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. 2009-11-07T15:07:52Z http://biopharminternational.findpharma.com/biopharm/SYNAPT-G2-Breakthrough-Quantitative-and-Qualitativ/ArticleStandard/Article/detail/639523?ref=25 SYNAPT G2: Breakthrough Quantitative and Qualitative Performance for UPLC/MS and MS/MS (MSE) Applications - Waters Whitepaper 2009-11-05T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/452009/639523null PDF http://biopharminternational.findpharma.com/biopharm/News/FDA-Grants-Orphan-Drug-Designation-for-TNFerade/ArticleStandard/Article/detail/639387?ref=25 The US Food and Drug Administration has granted orphan drug designation to GenVec, Inc.'s TNFerade for the treatment of pancreatic cancer. 2009-11-04T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/452009/639387null HTML http://biopharminternational.findpharma.com/biopharm/Xcellerex/ArticleStandard/Article/detail/639408?ref=25 2009-11-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/452009/639408null REMOTE http://biopharminternational.findpharma.com/biopharm/Disposables+Articles/A-Review-of-Sterile-Connectors/ArticleStandard/Article/detail/637917?ref=25 Many factors must be considered when choosing a sterile connector for a given process. 2009-11-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/442009/637917null XML http://biopharminternational.findpharma.com/biopharm/Cuno/ArticleStandard/Article/detail/639404?ref=25 2009-11-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/452009/639404null REMOTE http://biopharminternational.findpharma.com/biopharm/Azopharma/ArticleStandard/Article/detail/639410?ref=25 2009-11-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/452009/639410null REMOTE http://biopharminternational.findpharma.com/biopharm/New-Brunswick-Scientific/ArticleStandard/Article/detail/639403?ref=25 2009-11-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/452009/639403null REMOTE http://biopharminternational.findpharma.com/biopharm/Sartorius-Stedim-Biotech/ArticleStandard/Article/detail/639389?ref=25 2009-11-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/452009/639389null REMOTE http://biopharminternational.findpharma.com/biopharm/Disposables+Articles/Integrating-Single-Use-Connection-Components-into-/ArticleStandard/Article/detail/637585?ref=25 Single-use connections can help drug manufacturers maximize efficiency in every step of the manufacturing process. 2009-11-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/442009/637585null XML http://biopharminternational.findpharma.com/biopharm/Pall-Corporation/ArticleStandard/Article/detail/639409?ref=25 2009-11-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/452009/639409null REMOTE http://biopharminternational.findpharma.com/biopharm/Asahi-Kasei/ArticleStandard/Article/detail/639411?ref=25 2009-11-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/452009/639411null REMOTE http://biopharminternational.findpharma.com/biopharm/Saint-Gobain/ArticleStandard/Article/detail/639405?ref=25 2009-11-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/452009/639405null REMOTE http://biopharminternational.findpharma.com/biopharm/GE-Healthcare/ArticleStandard/Article/detail/639407?ref=25 2009-11-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/452009/639407null REMOTE http://biopharminternational.findpharma.com/biopharm/Millipore/ArticleStandard/Article/detail/639402?ref=25 2009-11-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/452009/639402null REMOTE http://biopharminternational.findpharma.com/biopharm/Disposables+Articles/Freeze-Bulk-Bags-A-Case-Study-in-Disposables-Imple/ArticleStandard/Article/detail/637583?ref=25 Genentech's evaluation of single-use technologies for bulk freeze-thaw, storage, and transportation. 2009-11-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/442009/637583null XML http://biopharminternational.findpharma.com/biopharm/Disposables+Articles/Scale-Up-and-Comparison-Studies-Evaluating-Disposa/ArticleStandard/Article/detail/637918?ref=25 Process performance was comparable across all scales, and fiber optic sensors appeared interchangeable with conventional probes. 2009-11-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/442009/637918null XML http://biopharminternational.findpharma.com/biopharm/GMPs%2FValidation/Residual-Solvents-Alternate-Validated-Methods/ArticleStandard/Article/detail/637865?ref=25 The USP General Chapter <467> on Residual Solvents became effective on July 1, 2008. Alternate methods may need to be developed and validated for compounds and any other unlisted solvents used in manufacturing that cannot be tested by the General Chapter's GC method. Lancaster Laboratories' analysts have been utilizing a technique referred to as a self-validating method. The benefit to this self-validating method approach includes a faster timeline and is more cost effective than the traditional approach for clients having a short term or infrequent need for testing. 2009-10-30T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/442009/637865null REMOTE http://biopharminternational.findpharma.com/biopharm/Residual-Solvents-Alternate-Validated-Methods---La/ArticleStandard/Article/detail/637837?ref=25 Residual Solvents: Alternate Validated Methods - Lancaster Whitepaper 2009-10-30T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/442009/637837null PDF http://biopharminternational.findpharma.com/biopharm/News/Sartorius-Opens-New-Plant-in-India/ArticleStandard/Article/detail/638055?ref=25 In a ribbon-cutting ceremony held on October 30, 2009, Sartorius (Goettingen, Germany) inaugurated its new plant at the Sartorius Group's location in Bangalore, India. 2009-10-30T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/442009/638055null HTML http://biopharminternational.findpharma.com/biopharm/BioPharm-2010-media-kit/ArticleStandard/Article/detail/637541?ref=25 2010 BioPharm media kit 2009-10-29T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/442009/637541null PDF http://biopharminternational.findpharma.com/biopharm/News/New-Influenza-Vaccine-Manufacturing-Facility-in-In/ArticleStandard/Article/detail/637340?ref=25 CPL Biologicals Pvt. Ltd. has begun construction of a state-of-the-art manufacturing facility in India that will be used to produce pandemic and seasonal influenza vaccines. 2009-10-28T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/442009/637340null HTML http://biopharminternational.findpharma.com/biopharm/Online+Only/Online-Exclusive-Sustaining-Operational-Excellence/ArticleStandard/Article/detail/636647?ref=25 To make lasting change, you must first win the hearts and minds of the people on the shop floor. 2009-10-26T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/442009/636647/Fig1_Kouba_rot_flash.jpg HTML http://biopharminternational.findpharma.com/biopharm/News/Letter-to-the-Editor-Re-Diminutive-Bacteria-Useful/ArticleStandard/Article/detail/635704?ref=25 2009-10-22T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/432009/635704null HTML http://biopharminternational.findpharma.com/biopharm/Outsourcing/Professional-Scientific-StaffingsupSMsup-Solutions/ArticleStandard/Article/detail/635572?ref=25 Lancaster Laboratories' Professional Scientific StaffingSM service has been specifically designed to give you the "non-permanent" workforce you need for anywhere from one year to 10 years or more with no worries about co-employment and at lower costs than fixed headcounts. 2009-10-21T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/432009/635572null REMOTE http://biopharminternational.findpharma.com/biopharm/News/Letter-to-the-Editor-Re-Diminutive-Bacteria-Useful/ArticleStandard/Article/detail/635419?ref=25 2009-10-21T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/432009/635419null HTML http://biopharminternational.findpharma.com/biopharm/June-09-BPA-Statement/ArticleStandard/Article/detail/634668?ref=25 June 2009 BPA Statement 2009-10-16T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/422009/634668null PDF http://biopharminternational.findpharma.com/biopharm/News/SAFC-Pharma-Expands-Facility-to-Bolster-Biologics-/ArticleStandard/Article/detail/634326?ref=25 SAFC Pharma has announced the completion of an addition to its Carlsbad, CA, facility, which specializes in the process development and manufacturing of viral vaccines and viral therapeutics. 2009-10-15T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/422009/634326null HTML http://biopharminternational.findpharma.com/biopharm/News/DASGIP-Adds-to-iPhone-Offerings-for-Scientists/ArticleStandard/Article/detail/634399?ref=25 In keeping with the growing trend of iPhone applications for every conceivable convenience, DASGIP AG (Juelich, Germany), a provider of parallel bioreactor systems at benchtop scale, has launched an iPhone application for accessing bioprocesses online. 2009-10-15T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/422009/634399null HTML http://biopharminternational.findpharma.com/biopharm/Analytical-Strategies-for-Monitoring-Residual-Impu/ArticleStandard/Article/detail/633759?ref=25 Analytical Strategies for Monitoring Residual Impurities Encountered In Bioprocessing - Lancaster Whitepaper 2009-10-13T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/422009/633759null PDF http://biopharminternational.findpharma.com/biopharm/Downstream+Processing+Whitepapers/Analytical-Strategies-for-Monitoring-Residual-Impu/ArticleStandard/Article/detail/633766?ref=25 Profiling of impurities in biopharmaceuticals and their associated intermediates and excipients is a regulatory expectation. Since residuals are typically present at low levels in difficult sample matrices, development and validation of assays can be quite challenging. Due to the range of potential impurities, many different analytical strategies are needed. 2009-10-13T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/422009/633766null REMOTE http://biopharminternational.findpharma.com/biopharm/News/Celltrion-and-Hospira-to-Comarket-Celltrions-Biosi/ArticleStandard/Article/detail/633260?ref=25 The Korean CMO Celltrion and Hospira, a small-molecule injectable generics and drug delivery company based in Lake Forest, IL, agree to co-market biosimilars developed by Celltrion. 2009-10-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/422009/633260null HTML http://biopharminternational.findpharma.com/biopharm/Waters-Podcast3-Advances-in-glycan-analysis/ArticleStandard/Article/detail/633443?ref=25 2009-10-12T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/422009/633443null HTML http://biopharminternational.findpharma.com/biopharm/Monitoring-Deamidation-Progression-in-an-Antibody-/ArticleStandard/Article/detail/632729?ref=25 Monitoring Deamidation Progression in an Antibody Tryptic Digest using UPLC/MSE with BiopharmaLynx and a Xevo QTof MS - Waters Whitepaper 2009-10-08T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412009/632729null PDF http://biopharminternational.findpharma.com/biopharm/Online+Only/GSKs-Adjuvanted-Cervical-Cancer-Vaccine-Receives-F/ArticleStandard/Article/detail/632197?ref=25 The US Food and Drug Administration?s Vaccines and Related Biological Products Advisory Committee voted that clinical data support both the efficacy and safety of Cervarix, GlaxoSmithKline?s (GSK, Middlesex, UK) candidate cervical cancer vaccine. 2009-10-07T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412009/632197null HTML http://biopharminternational.findpharma.com/biopharm/Online+Only/Florida-Biologix-Enters-Manufacturing-Agreement-wi/ArticleStandard/Article/detail/632219?ref=25 Florida Biologix (Alachua, FL) has signed a development and manufacturing contract with America Stem Cell (Helotes, TX) for a Phase 1 cell therapy product, ASC-101. ASC-101 is a human recombinant enzyme technology that increases the efficiency of engraftment in transplantation of cord blood derived stem cells. 2009-10-07T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412009/632219null HTML http://biopharminternational.findpharma.com/biopharm/Online+Only/Baxter-Receives-EMEA-Marketing-Authorization-for-C/ArticleStandard/Article/detail/632208?ref=25 Baxter International Inc. (Deerfield, IL) has been granted marketing authorization for Celvapan H1N1 pandemic vaccine using Baxter's Vero cell technology by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA). 2009-10-07T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412009/632208null HTML http://biopharminternational.findpharma.com/biopharm/Online+Only/New-USP-Standards-for-Heparin-Includes-New-Identit/ArticleStandard/Article/detail/632194?ref=25 New heparin standards recently adopted by the United States Pharmacopeia (USP) include new tests to ensure the quality of the drug. 2009-10-07T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412009/632194null HTML http://biopharminternational.findpharma.com/biopharm/Online+Only/FDA-Approves-Biologic-to-Treat-Psoriasis/ArticleStandard/Article/detail/632195?ref=25 The US Food and Drug Administration today approved Stelara (ustekinumab), a biologic manufactured by Centocor Ortho Biotech, Inc. (Horsham, PA),for adults who have a moderate to severe form of psoriasis. 2009-10-07T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412009/632195null HTML http://biopharminternational.findpharma.com/biopharm/Online+Only/Laureate-Pharma-to-Manufacture-Neoprobes-MAb-Produ/ArticleStandard/Article/detail/632220?ref=25 Neoprobe Corporation (Dublin, OH) and Laureate Pharma, Inc. (Princeton, NJ) have entered into a Biopharmaceutical Development and Manufacturing Agreement. 2009-10-07T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412009/632220null HTML http://biopharminternational.findpharma.com/biopharm/Online+Only/Diminutive-Bacteria-Useful-for-02-mum-Filter-Studi/ArticleStandard/Article/detail/632189?ref=25 Diminutive bacteria with the right geometry (i.e. very thin) may be useful for research and development work on sterilizing-grade and other 0.2 uM filters, said Kurt Brorson, PhD, a staff scientist for the FDA/CDER's Division of Monoclonal Antibodies. 2009-10-07T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412009/632189null HTML http://biopharminternational.findpharma.com/biopharm/Whitepapers/Rapid-Growth-of-Full-Time-Equivalent-Staffing-Prog/ArticleStandard/Article/detail/631451?ref=25 With the global economy in a recession, a vast majority of companies are being forced to cut costs and control spending. Full Time Equivalent Staffing Programs are value-added programs that will allow companies to project all of their outsourcing costs for an entire year in order to lock in on set annual costs. 2009-10-05T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412009/631451null REMOTE http://biopharminternational.findpharma.com/biopharm/Rapid-Growth-of-Full-Time-Equivalent-Staffing-Prog/ArticleStandard/Article/detail/631420?ref=25 Rapid Growth of Full Time Equivalent Staffing Programs - BP Whitepaper 2009-10-05T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412009/631420null PDF http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Economic-Drivers-and-Trade-Offs-in-Antibody-Purifi/ArticleStandard/Article/detail/633295?ref=25 The future of therapeutic MAbs lies in the development of economically feasible downstream processes. 2009-10-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/422009/633295null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Virus-Clearance-Strategy-Using-a-Three-Tier-Orthog/ArticleStandard/Article/detail/633293?ref=25 How to implement a risk-based approach to eliminate viruses using orthogonal technologies. 2009-10-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/422009/633293null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Salt-Tolerant-Interaction-Chromatography-for-Large/ArticleStandard/Article/detail/633241?ref=25 STIC allows polishing to be carried out without an interstitial dilution step, which reduces process time and avoids additional buffer preparation and hold steps. 2009-10-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/422009/633241null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Antibody-Purification-Using-Membrane-Adsorbers/ArticleStandard/Article/detail/633290?ref=25 A membrane adsorber in retention mode can be used efficiently in a commercial antibody manufacturing process. 2009-10-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/422009/633290null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Hydrophobic-Membrane-Adsorbers-for-Large-Scale-Dow/ArticleStandard/Article/detail/633242?ref=25 This alternative to column chromatography is suitable for flow-through as well as bind-and-elute purification operations. 2009-10-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/422009/633242null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Precipitation-of-Process-Derived-Impurities-in-Non/ArticleStandard/Article/detail/633294?ref=25 Precipitation prior to capture chromatography offers a simple, robust, and economical method to remove CHO host cell proteins and DNA. 2009-10-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/422009/633294null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/A-Purification-Platform-for-the-Production-of-MAbs/ArticleStandard/Article/detail/633291?ref=25 New techniques can overcome bottlenecks in existing facilities. 2009-10-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/422009/633291null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/The-Development-and-Application-of-a-Monoclonal-An/ArticleStandard/Article/detail/633292?ref=25 A purification scheme to maximize the efficiency of the purification process and product purity while minimizing the development time for early-phase therapeutic antibodies. 2009-10-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/422009/633292null XML http://biopharminternational.findpharma.com/biopharm/Regulatory+Compliance+Articles/FDA-Leaders-Stress-Science-and-Compliance/ArticleStandard/Article/detail/632931?ref=25 Stiffer enforcement of quality standards aims to restore public confidence in agency actions. 2009-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412009/632931null XML http://biopharminternational.findpharma.com/biopharm/Vaccine+Manufacturing+Articles/Innovations-in-Intranasal-Vaccine-Delivery-Technol/ArticleStandard/Article/detail/632937?ref=25 Needle-free vaccine delivery platforms can solve the problems of stockpiling, cold-chain management, and pandemic preparedness. 2009-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412009/632937null XML http://biopharminternational.findpharma.com/biopharm/Vaccine+Manufacturing+Articles/Pandemic-Preparedness-What-More-Can-We-Do/ArticleStandard/Article/detail/633147?ref=25 The industry and government must collaborate to develop robust technologies and quicker, more flexible manufacturing approaches for vaccine development. 2009-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412009/633147null XML http://biopharminternational.findpharma.com/biopharm/Vaccine+Manufacturing+Articles/Advancing-Vaccine-Technology-to-Combat-Global-Pand/ArticleStandard/Article/detail/633146?ref=25 New technologies such as virus-like particles are promising weapons in the battle against pandemic influenza. 2009-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412009/633146null XML http://biopharminternational.findpharma.com/biopharm/Business+Articles/Apply-the-Butterfly-Effect-to-Streamline-Your-Supp/ArticleStandard/Article/detail/632934?ref=25 Small changes can have a big effect further downstream in your manufacturing processes. 2009-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412009/632934null XML http://biopharminternational.findpharma.com/biopharm/Lonza/ArticleStandard/Article/detail/633004?ref=25 2009-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412009/633004null REMOTE http://biopharminternational.findpharma.com/biopharm/New-Brunswick-Scientific/ArticleStandard/Article/detail/633003?ref=25 2009-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412009/633003null REMOTE http://biopharminternational.findpharma.com/biopharm/GE-Healthcare/ArticleStandard/Article/detail/633002?ref=25 2009-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412009/633002null REMOTE http://biopharminternational.findpharma.com/biopharm/Scilog/ArticleStandard/Article/detail/633005?ref=25 2009-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412009/633005null REMOTE http://biopharminternational.findpharma.com/biopharm/Vaccine+Manufacturing+Articles/Tangential-Flow-Filtration-for-the-Recovery-of-Ace/ArticleStandard/Article/detail/633148?ref=25 Membrane-based TFF technology can ease scale-up and provide a higher recovery percentage compared to conventional purification methods. 2009-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412009/633148null XML http://biopharminternational.findpharma.com/biopharm/Manufacturing+Economics+Articles/A-Closer-Look-at-Automated-In-Line-Dilution/ArticleStandard/Article/detail/632935?ref=25 Automated in-line dilution can help solve capacity, financial, and quality concerns that biopharmaceutical manufacturing plants may be facing. 2009-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412009/632935/BP1009_InLine_Dilution_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Manufacturing+Economics+Articles/Harvesting-the-Benefits-of-LEAN-in-Biopharmaceutic/ArticleStandard/Article/detail/632936?ref=25 A step-by-step approach is essential for successful implementation. 2009-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412009/632936/Bp1009_lean_biopharma_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Burrill+on+Biotech/Biotech-Remains-Updeat-During-the-Summer/ArticleStandard/Article/detail/632929?ref=25 Biotech impressed investors with positive drug data, strong drug sales and earnings, and partnering deals. 2009-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412009/632929null XML http://biopharminternational.findpharma.com/biopharm/Pall-Corporation/ArticleStandard/Article/detail/633001?ref=25 2009-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412009/633001null REMOTE http://biopharminternational.findpharma.com/biopharm/Outsourcing+Articles/Building-a-Turnkey-Manufacturing-Solution/ArticleStandard/Article/detail/632933?ref=25 Lonza's bid for Patheon makes the contract manufacturing industry re-examine the one-stop manufacturer model. 2009-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412009/632933null XML http://biopharminternational.findpharma.com/biopharm/From+the+Editor/Pharma-and-Healthcare-Reform-Part-2/ArticleStandard/Article/detail/632932?ref=25 It seems clear that insuring the roughly 46 million Americans who are now uninsured will increase drug sales. 2009-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412009/632932null XML http://biopharminternational.findpharma.com/biopharm/Vaccine+Manufacturing+Articles/Addressing-Unmet-Medical-Needs-Through-Tailored-Va/ArticleStandard/Article/detail/633145?ref=25 It is now possible to combine antigens with specific adjuvant systems to create more effective vaccines. 2009-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412009/633145null XML http://biopharminternational.findpharma.com/biopharm/Manufacturing+Economics+Articles/Biopharmaceuticals-Approval-Trends-in-2008/ArticleStandard/Article/detail/632930?ref=25 Ten biopharmaceuticals gained marketing authorization in the US or EU in 2008, although only four were new approvals. 2009-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412009/632930/BP1009_biopharma_approvals.tif_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Azopharma/ArticleStandard/Article/detail/633000?ref=25 2009-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412009/633000null REMOTE http://biopharminternational.findpharma.com/biopharm/Trends/Contract-Consulting-amp-Pharmaceutical-Services---/ArticleStandard/Article/detail/627961?ref=25 To assess current trends in outsourcing, BioPharm International turned to Mark Douglas, PhD, strategic business development manager, Avecia Biologics Ltd; Geoffrey M. Glass, senior vice president of strategy, corporate development and business integration, Patheon Inc.; Rob Gustines, director of marketing, KBI Biopharma, Inc.; Jon S. Kauffman, PhD, director, method development & method validation and biopharmaceutical services, Lancaster Laboratories; Roger Lias, PhD, president, Eden Biodesign, Inc.; John A. McCarty, vice president, formulation sciences and drug delivery, Azopharma; and Michiel E. Ultee, PhD, vice president, process sciences, Laureate Pharma, Inc. 2009-09-21T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/392009/627961null HTML http://biopharminternational.findpharma.com/biopharm/Trends/Contract-Consulting-amp-Pharmaceutical-Services---/ArticleStandard/Article/detail/627963?ref=25 To assess current trends in outsourcing, BioPharm International turned to Mark Douglas, PhD, strategic business development manager, Avecia Biologics Ltd; Geoffrey M. Glass, senior vice president of strategy, corporate development and business integration, Patheon Inc.; Rob Gustines, director of marketing, KBI Biopharma, Inc.; Jon S. Kauffman, PhD, director, method development & method validation and biopharmaceutical services, Lancaster Laboratories; Roger Lias, PhD, president, Eden Biodesign, Inc.; John A. McCarty, vice president, formulation sciences and drug delivery, Azopharma; and Michiel E. Ultee, PhD, vice president, process sciences, Laureate Pharma, Inc. 2009-09-21T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/392009/627963null HTML http://biopharminternational.findpharma.com/biopharm/Trends/Downstream-Processing/ArticleStandard/Article/detail/627965?ref=25 To assess current trends in separation and purification, BioPharm International turned to Mandar Dixit, head of product management?filtration technologies, Sartorius Stedim Biotech; Günter Jagschies, senior director of strategic customer relations, life sciences, biotechnologies, GE Healthcare; Richard Pearce, program director of purification, Millipore Corporation; and Jon Petrone, global technical director, Pall Life Sciences. 2009-09-21T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/392009/627965null HTML http://biopharminternational.findpharma.com/biopharm/Trends/Contract-Consulting-amp-Pharmaceutical-Services---/ArticleStandard/Article/detail/627940?ref=25 To assess current trends in outsourcing, BioPharm International turned to Mark Douglas, PhD, strategic business development manager, Avecia Biologics Ltd; Geoffrey M. Glass, senior vice president of strategy, corporate development and business integration, Patheon Inc.; Rob Gustines, director of marketing, KBI Biopharma, Inc.; Jon S. Kauffman, PhD, director, method development & method validation and biopharmaceutical services, Lancaster Laboratories; Roger Lias, PhD, president, Eden Biodesign, Inc.; John A. McCarty, vice president, formulation sciences and drug delivery, Azopharma; and Michiel E. Ultee, PhD, vice president, process sciences, Laureate Pharma, Inc. 2009-09-21T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/392009/627940null HTML http://biopharminternational.findpharma.com/biopharm/News/InVitria-Launches-Animal-Origin-Free-Transferrin/ArticleStandard/Article/detail/627496?ref=25 Colorado-based InVitria, a division of the biopharmaceutical company Ventria Bioscience, has launched an animal-free recombinant transferrin for use in mammalian cell culture. 2009-09-18T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/382009/627496null HTML http://biopharminternational.findpharma.com/biopharm/Trends/Single-Use-Bioprocessing-Equipment/ArticleStandard/Article/detail/627768?ref=25 To assess current trends in single-use bioprocessing equipment, BioPharm International turned to John Boehm, bioprocessing business unit manager, Colder Products Company; Mandar Dixit, head of product management?filtration technologies, Sartorius Stedim Biotech; Geoff Hodge, managing director of process technology Xcellerex, Inc.; Günter Jagschies, senior director of strategic customer relations, life sciences, biotechnologies, GE Healthcare; Mani Krishnan, director of product management, Mobius single-use technologies, Millipore Corporation; and Jerry Martin, senior vice president of scientific affairs, Pall Life Sciences, and board chairman and technology chair at BPSA. 2009-09-18T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/382009/627768null HTML http://biopharminternational.findpharma.com/biopharm/Trends/Information-Technology-Automation-and-Process-Cont/ArticleStandard/Article/detail/627748?ref=25 To assess current trends in information technology, automation, and process control, BioPharm International turned to Rick E. Cooley, market development manager?process analytics, Dionex Corporation, and James Erickson, president and chief executive officer, Blue Mountain Quality Resources, Inc. 2009-09-18T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/382009/627748null HTML http://biopharminternational.findpharma.com/biopharm/Trends/Fermentation-and-Cell-Culture/ArticleStandard/Article/detail/627745?ref=25 To assess current trends in fermentation and cell culture equipment, BioPharm International turned to Geoff Hodge, managing director of process technology, Xcellerex, Inc.; Günter Jagschies, senior director of strategic customer relations, life sciences, biotechnologies, GE Healthcare; and Rich Mirro, product manager, New Brunswick Scientific. 2009-09-18T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/382009/627745null HTML http://biopharminternational.findpharma.com/biopharm/Trends/Laboratory-Equipment/ArticleStandard/Article/detail/627754?ref=25 To assess current trends in laboratory equipment, BioPharm International turned to Francis Bach, North American sales director, Asahi Kasei TechniKrom, Inc.; Erika Lapinskas, PhD, product manager, Sartorius Stedim Biotech; Jeffrey R. Mazzeo, PhD, biopharmaceutical business director, Waters Corporation; Amber Ratcliff, product manager, analytical sensors, Hamilton Company; and Josh Silverstone, marketing director, Millipore Corp. 2009-09-18T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/382009/627754null HTML http://biopharminternational.findpharma.com/biopharm/Comprehensive-and-Routine-Characterization-of-Prot/ArticleStandard/Article/detail/627283?ref=25 Comprehensive and Routine Characterization of Proteins and Peptides by LC/MS and LC/MSE 2009-09-17T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/382009/627283null PDF http://biopharminternational.findpharma.com/biopharm/News/FDA-Approves-H1N1-Flu-Vaccines-Produced-in-Eggs/ArticleStandard/Article/detail/626935?ref=25 The US Food and Drug Administration announced yesterday that it has approved four vaccines against the 2009(A)H1N1 (?swine?) influenza virus. 2009-09-16T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/382009/626935null HTML http://biopharminternational.findpharma.com/biopharm/News/Lonza-Building-Cell-Therapy-Facility-in-Singapore/ArticleStandard/Article/detail/625957?ref=25 Lonza (Basel, Switzerland), broke ground earlier this week on a new cell therapy manufacturing facility in Tuas Biomedical Park, Singapore, adjacent to Lonza?s large-scale mammalian manufacturing facility. 2009-09-11T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/372009/625957null HTML http://biopharminternational.findpharma.com/biopharm/News/FDA-Grants-Orphan-Status-to-Protalixs-Gaucher-Dise/ArticleStandard/Article/detail/625455?ref=25 Protalix BioTherapeutics, Inc. (Carmiel, Israel) gained orphan drug status from the US FDA for prGCD, a development drug for Gaucher?s disease, on September 9. The orphan drug designation for prGCD was granted by the FDA?s Office of Orphan Products Development and comes less than a month after the drug received fast-track designation from the FDA. 2009-09-10T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/372009/625455null HTML http://biopharminternational.findpharma.com/biopharm/Online+Only/European-Commission-Approves-Genzymes-Mozobil/ArticleStandard/Article/detail/625098?ref=25 The European Commission has granted marketing authorization for Genzyme Corporation?s (Cambridge, MA) Mozobil (plerixafor injection) for patients with the blood cancers lymphoma and multiple myelomawho require an autologous stem cell transplant. 2009-09-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/372009/625098null HTML http://biopharminternational.findpharma.com/biopharm/Trends/Cleanrooms-amp-Facilities/ArticleStandard/Article/detail/625166?ref=25 To assess current trends in cleanrooms and engineering & facilities, BioPharm International turned to Parrish Galliher, founder and chief technology officer, Xcellerex, Inc.; Jim Maslowski, owner, PDC Aseptic Filling Systems; Morgan Polen, vice president, application technology, Lighthouse Worldwide Solutions; and Benoît Verjans, commercial director, Aseptic Technologies. 2009-09-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/372009/625166null HTML http://biopharminternational.findpharma.com/biopharm/Online+Only/Top-10-Biologics-Sales-Top-41-billion/ArticleStandard/Article/detail/625068?ref=25 Sales of the Top 10 biotech drugs exceeded $41.5 billion in 2008, according to a new report issued by BioWorld Today. 2009-09-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/372009/625068null HTML http://biopharminternational.findpharma.com/biopharm/Online+Only/Catalent-Creates-Business-Unit-Biologics-Developme/ArticleStandard/Article/detail/625099?ref=25 CatalentPharma Solutions (Somerset, NJ) has created a business unit dedicated to helping customers bring new pharmaceutical and biologic products to market. 2009-09-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/372009/625099null HTML http://biopharminternational.findpharma.com/biopharm/Online+Only/Profectus-and-Path-Malaria-Vaccine-Initiative-Ente/ArticleStandard/Article/detail/625100?ref=25 Profectus BioSciences, Inc. (Baltimore, MD), a clinical stage biopharmaceutical company focused on the development of novel vaccine candidates for serious chronic infections, has signed a research collaboration agreement with the PATH Malaria Vaccine Initiative (Bethesda, MD) to conduct proof-of-concept studies with its proprietary, recombinant vesicular stomatitis virus (rVSV) vector technology as a preventative malaria vaccine. 2009-09-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/372009/625100null HTML http://biopharminternational.findpharma.com/biopharm/News/Shire-Completes-NDA-for-Gauchers-Disease-Treatment/ArticleStandard/Article/detail/624341?ref=25 Shire plc (Cambridge, MA) has completed its submission of a new drug application (NDA) for velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Type 1 Gaucher disease, with the US Food and Drug Administration. 2009-09-04T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/362009/624341null HTML http://biopharminternational.findpharma.com/biopharm/Waters-Podcast-Getting-more-specificity-in-host-ce/ArticleStandard/Article/detail/624278?ref=25 2009-09-04T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/362009/624278null HTML http://biopharminternational.findpharma.com/biopharm/News/Novavax-Achieves-Good-Results-for-Vaccines-Against/ArticleStandard/Article/detail/623742?ref=25 Novavax (Rockville, MD) recently achieved positive Phase 2a results for its trivalent virus-like particle (VLP) vaccine against seasonal influenza, and positive preclinical results for a VLP vaccine against H1NI (swine) flu. 2009-09-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/362009/623742null HTML http://biopharminternational.findpharma.com/biopharm/Regulatory+Compliance+Articles/Biopharmaceutical-Manufacturers-Seize-Opportunitie/ArticleStandard/Article/detail/624454?ref=25 The FDA is encouraging manufacturers to invest in research and development for new vaccines and therapeutics to combat third-world diseases. 2009-09-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/372009/624454null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing+Articles/The-Proper-Use-of-47-mm-Flat-Disc-Filters-in-Filte/ArticleStandard/Article/detail/624455?ref=25 Why staining is crucial in flow decay studies. 2009-09-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/372009/624455/Bp0909_filter_sizing_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Business+Articles/Patenting-Biotechnology-Inventions-Will-Become-Mor/ArticleStandard/Article/detail/624458?ref=25 Recent patent rulings raise significant patentability questions for DNA sequence inventions. 2009-09-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/372009/624458null XML http://biopharminternational.findpharma.com/biopharm/Manufacturing+Economics+Articles/Breaking-the-Rapid-Microbiological-Method-Financia/ArticleStandard/Article/detail/624451?ref=25 A case study implementing rapid microbiological methods. 2009-09-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/372009/624451null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing+Articles/Comparison-of-Camelid-Antibody-Ligand-to-Protein-A/ArticleStandard/Article/detail/624453?ref=25 A stable alternative to Protein A chromatography. 2009-09-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/372009/624453/bp0909_CamelidAntibody_Ligand_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Supply+Chain+Management+Articles/Strategic-Outsourcing-of-Media-Design-and-Cell-Cul/ArticleStandard/Article/detail/624457?ref=25 To select the right partner for media design and optimization services, several key factors must be considered. 2009-09-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/372009/624457null XML http://biopharminternational.findpharma.com/biopharm/From+the+Editor/A-True-Assessment-of-Risk/ArticleStandard/Article/detail/624452?ref=25 If risk assessments only identify "the usual suspects," the process will not add much value. 2009-09-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/372009/624452null XML http://biopharminternational.findpharma.com/biopharm/GMPs%2FValidation/Quality-Risk-Management-Demystified-at-CMC-Strateg/ArticleStandard/Article/detail/624456?ref=25 ICH Q9 encourages companies to apply the concept of quality risk management. Easier said than done. 2009-09-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/372009/624456/Bp0909_risk_management_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Comprehensive-Routine-Characterization-of-Proteins/ArticleStandard/Article/detail/621973?ref=25 Comprehensive, Routine Characterization of Proteins and Peptides by LC/MS - Waters WhitePaper Note 2009-08-27T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/352009/621973null PDF http://biopharminternational.findpharma.com/biopharm/News/Pfizer-Unveils-214-Million-Biotech-Facility-in-Swe/ArticleStandard/Article/detail/622127?ref=25 Pharmaceutical giant Pfizer, Inc., (New York, NY) has opened a new 64,600-square-foot biotech plant in Strangnas, Sweden. 2009-08-27T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/352009/622127null HTML