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. 2009-07-03T22:06:02Z http://biopharminternational.findpharma.com/biopharm/News/Genzyme-Recalls-Fabrazyme-5-mg/ArticleStandard/Article/detail/607536?ref=25 Genzyme has voluntarily recalled all remaining stock of Fabrazyme 5 mg (agalsidase beta), with batch numbers A8049H04 and A8060H01. 2009-06-30T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/272009/607536null HTML http://biopharminternational.findpharma.com/biopharm/News/OctoPlus-Opens-New-GMP-Manufacturing-Facility/ArticleStandard/Article/detail/606148?ref=25 OctoPlus has started production in its new manufacturing facility in Leiden. 2009-06-24T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/262009/606148null HTML http://biopharminternational.findpharma.com/biopharm/Whitepapers/Purification-of-a-Monoclonal-Antibody-Using-a-Comb/ArticleStandard/Article/detail/608023?ref=25 Antibody-based drugs represent a growing segment of the pharmaceutical industry and one of the most promising classes of therapeutic drugs. 2009-06-23T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/272009/608023null REMOTE http://biopharminternational.findpharma.com/biopharm/Whitepapers/Purification-of-Murine-IgG1-Using-UNOsphere-S-and-/ArticleStandard/Article/detail/608038?ref=25 Immunoglobulins (IgGs) from a variety of sources have been purified using the conventional process composed of a protein A chromatography step along with ion exchange chromatography and hydrophobic interaction chromatography steps (Jiskoot et al. 1989, Godfrey et al. 1993, Shadle et al. 1995, Ford et al. 2001). 2009-06-23T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/272009/608038null REMOTE http://biopharminternational.findpharma.com/biopharm/Podcast--keith-Webber/ArticleStandard/Article/detail/605513?ref=25 2009-06-22T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/262009/605513null HTML http://biopharminternational.findpharma.com/biopharm/News/Vetter-Installs-Six-Automatic-Packaging-Lines-at-i/ArticleStandard/Article/detail/605103?ref=25 Vetter Pharma International (Ravensburg, Germany) has completed the installation of six automatic packaging lines at Vetter Secondary Packaging (VSP), the company?s new packaging services facility. 2009-06-19T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/252009/605103null HTML http://biopharminternational.findpharma.com/biopharm/Analytical-Strategies-for-Monitoring-Residual-Impu/ArticleStandard/Article/detail/604780?ref=25 Analytical Strategies for Monitoring Residual Impurities Encountered In Bioprocessing 2009-06-18T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/252009/604780null PDF http://biopharminternational.findpharma.com/biopharm/News/Three-Shared-Audit-Models-Tested-at-Rx-360-Consort/ArticleStandard/Article/detail/604363?ref=25 The newly formed Rx-360 consortium had an impressive turnout of over 125 people at its launch meeting in Washington, DC, on June 5. 2009-06-17T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/252009/604363null HTML http://biopharminternational.findpharma.com/biopharm/News/Genzyme-Detects-Virus-Contamination-of-Bioreactor-/ArticleStandard/Article/detail/604361?ref=25 Genzyme Corporation has halted production at its manufacturing plant in Allston Landing, MA, because it has detected a virus that impairs cell growth in one of the six bioreactors there. 2009-06-17T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/252009/604361null HTML http://biopharminternational.findpharma.com/biopharm/Podcast--Jim-Greenwood/ArticleStandard/Article/detail/603783?ref=25 2009-06-16T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/252009/603783null HTML http://biopharminternational.findpharma.com/biopharm/News/14-Years-of-Market-Exclusivity-Unnecessary-says-FT/ArticleStandard/Article/detail/603355?ref=25 A new report by FTC, entitled ?Follow-on Biologic Drug Competition,? examines whether the price of biologics is likely to be reduced by competition from FOBs. 2009-06-16T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242009/603355null HTML http://biopharminternational.findpharma.com/biopharm/Purification-of-Murine-IgG1-Using-UNOsphere-S-and-/ArticleStandard/Article/detail/603751?ref=25 Purification of Murine IgG1 Using UNOsphere? S and CHT? Ceramic Hydroxyapatite Chromatography-BioRad Whitepaper 2009-06-15T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/252009/603751null PDF http://biopharminternational.findpharma.com/biopharm/Purification-of-a-Monoclonal-Antibody-Using-a-Comb/ArticleStandard/Article/detail/603760?ref=25 Purification of a Monoclonal Antibody Using a Combination of UNOsphere? Rapid S and UNOsphere Q Media Ion Exchange Chromatography After Protein A Capture-BioRad Whitepaper 2009-06-15T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/252009/603760null PDF http://biopharminternational.findpharma.com/biopharm/Monoclonal-Antibody-Purification-Using-UNOsphere-S/ArticleStandard/Article/detail/603758?ref=25 Monoclonal Antibody Purification Using UNOsphere SUPrA Media-BioRad Whitepaper 2009-06-15T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/252009/603758null PDF http://biopharminternational.findpharma.com/biopharm/Packing-and-Slurry-in-Place-Prodeduures-for-CHT-Ce/ArticleStandard/Article/detail/603756?ref=25 Packing and Slurry-in-Place Prodeduures for CHT Cermaic Hydroxyapatite Using a BioRad InPlace Process-Scale Chromatography Column-BioRad Whitepaper 2009-06-15T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/252009/603756null PDF http://biopharminternational.findpharma.com/biopharm/News/Louisiana-Biotech-Firm-Explores-the-Potential-of-A/ArticleStandard/Article/detail/602899?ref=25 Nupotential, a small Louisiana biotechnology firm, believes it may have an answer to the ethical concerns and technological challenges involved in turning stem cells into medical therapies. 2009-06-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242009/602899null HTML http://biopharminternational.findpharma.com/biopharm/News/Emisphere-Technologies-and-AAIPharma-to-Expand-Use/ArticleStandard/Article/detail/602931?ref=25 Emisphere Technologies, Inc. (Cedar Knolls, NJ), a biopharmaceutical company that focuses on delivery of therapeutic molecules using its Eligen Technology, and AAIPharma, Inc. (Wilmington, NC), have formed a strategic alliance intended to expand the application of Emisphere' s Eligen Technology and AAIPharma's drug development services. 2009-06-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242009/602931null HTML http://biopharminternational.findpharma.com/biopharm/News/Emerson-Wins-Lonza-Automation-Contract-for-Biophar/ArticleStandard/Article/detail/602923?ref=25 Emerson Process Management (Austin, TX) has been selected by Lonza Group, Ltd. (Basel, Switzerland) to provide engineering and design services, and digital automation architecture and control technologies for a new Lonza biopharmaceutical plant in Singapore. 2009-06-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242009/602923null HTML http://biopharminternational.findpharma.com/biopharm/News/Europe-Australia-and-US-Enter-Regulatory-Informati/ArticleStandard/Article/detail/602890?ref=25 The European Directorate for Quality of Medicines & HealthCare (EDQM) has established bilateral confidentiality agreements with the US Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration (TGA), respectively, to share non-public information regarding inspections of active pharmaceutical ingredients (API) and excipients manufacturers. 2009-06-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242009/602890null HTML http://biopharminternational.findpharma.com/biopharm/News/SAFC-Pharmas-St-Louis-HPAPI-Conjugates-Facility-Re/ArticleStandard/Article/detail/602913?ref=25 SAFC Pharma (St. Louis, MO) has received certification by SafeBridge Consultants, Inc., for the safe handling of potent drug substances of its highly potent active pharmaceutical ingredient (HPAPI) conjugation suite, located in St. Louis, MO. 2009-06-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242009/602913null HTML http://biopharminternational.findpharma.com/biopharm/News/AFFiRiS-AGs-Atherosclerosis-Vaccine-Development-Re/ArticleStandard/Article/detail/602917?ref=25 The atherosclerosis vaccine development program by AFFiRiS AG (Vienna, Austria) is receiving financial support from the EU?s EuroTrans-Bio call. 2009-06-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242009/602917null HTML http://biopharminternational.findpharma.com/biopharm/News/HHS-Awards-MedImmune-Contract-to-Manufacture-Live-/ArticleStandard/Article/detail/602916?ref=25 MedImmune (Gaithersburg, MD) has been awarded a US Department of Health and Human Services (HHS) contract to manufacture monovalent (single-strain) live attenuated influenza vaccine for Novel Influenza A (H1N1) to vaccinate priority populations identified by HHS in the National Strategy for Pandemic Influenza. An initial order of $90 million of vaccine has been placed, with the potential for additional orders. 2009-06-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242009/602916null HTML http://biopharminternational.findpharma.com/biopharm/News/BioPharm-Editor-in-Chief-Laura-Bush-Joins-Interphe/ArticleStandard/Article/detail/602892?ref=25 Laura Bush, editor in chief of BioPharm International, has joined the 2010 Interphex Conference Advisory Board. 2009-06-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242009/602892null HTML http://biopharminternational.findpharma.com/biopharm/News/ImmunoVaccine-Technologies-Partners-with-FIT-Biote/ArticleStandard/Article/detail/602918?ref=25 ImmunoVaccine Technologies, Inc. (IVT, Halifax, Nova Scotia), a vaccine development company, has formed a research partnership with FIT Biotech (Tampere, Finland), a clinical stage company that develops DNA vaccines. 2009-06-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242009/602918null HTML http://biopharminternational.findpharma.com/biopharm/News/SAFC-and-Cherokee-Pharmaceuticals-Pool-Expertise-a/ArticleStandard/Article/detail/602933?ref=25 SAFC (St. Louis, MO), a member of the Sigma-Aldrich group, and Cherokee Pharmaceuticals (Riverside, PA), have formed an exclusive strategic partnership that encompasses the sourcing, analytical testing, warehousing, packaging, and distribution of large-scale raw materials for pharmaceutical manufacturing meeting cGMP quality standards. 2009-06-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242009/602933null HTML http://biopharminternational.findpharma.com/biopharm/News/FDA-Makes-Mixed-Progress-on-IT-Improvement/ArticleStandard/Article/detail/602889?ref=25 The US Food and Drug Administration has made "mixed progress" in information technology (IT) modernization, according to findings from the Government Accountability Office (GAO). 2009-06-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242009/602889null HTML http://biopharminternational.findpharma.com/biopharm/AAPS-Biotech-Exhibitor-Showcase/ArticleStandard/Article/detail/602888?ref=25 2009-06-11T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242009/602888null HTML http://biopharminternational.findpharma.com/biopharm/Scarab-Genomics/ArticleStandard/Article/detail/602424?ref=25 2009-06-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242009/602424null REMOTE http://biopharminternational.findpharma.com/biopharm/Althea/ArticleStandard/Article/detail/602425?ref=25 2009-06-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242009/602425null REMOTE http://biopharminternational.findpharma.com/biopharm/Applikon/ArticleStandard/Article/detail/602421?ref=25 2009-06-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242009/602421null REMOTE http://biopharminternational.findpharma.com/biopharm/Mallinckrodt-Baker/ArticleStandard/Article/detail/602437?ref=25 2009-06-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242009/602437null REMOTE http://biopharminternational.findpharma.com/biopharm/New-Brunswick-Scientific/ArticleStandard/Article/detail/602415?ref=25 2009-06-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242009/602415null REMOTE http://biopharminternational.findpharma.com/biopharm/Innovatis/ArticleStandard/Article/detail/602422?ref=25 2009-06-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242009/602422null REMOTE http://biopharminternational.findpharma.com/biopharm/Millipore/ArticleStandard/Article/detail/602423?ref=25 2009-06-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242009/602423null REMOTE http://biopharminternational.findpharma.com/biopharm/Bioengineering-AG/ArticleStandard/Article/detail/602436?ref=25 2009-06-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242009/602436null REMOTE http://biopharminternational.findpharma.com/biopharm/Millipore-Celliance/ArticleStandard/Article/detail/602430?ref=25 2009-06-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242009/602430null REMOTE http://biopharminternational.findpharma.com/biopharm/Pfenex/ArticleStandard/Article/detail/602417?ref=25 2009-06-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242009/602417null REMOTE http://biopharminternational.findpharma.com/biopharm/Lonza/ArticleStandard/Article/detail/602418?ref=25 2009-06-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242009/602418null REMOTE http://biopharminternational.findpharma.com/biopharm/Glen-Mills/ArticleStandard/Article/detail/602432?ref=25 2009-06-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242009/602432null REMOTE http://biopharminternational.findpharma.com/biopharm/Grenier-Bio-One/ArticleStandard/Article/detail/602427?ref=25 2009-06-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242009/602427null REMOTE http://biopharminternational.findpharma.com/biopharm/Xcellerex/ArticleStandard/Article/detail/602438?ref=25 2009-06-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/242009/602438null REMOTE http://biopharminternational.findpharma.com/biopharm/News/Louisiana-Biotech-Firm-Explores-the-Potential-of-A/ArticleStandard/Article/detail/601973?ref=25 Nupotential, a small Louisiana biotechnology firm, believes it may have an answer to the ethical concerns and technological challenges involved in turning stem cells into medical therapies. 2009-06-05T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232009/601973null HTML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing+Articles/Using-Metabolic-Profiling-Technology-to-Advance-Ce/ArticleStandard/Article/detail/601190?ref=25 Through metabolomics, the metabolic underpinnings of cellular changes can be rapidly pinpointed, directing process development scientists to key areas for cell culture optimization. 2009-06-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232009/601190null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing+Articles/The-Impact-of-Cell-Culture-Medium-on-Cell-Line-and/ArticleStandard/Article/detail/601146?ref=25 ACF medium sped up cell-line development. 2009-06-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232009/601146/bp0609s_culture_medium_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing+Articles/Managing-Cell-Line-Instability-and-Its-Impact-Duri/ArticleStandard/Article/detail/601147?ref=25 By considering stability as part of the cell line selection and cell banking paradigm, we can ensure that instability problems are not observed during clinical or commercial manufacturing. 2009-06-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232009/601147null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing+Articles/Production-Strategies-for-Antibody-Fragment-Therap/ArticleStandard/Article/detail/601148?ref=25 Microbial systems such as E. Coli and yeasts are most effective for producing antibody fragments. 2009-06-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232009/601148/bp0609s_antibody_fragments_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Disposables+Advisor/User-Viewpoints-on-Disposables-Implementation/ArticleStandard/Article/detail/601411?ref=25 What end users think about single-use systems. 2009-06-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232009/601411null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing+Articles/Using-Fluorescence--Based-Sensing-to-Accelerate-Pr/ArticleStandard/Article/detail/601409?ref=25 A prove-free system monitors accurately at very small scale. 2009-06-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232009/601409/bp0609_fluorescence_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/From+the+Editor/The-Ups-and-Downs-of-the-FDA-Budget/ArticleStandard/Article/detail/601413?ref=25 Importing foreign drugs is not the best way to increase access to medicine. The risks are too high, and it burdens the over-stretched FDA unfairly. 2009-06-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232009/601413null XML http://biopharminternational.findpharma.com/biopharm/Business+Articles/Biological-Potency-Assays-are-Key-to-Assessing-Pro/ArticleStandard/Article/detail/601410?ref=25 Modern bioassays enable more accurate potency testing. 2009-06-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232009/601410null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing+Articles/Best-Practices-for-Formulation-and-Manufacturing-o/ArticleStandard/Article/detail/601406?ref=25 How to maintain product stability and prevent particulates. 2009-06-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232009/601406/bp0609_formulation_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Outsourcing+Articles/UK-Service-Providers-Look-to-the-New-World/ArticleStandard/Article/detail/601407?ref=25 UK-based CMOs seek opportunities in new markets. 2009-06-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232009/601407null XML http://biopharminternational.findpharma.com/biopharm/Regulatory+Compliance+Articles/Stiffer-Enforcement-at-the-FDA/ArticleStandard/Article/detail/601412?ref=25 Agency officials promise swift action against violators of drug safety and quality regulations. 2009-06-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232009/601412null XML http://biopharminternational.findpharma.com/biopharm/Manufacturing+Economics+Articles/On-the-Horizon-New-Expression-Systems-to-Become-Co/ArticleStandard/Article/detail/601408?ref=25 New expression systems compete for attention. 2009-06-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232009/601408null XML http://biopharminternational.findpharma.com/biopharm/News/New-Legislation-to-Boost-FDAs-Inspection-and-Enfor/ArticleStandard/Article/detail/597954?ref=25 On April 24, Senators Charles Grassley (R-IA) and Edward Kennedy (D-MA) introduced The Drug and Device Accountability Act of 2009, which would give the FDA more resources for conducting foreign drug plant inspections and the power to issue subpoenas. 2009-05-15T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/202009/597954null HTML http://biopharminternational.findpharma.com/biopharm/News/ImmunoVaccine-Technologies-to-Help-Strengthen-Cana/ArticleStandard/Article/detail/597961?ref=25 ImmunoVaccine Technologies, Inc. (IVT, Halifax, Nova Scotia), a vaccine development company, has signed a three-year research agreement with Defence Research and Development Canada (DRDC). 2009-05-15T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/202009/597961null HTML http://biopharminternational.findpharma.com/biopharm/Whitepapers/Lancaster-Labs-develops-extractables-database-for-/ArticleStandard/Article/detail/598056?ref=25 Extractable studies are performed to evaluate the potential of adulteration of drug products due to contact with packaging, delivery devices or components utilized during manufacturing. Non-volatile extractables are evaluated by performing liquid chromatography with mass spectrometric detection. Currently no commercial databases are available to assist with the identification of extracted compounds by this technique. Lancaster Laboratories has created a database of non-volatile compounds to assist with the identification of extracted compounds. 2009-05-15T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/202009/598056null REMOTE http://biopharminternational.findpharma.com/biopharm/News/Millipore-and-Microbix-to-Develop-a-Novel-Purifica/ArticleStandard/Article/detail/597966?ref=25 Millipore Corporation (Billerica, MA) and Microbix Biosystems, Inc. (Toronto, Canada), have formed a collaboration to develop a novel purification process for influenza virus vaccine manufacturing. 2009-05-13T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/202009/597966null HTML http://biopharminternational.findpharma.com/biopharm/News/FDA-Authorizes-Emergency-Use-of-Tamiflu-and-Relenz/ArticleStandard/Article/detail/597960?ref=25 In response to requests from the US Centers for Disease Control and Prevention (CDC), the US Food and Drug Administration has authorized the use of the antiviral drugs Tamiflu and Relenza beyond their approved indications in response to the outbreak of swine flu. 2009-05-13T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/202009/597960null HTML http://biopharminternational.findpharma.com/biopharm/News/FDA-Researchers-Contribute-Insights-into-Avian-Flu/ArticleStandard/Article/detail/597963?ref=25 An in-depth analysis of blood from patients recovering from the H5N1 avian influenza virus has provided important insights into how to combat the potentially lethal virus. 2009-05-13T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/202009/597963null HTML http://biopharminternational.findpharma.com/biopharm/News/Merck-Secures-Rights-to-Two-Novel-Monoclonal-Antib/ArticleStandard/Article/detail/597964?ref=25 Merck & Co., Inc. (Whitehouse Station, NJ), Medarex, Inc. (Princeton, NJ), and Massachusetts Biologic Laboratories (MBL, Jamaica Plain, MA) of the University of Massachusetts Medical School (UMMS) have signed an exclusive worldwide license agreement for CDA-1 and CDB-1. 2009-05-13T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/202009/597964null HTML http://biopharminternational.findpharma.com/biopharm/News/Manufacturing-Issues-Cause-Surfaxins-Fourth-Failur/ArticleStandard/Article/detail/597956?ref=25 In its latest setback, Discovery Labs (Warrington, PA) has failed to receive FDA approval for the fourth time for Surfaxin (lucinactant). 2009-05-13T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/202009/597956null HTML http://biopharminternational.findpharma.com/biopharm/News/New-Coalition-Aims-to-Improve-Pharmaceutical-Suppl/ArticleStandard/Article/detail/597952?ref=25 Members of the pharmaceutical and biotech industries have formed a new industry coalition, called "Rx-360," with the goal of improving supply chain safety. 2009-05-13T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/202009/597952null HTML http://biopharminternational.findpharma.com/biopharm/Whitepapers/In-Vivo-Spectroscopy-of-Human-Tissue-Skin-and-Cart/ArticleStandard/Article/detail/598057?ref=25 Mid-IR spectroscopy is a very useful technique for characterizing biological tissue. The combination of a sensitive ATR crystal with a flexible fiber-optic cable turns it into a truly non-invasive, in-situ method. 2009-05-13T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/202009/598057null REMOTE http://biopharminternational.findpharma.com/biopharm/News/Small-Vaccine-Company-Ready-to-Play-its-Part-in-Re/ArticleStandard/Article/detail/596504?ref=25 The current outbreak of the H1N1 influenza strain is exactly the kind of situation the vaccine company Novavax (Rockville, MD) has been preparing for over the last three years. 2009-05-04T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/192009/596504null HTML http://biopharminternational.findpharma.com/biopharm/BIO-2009-Product-Focus/ArticleStandard/Article/detail/596456?ref=25 2009-05-04T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/192009/596456null HTML http://biopharminternational.findpharma.com/biopharm/From+the+Editor/The-Least-of-Four-Evils/ArticleStandard/Article/detail/596021?ref=25 Avoiding healthcare reform is not the best option for the pharmaceutical industry. 2009-05-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182009/596021null XML http://biopharminternational.findpharma.com/biopharm/Manufacturing+Economics+Articles/Royalty-Interest-Investing-Addressing-the-Out-Lice/ArticleStandard/Article/detail/596025?ref=25 Several legal considerations are key to protect the buyer and seller in royalty interest transactions. 2009-05-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182009/596025null XML http://biopharminternational.findpharma.com/biopharm/Quality/QbD-Convincing-the-Skeptics/ArticleStandard/Article/detail/596027?ref=25 Without a rigorous discussion of the pros and cons of QbD, its tremendous benefits will be lost. 2009-05-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182009/596027null XML http://biopharminternational.findpharma.com/biopharm/Business+Articles/Efficient-Compliance-Without-Re-inventing-the-Whee/ArticleStandard/Article/detail/596028?ref=25 Why the industry needs to review its traditional approach to facility validation 2009-05-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182009/596028null XML http://biopharminternational.findpharma.com/biopharm/Manufacturing+Economics+Articles/Declining-Market-Demand-Intensifies-Competition/ArticleStandard/Article/detail/596024?ref=25 The current competitive environment is forcing service providers to evaluate their business models and focus on value and performance. 2009-05-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182009/596024null XML http://biopharminternational.findpharma.com/biopharm/Regulatory+Compliance+Articles/Comparative-Effectiveness-Research-to-Shape-Biotec/ArticleStandard/Article/detail/596022?ref=25 Authorities are pushing for CE; manufacturers prefer to focus on value. 2009-05-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182009/596022null XML http://biopharminternational.findpharma.com/biopharm/Outsourcing+Articles/Establishing-a-Successful-CROndashClient-Relations/ArticleStandard/Article/detail/596020?ref=25 It is essential to build and maintain a good working relationship between the client and contract research organization. 2009-05-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182009/596020null XML http://biopharminternational.findpharma.com/biopharm/Manufacturing+Economics+Articles/When-Less-is-More-Lean-Can-Help-Reduce-Costs-and-I/ArticleStandard/Article/detail/596029?ref=25 Use Lean techniques to improve manufacturing compliance 2009-05-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182009/596029null XML http://biopharminternational.findpharma.com/biopharm/Operations+Articles/Application-of-Overall-Equipment-Effectiveness-to-/ArticleStandard/Article/detail/596023?ref=25 How to optimize facility utilization and improve plant performance. 2009-05-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182009/596023null XML http://biopharminternational.findpharma.com/biopharm/Quality/Monitoring-of-Biopharmaceutical-Processes-Present-/ArticleStandard/Article/detail/596026?ref=25 This article reviews some of the commonly used approaches for process monitoring as well as the evolution of process monitoring in the Quality by Design (QbD) paradigm. 2009-05-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182009/596026null XML http://biopharminternational.findpharma.com/biopharm/News/Novozymes-Recombinant-Human-Albumins-Comply-with-N/ArticleStandard/Article/detail/596096?ref=25 A new excipient monograph standard for recombinant human albumin (HSA) became official in the United States Pharmacopeia-National Formulary (USP-NF) today, and Novozymes Biopharma (Nottingham, UK) says that its "Recombumin" and "Albucult" products are the first to comply with the new standard. 2009-05-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182009/596096null HTML http://biopharminternational.findpharma.com/biopharm/In-Vivo-Spectroscopy-of-Human-Tissue-Skin-and-Cart/ArticleStandard/Article/detail/597978?ref=25 In-Vivo Spectroscopy of Human Tissue: Skin and Cartilage-Remspec Whitepaper 2009-05-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/202009/597978null PDF http://biopharminternational.findpharma.com/biopharm/News/FDA-Authorizes-Emergency-Use-of-Tamiflu-Relenza-to/ArticleStandard/Article/detail/595276?ref=25 In response to requests from the US Centers for Disease Control and Prevention (CDC), the US Food and Drug Administration yesterday authorized the use of the antiviral drugs Tamiflu and Relenza beyond their approved indications in response to the outbreak of swine flu. 2009-04-28T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182009/595276null HTML http://biopharminternational.findpharma.com/biopharm/News/JampJs-Once-Monthly-Simponi-Approved-for-Three-Rhe/ArticleStandard/Article/detail/595236?ref=25 Centocor Ortho Biotech (Horsham, PA), a subsidiary of Johnson & Johnson, received approval from the US Food and Drug Administration on April 24 for Simponi (golimumbad), a monthly treatment for moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis. 2009-04-27T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182009/595236null HTML http://biopharminternational.findpharma.com/biopharm/News/QbD-Case-Study-Will-Push-Limits/ArticleStandard/Article/detail/592288?ref=25 When the final version of the Quality by Design (QbD) case study is made public this summer, it will be an aspirational document, says Ken Seamon, PhD, one of the project?s facilitators. "If the regulatory authorities read our final document and said 'yes, this is all fine,' we will have failed," he said. 2009-04-10T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/152009/592288null HTML http://biopharminternational.findpharma.com/biopharm/News/Roche-Acquires-Innovatis-AG-for-its-Product-Portfo/ArticleStandard/Article/detail/592312?ref=25 Roche (Basel, Switzerland) will acquire 100% of Innovatis, AG (Bielefeld, Germany). 2009-04-10T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/152009/592312null HTML http://biopharminternational.findpharma.com/biopharm/News/SAFC-Converts-Facility-to-Animal-Component-Free-St/ArticleStandard/Article/detail/592291?ref=25 SAFC Biosciences (Lenexa, KS) has completed the conversion of its dry powder cell culture media continuous milling production site in Lenexa, KS to animal component free (ACF) status. This is the first of several similar conversions planned by SAFC Biosciences to support growing customer requirements for ACF manufacturing. 2009-04-10T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/152009/592291null HTML http://biopharminternational.findpharma.com/biopharm/News/Novozymes-Biopharma-Joins-with-GE-Healthcare-to-Pr/ArticleStandard/Article/detail/592310?ref=25 Novozymes Biopharma UK Ltd. (Nottingham, UK) has signed a license agreement with GE Healthcare Life Sciences (Chalfont St. Giles, UK), which enables Novozymes Biopharma to produce and deliver native, animal-free Protein A using GE Healthcare technology. 2009-04-10T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/152009/592310null HTML http://biopharminternational.findpharma.com/biopharm/News/FDA-Guidance-Outlines-CMC-Requirements-for-Cell-Ba/ArticleStandard/Article/detail/592419?ref=25 The US Food and Drug Administration has released a new draft guidance on somatic cell therapies that are designed to advance the treatment of heart disease through the regeneration of cardiac tissues. 2009-04-10T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/152009/592419null HTML http://biopharminternational.findpharma.com/biopharm/News/FDA-Approves-Intercells-Vaccine-Against-Japanese-E/ArticleStandard/Article/detail/592306?ref=25 Intercell AG (Vienna, Switzerland) has received the US Food and Drug Administration?s approval for Ixiaro, a vaccine for the prevention of Japanese Encephalitis (JE). 2009-04-10T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/152009/592306null HTML http://biopharminternational.findpharma.com/biopharm/News/Covance-Receives-cGMP-Manufacturing-License/ArticleStandard/Article/detail/592297?ref=25 Covance Inc. (Princeton, NJ) has completed an additional 8,000-sq. ft. to its biotechnology services facility in Harrogate, UK. 2009-04-10T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/152009/592297null HTML http://biopharminternational.findpharma.com/biopharm/News/Novavax-Forms-Strategic-Alliance-with-Cadila-Pharm/ArticleStandard/Article/detail/592300?ref=25 Novavax, Inc. (Rockville, MD), has formed a joint venture with Cadila Pharmaceuticals, Ltd. (Ahmedabad, India), to develop, manufacture, and market vaccines, pharmaceuticals, and diagnostic products in India. 2009-04-10T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/152009/592300null HTML http://biopharminternational.findpharma.com/biopharm/News/Pall-Licenses-SPFs-TFF-Technology/ArticleStandard/Article/detail/592308?ref=25 Pall Corporation (East Hills, NY) has acquired an exclusive license to manufacture, market, and sell Single Pass TFF (SPTFF), an SPF Innovations, LLC (Watertown, MA) technology for biopharmaceutical applications. 2009-04-10T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/152009/592308null HTML http://biopharminternational.findpharma.com/biopharm/News/BMS-and-ImClone-Recall-Erbitux-Funding/ArticleStandard/Article/detail/592289?ref=25 ImClone Systems, Inc. (Branchburg, NJ), and Bristol-Myers Squibb (BMS, New York, NY) voluntarily recalled 13 lots of their cancer drug Erbitux (cetuximab) after a report from a doctor?s office about a leaking cap on a vial of the biologic. 2009-04-10T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/152009/592289null HTML http://biopharminternational.findpharma.com/biopharm/News/BMS-and-ImClone-Recall-Erbitux/ArticleStandard/Article/detail/592634?ref=25 ImClone Systems, Inc. (Branchburg, NJ), and Bristol-Myers Squibb (BMS, New York, NY) voluntarily recalled 13 lots of their cancer drug Erbitux (cetuximab) after a report from a doctor?s office about a leaking cap on a vial of the biologic. 2009-04-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/152009/592634null HTML http://biopharminternational.findpharma.com/biopharm/BioPharm-Vidcasts-2009/ArticleStandard/Article/detail/592163?ref=25 2009-04-07T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/152009/592163null PDF http://biopharminternational.findpharma.com/biopharm/Outsourcing+Articles/Handling-a-Risky-Business-How-to-Ensure-Successful/ArticleStandard/Article/detail/590355?ref=25 Effective tech transfer can save time and effort in later manufacturing processes. 2009-04-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/142009/590355null XML http://biopharminternational.findpharma.com/biopharm/Cytovance/ArticleStandard/Article/detail/590638?ref=25 2009-04-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/142009/590638null REMOTE http://biopharminternational.findpharma.com/biopharm/Lonza/ArticleStandard/Article/detail/590653?ref=25 2009-04-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/142009/590653null REMOTE http://biopharminternational.findpharma.com/biopharm/Vetter/ArticleStandard/Article/detail/590640?ref=25 2009-04-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/142009/590640null REMOTE http://biopharminternational.findpharma.com/biopharm/Rentschler-Biotechnologie/ArticleStandard/Article/detail/590647?ref=25 2009-04-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/142009/590647null REMOTE http://biopharminternational.findpharma.com/biopharm/Boehringer-Ingelheim/ArticleStandard/Article/detail/590649?ref=25 2009-04-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/142009/590649null REMOTE http://biopharminternational.findpharma.com/biopharm/Laureate-Pharma/ArticleStandard/Article/detail/590654?ref=25 2009-04-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/142009/590654null REMOTE http://biopharminternational.findpharma.com/biopharm/Outsourcing+Articles/FDAs-Recommendations-to-Industry-Regarding-Outsour/ArticleStandard/Article/detail/590354?ref=25 Outsourcing introduces considerable complexity into ensuring compliance with good manufacturing practices. This article offers FDA guidance for how to ensure compliance in the outsourcing environment. 2009-04-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/142009/590354null XML