminternational.findpharma.com/biopharm/Outsourcing/Biopharmaceutical-Contract-Manufacturing-Contracto/ArticleStandard/Article/detail/507454?ref=25 When a biopharmaceutical company pursues an outsourcing strategy, the choice of a contractor is a critical and strategic decision. 2008-04-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/142008/507454null XML http://biopharminternational.findpharma.com/biopharm/Outsourcing/How-to-Conduct-an-Audit-of-an-Outsourcing-Provider/ArticleStandard/Article/detail/507456?ref=25 There are several considerations to keep in mind when auditing an outsourcing provider. 2008-04-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/142008/507456null XML http://biopharminternational.findpharma.com/biopharm/Outsourcing/Devising-an-International-Clinical-Trial-Distribut/ArticleStandard/Article/detail/509925?ref=25 A decision-criteria matrix and cost models helped pinpoint the best distribution approach for the short- and long-term. 2008-04-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/162008/509925null XML http://biopharminternational.findpharma.com/biopharm/Upstream+Processing/Leveraging-Fermentation-Heat-Transfer-Data-to-Bett/ArticleStandard/Article/detail/507474?ref=25 A simple method to leverage fermentation heat transfer data. 2008-04-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/142008/507474/0408_Berge_Fermenter_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Disposables+Advisor/Disposable-Bioreactors-The-Next-Generation/ArticleStandard/Article/detail/507470?ref=25 Disposable technologies that mimic the conventional stainless-steel bioreactor will be most readily adopted 2008-04-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/142008/507470null XML http://biopharminternational.findpharma.com/biopharm/Final+Word/Pharmaceutical-Quality-Success-Its-All-About-Manag/ArticleStandard/Article/detail/507486?ref=25 Engaging executive leadership in the quality process is the key to compliance success. 2008-04-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/142008/507486null XML http://biopharminternational.findpharma.com/biopharm/GMPs%2FValidation/FDAs-Inspection-Program-Under-Scrutiny/ArticleStandard/Article/detail/507463?ref=25 The heparin safety crisis puts a spotlight on manufacturing processes and regulatory oversight. 2008-04-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/142008/507463null XML http://biopharminternational.findpharma.com/biopharm/Business/Biopharmaceuticals-in-India-Evolving-from-Generics/ArticleStandard/Article/detail/507484?ref=25 The new patent regime is challenging the Indian biopharm industry to transition from generics to novel products. 2008-04-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/142008/507484/0408_Rashmi_India_2_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/From+the+Editor/What-We-Dont-Know-May-In-Fact-Hurt-Us/ArticleStandard/Article/detail/507459?ref=25 Now is a good time for companies to know their suppliers well. 2008-04-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/142008/507459null XML http://biopharminternational.findpharma.com/biopharm/Legal+Briefs/Trends-in-Convertible-Note-Financing-for-Biotechs/ArticleStandard/Article/detail/507473?ref=25 As more biotechs turn to convertible note financing instead of traditional venture capital, they need to be aware of investors' demands. 2008-04-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/142008/507473null XML http://biopharminternational.findpharma.com/biopharm/Perspectives+on+Outsourcing/Getting-the-Results-You-Expect-from-Consultants/ArticleStandard/Article/detail/507468?ref=25 There are several steps that you can take to ensure that you get the greatest benefit from consultants. 2008-04-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/142008/507468null XML http://biopharminternational.findpharma.com/biopharm/Business/Book-Review-Biopharmaceutical-Products-in-the-US-a/ArticleStandard/Article/detail/509926?ref=25 The book is a useful, comprehensive, and truly an excellent reference source of biopharmaceutical information. 2008-04-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/162008/509926null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Filter-Clogging-Issues-in-Sterile-Filtration/ArticleStandard/Article/detail/507480?ref=25 A case study investigated the root cause of failures in sterile filtration by evaluating the effects and interactions of four operating parameters. 2008-04-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/142008/507480/0408_Rathore_Sterile_Filter_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/India+Today/Understanding-Indias-New-Patent-Laws/ArticleStandard/Article/detail/507465?ref=25 Did the 2005 Patents Act engender a Western intellectual property rights culture in the country? 2008-04-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/142008/507465null XML http://biopharminternational.findpharma.com/biopharm/News/Heparin-Contaminant-Identified-by-FDA/ArticleStandard/Article/detail/504149?ref=25 The FDA has identified the "heparin-like" contaminant in the API of Baxter's recalled heparin products to be over-sulfated chondroitin sulfate, a commonly available, cheap chemical compound. 2008-03-19T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/122008/504149null HTML http://biopharminternational.findpharma.com/biopharm/News/FDA-Issues-Border-Alert-for-All-Heparin-Products/ArticleStandard/Article/detail/503221?ref=25 The FDA is putting into effect a border alert for all heparin products manufactured by the Changzhou SPL plant, Baxter's supplier of heparin API. This alert would stop all heparin products produced by Changzhou SPL that are slated for entry into the US now and in the future. 2008-03-14T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/112008/503221null HTML http://biopharminternational.findpharma.com/biopharm/Entirely-New-Flu-Vaccine-Needed-Next-Year-Says-WHO/ArticleStandard/Article/detail/502434?ref=25 According to a report released by the US Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO), the three most common types of influenza strains have changed in such a way that they are now showing signs of resistance to the Tamiflu and Relenza vaccines 2008-03-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/112008/502434null HTML http://biopharminternational.findpharma.com/biopharm/Gary-Swan-Appointed-VP-of-Operations-at-Laureate-P/ArticleStandard/Article/detail/502444?ref=25 Laureate Pharma, Inc. (Princeton, NJ), has appointed Gary Swan vice president of operations. 2008-03-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/112008/502444null HTML http://biopharminternational.findpharma.com/biopharm/Office-of-Surveillance-and-Epidemiology-Reorganiza/ArticleStandard/Article/detail/502446?ref=25 Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, has announced that the reorganization of the Office of Surveillance and Epidemiology (OSE) has been completed. 2008-03-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/112008/502446null HTML http://biopharminternational.findpharma.com/biopharm/News/CDER-Gains-Woodcock-as-Permanent-Chief/ArticleStandard/Article/detail/502425?ref=25 When CDER director Steven Galson left last year, Janet Woodcock shifted back as temporary chief. And now, after a long search for a replacement, she has decided to take on the job herself. 2008-03-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/112008/502425null HTML http://biopharminternational.findpharma.com/biopharm/News/Future-Technology-Needs-for-Biomanufacturing-Speci/ArticleStandard/Article/detail/502426?ref=25 “We need to improve our ability to measure protein variants in real time and understand how to correlate to biological significance,” commented Duncan Low, PhD, scientific executive director at Amgen, in a January 28 presentation at the IFPAC 2008 meeting in Baltimore, Maryland. 2008-03-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/112008/502426null HTML http://biopharminternational.findpharma.com/biopharm/FDA-Names-Woodcock-Permanent-Director-of-CDER/ArticleStandard/Article/detail/502441?ref=25 On March 10, 2008, US Food and Drug Administration Commissioner Andrew von Eschenbach, MD, announced that Janet Woodcock, MD, has been appointed director of the agency's Center for Drug Evaluation and Research (CDER), following a national search. 2008-03-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/112008/502441null HTML http://biopharminternational.findpharma.com/biopharm/News/Novozymes-and-Upperton-Collaborate-on-Nanoparticle/ArticleStandard/Article/detail/502428?ref=25 Novozymes (Bagsvaerd, Denmark) will collaborate with Upperton Limited (Nottingham, UK), a company specializing in novel nanoparticle-based drug delivery systems. 2008-03-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/112008/502428null HTML http://biopharminternational.findpharma.com/biopharm/News/PDL-BioPharma-Takes-Itself-off-the-Market-and-Rest/ArticleStandard/Article/detail/502429?ref=25 PDL BioPharma, Inc. (Redwood City, CA) announced on March 4, 2008 that it will no longer actively pursue the sale of the company or of its biotechnology discovery and development assets. 2008-03-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/112008/502429null HTML http://biopharminternational.findpharma.com/biopharm/Pfizer-to-Access-Novel-Technology-Platform-with-Ac/ArticleStandard/Article/detail/502436?ref=25 Pfizer, Inc. (New York, NY) will acquire Serenex, Inc. (Durham, NC), a biotechnology company with a Phase 1 clinical candidate and an extensive compound library that targets Heat Shock Protein 90 (Hsp90), a target in the fight against cancer. 2008-03-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/112008/502436null HTML http://biopharminternational.findpharma.com/biopharm/News/Small-Biotech-Companies-Handle-Most-Regulatory-Fil/ArticleStandard/Article/detail/502430?ref=25 Most small and mid-size biopharmaceutical companies still handle most regulatory filings on paper, recent industry research shows, despite the fact that larger companies and regulators are rapidly shifting toward an electronic environment. 2008-03-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/112008/502430null HTML http://biopharminternational.findpharma.com/biopharm/Nasal-Vaccine-for-Smallpox-Confers-High-Levels-of-/ArticleStandard/Article/detail/502432?ref=25 A recent study conducted by scientists at NanoBio Corporation (Ann Arbor, MI) and the University of Michigan (Ann Arbor, MI) has demonstrated that their nasally delivered vaccinia vaccine can protect animals against 77 times the potentially lethal dose of smallpox, and without the safety risks of current vaccines for smallpox. 2008-03-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/112008/502432null HTML http://biopharminternational.findpharma.com/biopharm/News/ESBATechs-Antibody-Fragments-Penetrate-the-Eye-fro/ArticleStandard/Article/detail/502427?ref=25 ESBATech AG (Zurich, Switzerland) has achieved high concentrations of its antibody fragments in all segments of the eye with topical delivery via eye drops. 2008-03-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/112008/502427null HTML http://biopharminternational.findpharma.com/biopharm/Genentech-Gains-Expanded-Access-to-Sangamos-Protei/ArticleStandard/Article/detail/502439?ref=25 Sangamo BioSciences, Inc. (Richmond, CA) has entered into a second research and license agreement with Genentech, Inc. (South San Francisco, CA), expanding on the original agreement to include additional targets for potential improvement of production cell lines using Sangamo's proprietary zinc finger DNA-binding protein nuclease (ZFN) technology 2008-03-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/112008/502439null HTML http://biopharminternational.findpharma.com/biopharm/Saint-Gobain-Acquires-Disposable-Plastics-Manufact/ArticleStandard/Article/detail/502440?ref=25 Saint-Gobain Performance Plastics Corporation (Aurora, OH) has acquired the assets of J & J Scientific Products, Inc. (Tampa, FL), a manufacturer of disposable plastic products for the biopharmaceutical market. 2008-03-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/112008/502440null HTML http://biopharminternational.findpharma.com/biopharm/Franz-B-Humer-Steps-Down-as-CEO-of-Roche/ArticleStandard/Article/detail/502442?ref=25 Franz B. Humer has stepped down as chief executive officer (CEO) of the Roche Group (Basel, Switzerland), after holding that title for 10 years. 2008-03-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/112008/502442null HTML http://biopharminternational.findpharma.com/biopharm/GSK-Licenses-Interleukin-6-Antibody-from-EUSA/ArticleStandard/Article/detail/502437?ref=25 EUSA Pharma (Oxford, UK) has out-licensed the exclusive worldwide rights to its preclinical-stage human anti-interleukin-6 antibody to GlaxoSmithKline (GSK, Middlesex, UK) for consideration of up to $44 million 2008-03-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/112008/502437null HTML http://biopharminternational.findpharma.com/biopharm/Sanofi-Pasteur-Mounts-Emergency-Response-to-Yellow/ArticleStandard/Article/detail/502433?ref=25 Sanofi Pasteur (Lyon, France) has shipped six million doses of its Stamaril yellow fever vaccine in response to the to the yellow fever epidemic in Latin America. 2008-03-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/112008/502433null HTML http://biopharminternational.findpharma.com/biopharm/News/US-Pharmacopeia-Opens-New-Headquarters/ArticleStandard/Article/detail/502431?ref=25 The US Pharmacopeia (USP) held an official grand opening celebration on March 3, 2008, for its new global headquarters in Rockville, MD. 2008-03-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/112008/502431null HTML http://biopharminternational.findpharma.com/biopharm/News/Biogenerics-Conference-Addresses-Scientific-and-Re/ArticleStandard/Article/detail/502423?ref=25 When considering how follow-on biologics will be compared to innovator products, Emily Shacter has a favorite question 2008-03-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/112008/502423null HTML http://biopharminternational.findpharma.com/biopharm/News/FDA-Approves-Regenerons-Acralyst/ArticleStandard/Article/detail/500935?ref=25 The US FDA has approved Arcalyst (rilonacept, an interleukin-1 blocker) for the long-term treatment of two cryopyrin-associated periodic syndrome (CAPS) disorders. 2008-03-06T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/102008/500935null HTML http://biopharminternational.findpharma.com/biopharm/News/German-Ministry-of-Health-Recalls-Heparin-Products/ArticleStandard/Article/detail/501003?ref=25 German authorities have received a cluster of reports of adverse reactions to heparin products that are similar to the reactions previously reported to the US FDA, causing the German authorities to initiate a recall of heparin products. 2008-03-06T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/102008/501003null HTML http://biopharminternational.findpharma.com/biopharm/News/FDA-Finds-Heparin-like-Contaminant-in-Heparin-API/ArticleStandard/Article/detail/500556?ref=25 The FDA has found what it is calling a "heparin-like" compound in the API of heparin that is not heparin. 2008-03-05T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/102008/500556null HTML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Economic-Drivers-and-Trade-Offs-in-Antibody-Purifi/ArticleStandard/Article/detail/499149?ref=25 The future of therapeutic MAbs lies in the development of economically feasible downstream processes. 2008-03-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/092008/499149null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Optimizing-the-Primary-Recovery-Step-in-Nonaffinit/ArticleStandard/Article/detail/499143?ref=25 An alternative approach to traditional Protein A schemes is comparable in overall efficiency, product recovery, and quality. 2008-03-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/092008/499143null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Solutions-for-Purification-of-Fc-fusion-Proteins/ArticleStandard/Article/detail/499145?ref=25 When platform processes are applied to fusion molecules, innovation and flexibility are needed. 2008-03-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/092008/499145null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Process-Scale-Precipitation-of-Impurities-in-Mamma/ArticleStandard/Article/detail/499144?ref=25 If certain engineering challenges can be addressed, precipitation may prove to be a valuable tool for antibody purification. 2008-03-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/092008/499144null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Purification-of-IgM-Monoclonal-Antibodies/ArticleStandard/Article/detail/499148?ref=25 Manufacturing challenges surround the use of IgM monoclonal antibodies, but these can be overcome with current technology. 2008-03-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/092008/499148null XML http://biopharminternational.findpharma.com/biopharm/From+the+Editor/What-the-Heparin-Crisis-Should-Tell-Us/ArticleStandard/Article/detail/499130?ref=25 The cause of the heparin crisis is still unknown. We do know, however, that the FDA is severely underfunded. 2008-03-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/092008/499130null XML http://biopharminternational.findpharma.com/biopharm/India+Today/Biologics-Regulation-in-India/ArticleStandard/Article/detail/499133?ref=25 India is restructuring its regulation of biopharmaceuticals to help the country's industry compete internationally. 2008-03-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/092008/499133null XML http://biopharminternational.findpharma.com/biopharm/GMPs%2FValidation/FDA-Encourages-Quality-by-Design-Initiatives/ArticleStandard/Article/detail/499131?ref=25 More informed submissions may lead to regulatory flexibility for postapproval changes. 2008-03-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/092008/499131null XML http://biopharminternational.findpharma.com/biopharm/Outsourcing/Offshore-Opportunity-on-the-Rise/ArticleStandard/Article/detail/499132?ref=25 The supply base for preclinical and clinical development services continues to expand in China. 2008-03-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/092008/499132null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Evaluation-of-Dendritic-Cell-Products-Generated-fo/ArticleStandard/Article/detail/499137?ref=25 Emerging therapies pose challenges for standardizing QC. 2008-03-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/092008/499137/Whiteside_Dendritic_Cell_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Burrill+on+Biotech/What-Lies-Ahead-for-Biotech-in-2008/ArticleStandard/Article/detail/499134?ref=25 Despite the rising fears about a slowing economy, the biotech industry will continue to maintain its momentum this year. 2008-03-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/092008/499134null XML http://biopharminternational.findpharma.com/biopharm/Compliance+Notes/How-to-Ensure-Smooth-Technology-Transfer/ArticleStandard/Article/detail/499135?ref=25 A comprehensive process and analytical transfer package can speed up your product's time to market and save costs. 2008-03-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/092008/499135null XML http://biopharminternational.findpharma.com/biopharm/Emerging+Biotechs/Creating-Affordable-Vaccines-for-India/ArticleStandard/Article/detail/499136?ref=25 How an electronics engineer led the first Indian company to carry out indigenous development of a recombinant vaccine. 2008-03-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/092008/499136null XML http://biopharminternational.findpharma.com/biopharm/Business/How-to-Avoid-Becoming-a-Biotech-Zombie-Part-3/ArticleStandard/Article/detail/499139?ref=25 Two business models that companies can follow to map their strategy from concept to implementation. 2008-03-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/092008/499139/Villafranca_biopharm_zombie_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/GMPs%2FValidation/Cleaning-Validation-for-Biopharm-Manufacturing-at-/ArticleStandard/Article/detail/499138?ref=25 Need a standard to follow? Just ask, What would Genentech do? 2008-03-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/092008/499138/mollah_Cleaning_validation_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Final+Word/Can-the-FDA-Live-up-to-its-Promise-of-a-Risk-Based/ArticleStandard/Article/detail/499129?ref=25 The expanding globalization of the industry poses a challenge for international enforcement. 2008-03-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/092008/499129null XML http://biopharminternational.findpharma.com/biopharm/Whitepapers/Fermentation-Process-Monitoring-Dissolved-Carbon-D/ArticleStandard/Article/detail/492381?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. 2008-03-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/082008/492381null REMOTE http://biopharminternational.findpharma.com/biopharm/News/Baxter-Expands-Heparin-Recall-FDA-Issues-483-to-Ch/ArticleStandard/Article/detail/499150?ref=25 Following the partial recall initiated on January 25, 2008, Baxter Healthcare has expanded its recall of heparin. 2008-02-29T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/092008/499150null HTML http://biopharminternational.findpharma.com/biopharm/News/Letters-Sent-to-Baxter-and-FDA-Request-Answers-on-/ArticleStandard/Article/detail/498785?ref=25 On February 21, 2008, a congressional committee sent letters to Baxter Healthcare and the FDA seeking information related to the recent heparin recall. 2008-02-28T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/092008/498785null HTML http://biopharminternational.findpharma.com/biopharm/News/Genentech-Receives-Notice-of-Cabilly-Patent-Reject/ArticleStandard/Article/detail/498901?ref=25 Genentech has been notified that their Cabilly patent claim has been rejected by the US Patent and Trademark Office. 2008-02-28T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/092008/498901null HTML http://biopharminternational.findpharma.com/biopharm/News/Two-Biotech-Drugs-Approved-for-New-Indications/ArticleStandard/Article/detail/498903?ref=25 On February 22, 2008, the FDA approved two biotech drugs, Avastin (bevacizumab) and HUMIRA (Adalimumab), for additional indications. 2008-02-28T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/092008/498903null HTML