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. 2010-03-18T04:10:21Z http://biopharminternational.findpharma.com/biopharm/News/Contamination-at-Another-Genzyme-Manufacturing-Pla/ArticleStandard/Article/detail/661362?ref=25 On February 12, Genzyme (Cambridge, MA) notified Cerezyme users of an impurity found in a vial manufactured at its Waterford, Ireland plant. 2010-03-15T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/122010/661362null HTML http://biopharminternational.findpharma.com/biopharm/Xcellerex-and-Humacyte-to-Develop-Single-Use-Manuf/ArticleStandard/Article/detail/660754?ref=25 Humacyte, Inc. (Research Triangle Park, NC) and Xcellerex, Inc. (Marlborough, MA) have entered into an initial strategic collaboration for Xcellerex to develop a manufacturing process that will enable the production of Humacyte?s lead regenerative medicine product using Xcellerex?s XDR single-use bioreactor system in its FlexFactory. 2010-03-10T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/112010/660754null HTML http://biopharminternational.findpharma.com/biopharm/Baxter-Receives-Warning-Letter-from-FDA-Regarding-/ArticleStandard/Article/detail/660736?ref=25 On January 15, 2010, Baxter Biosciences (Deerfield, IL) received a warning letter from the US Food and Drug Administration, citing significant deviations from current good manufacturing practices (cGMPs) in the manufacture of Gammagard (human immune globulin) liquid and Gammagard S/D intermediates at its manufacturing facility in Lessines, Belgium. 2010-03-10T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/112010/660736null HTML http://biopharminternational.findpharma.com/biopharm/Project-GreenVax-Promises-to-Shorten-Vaccine-Manuf/ArticleStandard/Article/detail/660756?ref=25 The Texas Plant-Expressed Vaccine Consortium launched Project GreenVax, a biotherapeutic manufacturing initiative that is designed to show proof-of-concept for a technology that could reduce the time to produce vaccines for infectious disease. 2010-03-10T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/112010/660756null HTML http://biopharminternational.findpharma.com/biopharm/FDA-and-EMA-To-Accept-a-Single-Annual-Report-for-O/ArticleStandard/Article/detail/660735?ref=25 The US Food and Drug Administration and the European Medicines Agency (EMA) have agreed to a more streamlined process to help regulators better identify and share information throughout the development process of orphan drug and biologic products, which are developed specifically to treat rare medical conditions. 2010-03-10T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/112010/660735null HTML http://biopharminternational.findpharma.com/biopharm/AmpVacs-Project-Aims-to-Develop-Synthetic-Influenz/ArticleStandard/Article/detail/660758?ref=25 Sanquin Blood Supply Foundation (Amsterdam, the Netherlands), the Netherlands Cancer Institute (Amsterdam, the Netherlands), and the Netherlands Vaccine Institute (Bilthoven, the Netherlands), have launched the AmpVacs project, which aims to develop a broadly protective synthetic influenza A vaccine component. 2010-03-10T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/112010/660758null HTML http://biopharminternational.findpharma.com/biopharm/FDA-Issues-Final-Guidance-to-Boost-Development-of-/ArticleStandard/Article/detail/660734?ref=25 The US Food and Drug Administration has issued final guidance to help manufacturers who are developing cell-based viral vaccines to address emerging and pandemic threats. 2010-03-10T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/112010/660734null HTML http://biopharminternational.findpharma.com/biopharm/Repligen-Acquires-Chromatography-Technology-Platfo/ArticleStandard/Article/detail/660636?ref=25 Repligen Corporation (Waltham, MA) has acquired the assets of BioFlash Partners, LLC (Marlborough, MA), including a technology platform for producing prepacked plug-and-play chromatography columns. 2010-03-09T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/112010/660636null HTML http://biopharminternational.findpharma.com/biopharm/Waters-and-Daiso-Sign-Marketing-Agreement-for-Bulk/ArticleStandard/Article/detail/660642?ref=25 Waters Corporation (Milford, MA) and Daiso Co., Ltd. (Osaka, Japan) have entered into a collaborative agreement to globally market and supply Daisogel bulk packing materials for process chromatography. 2010-03-09T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/112010/660642null HTML http://biopharminternational.findpharma.com/biopharm/Podcast-Solving-Tomorrowacutes-Downstream-Processi/ArticleStandard/Article/detail/660571?ref=25 2010-03-09T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/112010/660571null HTML http://biopharminternational.findpharma.com/biopharm/GMPs%2FValidation/The-Challenge-of-Defining-the-Higher-Order-Structu/ArticleStandard/Article/detail/660222?ref=25 Characterizing the higher order structure (HOS) of protein drugs increases manufacturers' understanding of stability and batch-to-batch variability, and may make it possible to link variants or aggregates to safety and efficacy. Yet at the January 24 CMC Strategy Forum in Washington, DC, regulators expressed concern that methods to characterize the three-dimensional structure of proteins are not routinely applied to biotechnology products. 2010-03-05T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/102010/660222null HTML http://biopharminternational.findpharma.com/biopharm/Online+Only/AstraZeneca-Cuts-500-Jobs-at-US-Headquarters/ArticleStandard/Article/detail/659901?ref=25 AstraZeneca will cut 500 research and development positions at its US headquarters in Fairfax, DE. 2010-03-03T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/102010/659901null HTML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing+Articles/The-Time-Value-of-Information-in-Designing-Downstr/ArticleStandard/Article/detail/659498?ref=25 To speed up the downstream process, you must get the right data, in the right amount, at the right time. Here's how. 2010-03-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/102010/659498null XML http://biopharminternational.findpharma.com/biopharm/Mallinckrodt-Baker/ArticleStandard/Article/detail/659546?ref=25 2010-03-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/102010/659546null REMOTE http://biopharminternational.findpharma.com/biopharm/Downstream+Processing+Articles/Mixed-Mode-Chromatography-in-Downstream-Process-De/ArticleStandard/Article/detail/659499?ref=25 Salt-tolerant adsorption and unique selectivity are the major advantages of mixed-mode materials over single-mode resins. 2010-03-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/102010/659499null XML http://biopharminternational.findpharma.com/biopharm/News/FDA-Approves-Shires-New-Gaucher-Drug/ArticleStandard/Article/detail/659528?ref=25 The US Food and Drug Administration has approved velaglucerase alfa for injection (VPRIV) to treat children and adults with a form of the rare genetic disorder Gaucher disease. 2010-03-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/102010/659528null HTML http://biopharminternational.findpharma.com/biopharm/Pall-Corporation/ArticleStandard/Article/detail/659549?ref=25 2010-03-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/102010/659549null REMOTE http://biopharminternational.findpharma.com/biopharm/Sartorius-Stedim-Biotech/ArticleStandard/Article/detail/659552?ref=25 2010-03-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/102010/659552null REMOTE http://biopharminternational.findpharma.com/biopharm/Tosoh-Bioscience/ArticleStandard/Article/detail/659551?ref=25 2010-03-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/102010/659551null REMOTE http://biopharminternational.findpharma.com/biopharm/Cuno-Incorporated/ArticleStandard/Article/detail/659547?ref=25 2010-03-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/102010/659547null REMOTE http://biopharminternational.findpharma.com/biopharm/Downstream+Processing+Articles/PEG-Precipitation-A-Powerful-Tool-for-Monoclonal-A/ArticleStandard/Article/detail/659496?ref=25 This alternative purification method to chromatography is readily scalable and fits a fully disposable downstream process. 2010-03-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/102010/659496null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing+Articles/Advances-in-Monoclonal-Antibody-Purification/ArticleStandard/Article/detail/659497?ref=25 New technologies and adaptations of existing technologies can improve platform processes. 2010-03-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/102010/659497null XML http://biopharminternational.findpharma.com/biopharm/From+the+Editor/Lessons-from-the-War-on-Terrorism/ArticleStandard/Article/detail/659502?ref=25 Sharing information is a critical part of security—whether we're protecting travelers from bombs or patients from adulterated medicines. 2010-03-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/102010/659502null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing+Articles/Characterizing-the-Formulation-Design-Space/ArticleStandard/Article/detail/659506?ref=25 Design of experiments is a valuable tool for identifying aspects of a formulation that are critical to product quality. 2010-03-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/102010/659506null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Trends/Downstream-Processing-Promising-Technologies-are-o/ArticleStandard/Article/detail/659503?ref=25 The new technologies being developed to improve downstream systems go beyond traditional chromatography. 2010-03-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/102010/659503null XML http://biopharminternational.findpharma.com/biopharm/Regulatory+Compliance+Articles/Corrective-and-Preventative-Action-Programs-A-Mech/ArticleStandard/Article/detail/659504?ref=25 An effective CAPA plan provides a mechanism for responding to the unexpected. 2010-03-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/102010/659504null XML http://biopharminternational.findpharma.com/biopharm/Final+Word/Quality-Considerations-for-Peptide-Manufacturing-P/ArticleStandard/Article/detail/659505?ref=25 As a key element in the peptide production process, quality should be built into every step. 2010-03-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/102010/659505null XML http://biopharminternational.findpharma.com/biopharm/Regulatory+Compliance+Articles/FDA-Seeks-More-Timely-Drug-Information-Electronica/ArticleStandard/Article/detail/659508?ref=25 The new Sentinel system aims to expand access to data on medical product safety and patient effects. 2010-03-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/102010/659508null XML http://biopharminternational.findpharma.com/biopharm/Outsourcing+Articles/The-Role-of-Process-History-in-Establishing-Clear-/ArticleStandard/Article/detail/659500?ref=25 Sufficient process history is key to the rapid transfer of your process. 2010-03-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/102010/659500null XML http://biopharminternational.findpharma.com/biopharm/Outsourcing+Articles/Indias-Future-as-a-Biologics-Manufacturing-Hub/ArticleStandard/Article/detail/659501?ref=25 Collaborations between Western and Indian companies may provide the best path for offshoring successfully and for developing India's readiness. 2010-03-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/102010/659501null XML http://biopharminternational.findpharma.com/biopharm/Manufacturing+Economics+Articles/Mathematical-Programming-for-the-Design-and-Analys/ArticleStandard/Article/detail/659507?ref=25 The use of mathematical programming methods for automated schedule generation. 2010-03-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/102010/659507null XML http://biopharminternational.findpharma.com/biopharm/Online+Only/Merck-KGaA-to-Buy-Millipore-for-72-Billion/ArticleStandard/Article/detail/659264?ref=25 German pharmaceutical and chemicals company Merck KGaA will buy US biotech equipment-maker Millipore for $7.2 billion. 2010-03-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/102010/659264null HTML http://biopharminternational.findpharma.com/biopharm/Online+Only/Lilly-Receives-FDA-Warning-Letter/ArticleStandard/Article/detail/658898?ref=25 Eli Lilly & Company received a warning letter from the US Food and Drug Administration, citing significant deviations from current good manufacturing practices (cGMP) in the manufacture of active pharmaceutical ingredients (APIs) at its facility in Carolina, Puerto Rico. 2010-02-25T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/092010/658898null HTML http://biopharminternational.findpharma.com/biopharm/News/FDA-Approves-Pfizers-Prevnar-13-for-the-Prevention/ArticleStandard/Article/detail/658609?ref=25 The US Food and Drug Administration has approved Prevnar 13, a pneumococcal 13-valent conjugate vaccine for infants and young children ages six weeks through five years, manufactured by Wyeth Pharmaceuticals, Inc. (Collegeville, PA), a wholly owned subsidiary of Pfizer, Inc. 2010-02-24T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/092010/658609null HTML http://biopharminternational.findpharma.com/biopharm/News/FDA-Approves-Rituxan-for-Chronic-Lymphocytic-Leuke/ArticleStandard/Article/detail/657943?ref=25 The US Food and Drug Administration has approved Rituxan (rituximab) to treat certain patients with chronic lymphocytic leukemia. 2010-02-19T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/082010/657943null HTML http://biopharminternational.findpharma.com/biopharm/News/Sanofi-Pasteur-Expands-Recall-of-H1N1-Vaccine/ArticleStandard/Article/detail/657640?ref=25 Sanofi Pasteur (Lyon, France) has recalled an additional six lots of its Influenza A (H1N1) 2009 Monovalent Vaccine in prefilled syringes after routine testing found that the antigen content had declined below the specification limit. 2010-02-17T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/082010/657640null HTML http://biopharminternational.findpharma.com/biopharm/Online+Only/Merck-to-Cut-17500-Jobs-by-2012/ArticleStandard/Article/detail/657633?ref=25 Merck & Co. (Whitehouse Station, NJ) has announced restructuring plans that include reducing its companywide workforce by 15% by the end of 2012. 2010-02-17T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/082010/657633null HTML http://biopharminternational.findpharma.com/biopharm/News/Novavax-Terminates-Negotiations-with-ROVI-Pharmace/ArticleStandard/Article/detail/656281?ref=25 Novavax will discontinue negotiations for the previously announced collaboration with Madrid-based ROVI Pharmaceuticals. 2010-02-12T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/072010/656281null HTML http://biopharminternational.findpharma.com/biopharm/News/What-Will-Pfizer-Do-With-79-Manufacturing-Plants/ArticleStandard/Article/detail/656147?ref=25 Following its recent acquisition of Wyeth, Pfizer has 79 manufacturing plants around the world?43 from Pfizer and 36 from Wyeth-and relationships with about 250 contract manufacturers. It?s a wealth of resources, which altogether make 32,000 SKUs. Now, how to consolidate it all? 2010-02-12T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/072010/656147null HTML http://biopharminternational.findpharma.com/biopharm/News/TenX-Biopharma-Licenses-Zanolimumab-from-Genmab/ArticleStandard/Article/detail/656167?ref=25 TenX Biopharma, Inc. (Philadelphia, PA) has signed a licensing agreement to acquire exclusive worldwide rights to develop and commercialize zanolimumab (HuMax-CD4) from Genmab A/S (Copenhagen, Denmark). 2010-02-11T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/072010/656167null HTML http://biopharminternational.findpharma.com/biopharm/News/Repligen-Continues-as-GEs-Main-Provider-of-Recombi/ArticleStandard/Article/detail/656165?ref=25 Repligen Corporation (Waltham, MA) has extended its longstanding relationship with GE Healthcare Bio-Sciences AB by entering into a five-year supply agreement for recombinant Protein A, a consumable used in the manufacture of monoclonal antibodies (MAbs). 2010-02-11T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/072010/656165null HTML http://biopharminternational.findpharma.com/biopharm/News/Drug-Enhances-H1N1-Vaccine-Response/ArticleStandard/Article/detail/656164?ref=25 SciClone Pharmaceuticals, Inc. (Foster City, CA) and its partner Sigma-Tau, S.p.A. (Rome, Italy) have received initial topline results in a clinical study evaluating the potential of Zadaxin (thymalfasin) to enhance immune response to the MF59 adjuvanted H1N1 influenza monovalent vaccine, Focetria, from Novartis (Basel, Switzerland). 2010-02-11T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/072010/656164null HTML http://biopharminternational.findpharma.com/biopharm/News/Pneumococcal-Conjugate-Vaccine-Development-Aided-b/ArticleStandard/Article/detail/656162?ref=25 The US Food and Drug Administration will collaborate with PATH to advance development of a conjugate vaccine to protect children against diseases caused by Streptococcus pneumoniae (pneumococcus), especially pneumonia. 2010-02-11T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/072010/656162null HTML http://biopharminternational.findpharma.com/biopharm/News/Workshops-Related-to-the-A-MAb-Case-Study/ArticleStandard/Article/detail/656198?ref=25 Workshops Based on the A-MAb Case Study 2010-02-11T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/072010/656198null HTML http://biopharminternational.findpharma.com/biopharm/News/GSK-Opens-Up-Its-Databases-to-Fight-Malaria/ArticleStandard/Article/detail/656161?ref=25 GlaxoSmithKline (GSK, London, UK) has begun a series of initiatives, which aim at combating diseases that affect the world?s poorest countries. 2010-02-11T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/072010/656161null HTML http://biopharminternational.findpharma.com/biopharm/News/Vivalis-Acquires-New-Platform-for-Generating-Human/ArticleStandard/Article/detail/656158?ref=25 Vivalis (Nantes, France) has acquired Humalys SAS, a private French biotech research and development company based in Lyon, specialized in the generation of human MAbs. 2010-02-11T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/072010/656158null HTML http://biopharminternational.findpharma.com/biopharm/Multimedia/PodcastPfizeracutes-Maddaluna-on-Integrating-Wyeth/ArticleStandard/Article/detail/656086?ref=25 2010-02-09T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/072010/656086null HTML http://biopharminternational.findpharma.com/biopharm/Upstream++Processing+Whitepapers/In-Vivo-Spectroscopy-Studies-of-Skin-and-Cartilage/ArticleStandard/Article/detail/656217?ref=25 Non-ivasive FTIR is used to study skin chemistry and identify diseased cartilage tissue. 2010-02-09T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/072010/656217null REMOTE http://biopharminternational.findpharma.com/biopharm/Upstream++Processing+Whitepapers/Reaction-and-Process-Monitoring-Tracking-an-Interm/ArticleStandard/Article/detail/656207?ref=25 In situ FTIR is coupled with reaction analysis software to track the formation and disappearance of a reaction intermediate. 2010-02-09T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/072010/656207null REMOTE http://biopharminternational.findpharma.com/biopharm/Upstream++Processing+Whitepapers/Reaction-and-Process-Monitoring-Crystallization/ArticleStandard/Article/detail/656215?ref=25 Monitoring a crystallization using temperature-corrected in-situ FTIR. 2010-02-09T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/072010/656215null REMOTE http://biopharminternational.findpharma.com/biopharm/Upstream+Processing/Fermentation-Monitoring-Dissolved-Carbon-Dioxide/ArticleStandard/Article/detail/656205?ref=25 In-situ FTIR is used to measure the conversion of sugars and the evolution of dissolvec carbon dioxide inside a fermenter in real time. 2010-02-09T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/072010/656205null REMOTE http://biopharminternational.findpharma.com/biopharm/Upstream++Processing+Whitepapers/Fermentation-Monitoring-Mammalian-Cell-Culture/ArticleStandard/Article/detail/656213?ref=25 A fully sterilizable analysis head is used for FTIR monitoring of a CHO culture. 2010-02-09T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/072010/656213null REMOTE http://biopharminternational.findpharma.com/biopharm/In-Vivo-Spectroscopy-Studies-of-Skin-and-Cartilage/ArticleStandard/Article/detail/655846?ref=25 In-Vivo Spectroscopy: Studies of Skin and Cartilage - Remspec Whitepaper 2010-02-08T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/072010/655846null PDF http://biopharminternational.findpharma.com/biopharm/Remspec-Accela-Form---In-Vivo-Spectroscopy-Studies/ArticleStandard/Article/detail/655848?ref=25 Remspec Accela Form - In-Vivo Spectroscopy: Studies of Skin and Cartilage 2010-02-08T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/072010/655848null HTML http://biopharminternational.findpharma.com/biopharm/Fermentation-Monitoring-Dissolved-Carbon-Dioxide--/ArticleStandard/Article/detail/655715?ref=25 Fermentation Monitoring: Dissolved Carbon Dioxide - Remspec Whitepaper 2010-02-05T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/062010/655715null PDF http://biopharminternational.findpharma.com/biopharm/Reaction-and-Process-Monitoring-Tracking-an-Interm/ArticleStandard/Article/detail/655717?ref=25 Reaction and Process Monitoring: Tracking an Intermediate - Remspec Whitepaper 2010-02-05T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/062010/655717null PDF http://biopharminternational.findpharma.com/biopharm/Remspec-Accela-Form---Fermentation-Monitoring-Mamm/ArticleStandard/Article/detail/655720?ref=25 Remspec Accela Form - Fermentation Monitoring: Mammalian Cell Culture 2010-02-05T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/062010/655720null HTML http://biopharminternational.findpharma.com/biopharm/Remspec-Accela-Form---Reaction-and-Process-Monitor/ArticleStandard/Article/detail/655723?ref=25 Remspec Accela Form - Reaction and Process Monitoring: Crystallization 2010-02-05T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/062010/655723null HTML http://biopharminternational.findpharma.com/biopharm/Remspec-Accela-Form---Reaction-and-Process-Monitor/ArticleStandard/Article/detail/655718?ref=25 Remspec Accela Form - Reaction and Process Monitoring: Tracking an Intermediate 2010-02-05T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/062010/655718null HTML http://biopharminternational.findpharma.com/biopharm/Fermentation-Monitoring-Mammalian-Cell-Culture---R/ArticleStandard/Article/detail/655719?ref=25 Fermentation Monitoring: Mammalian Cell Culture - Remspec Whitepaper 2010-02-05T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/062010/655719null PDF http://biopharminternational.findpharma.com/biopharm/Remspec-Accela-Form---Fermentation-Monitoring-Diss/ArticleStandard/Article/detail/655716?ref=25 Remspec Accela Form - Fermentation Monitoring: Dissolved Carbon Dioxide 2010-02-05T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/062010/655716null HTML http://biopharminternational.findpharma.com/biopharm/Reaction-and-Process-Monitoring-Crystallization---/ArticleStandard/Article/detail/655721?ref=25 Reaction and Process Monitoring: Crystallization - Remspec Whitepaper 2010-02-05T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/062010/655721null PDF http://biopharminternational.findpharma.com/biopharm/Podcast---Quality-by-Design-Where-We-Stand-Now/ArticleStandard/Article/detail/655410?ref=25 2010-02-04T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/062010/655410null HTML http://biopharminternational.findpharma.com/biopharm/News/Watson-Pharmaceuticals-Acquires-Eden-Biodesign/ArticleStandard/Article/detail/655517?ref=25 Watson Pharmaceuticals has acquired Eden Biodesign for $15 million. 2010-02-04T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/062010/655517null HTML http://biopharminternational.findpharma.com/biopharm/Quality/Bioterminology/ArticleStandard/Article/detail/654740?ref=25 A Guide to the Biopharmaceutical Lexicon, 2010 edition 2010-02-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/062010/654740null XML http://biopharminternational.findpharma.com/biopharm/Quality/Podcast-Series/ArticleStandard/Article/detail/654741?ref=25 UPLC, QTof, HDMS, and more: A practical guide to the hottest techniques driving the future of biopharmaceutical science. 2010-02-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/062010/654741null XML http://biopharminternational.findpharma.com/biopharm/Quality/Resources/ArticleStandard/Article/detail/654739?ref=25 If you are looking for additional information (or terms not included in our glossary), here are some places to begin your search. 2010-02-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/062010/654739null XML http://biopharminternational.findpharma.com/biopharm/Disposables+Advisor/End-to-End-Deployment-of-Single-Use-Technology-in-/ArticleStandard/Article/detail/654421?ref=25 How this Big Pharma company successfully implemented disposable technologies in its manufacturing plant. 2010-02-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/052010/654421null XML http://biopharminternational.findpharma.com/biopharm/From+the+Editor/QbD-Gains-Momentum/ArticleStandard/Article/detail/654420?ref=25 One might look at QbD's plodding growth and conclude that it is never going to make it to graduation. 2010-02-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/052010/654420null XML http://biopharminternational.findpharma.com/biopharm/Regulatory+Compliance+Articles/Biotech-Manufacturing-Under-Scrutiny/ArticleStandard/Article/detail/654422?ref=25 Trouble at Genzyme and with flu vaccine production illustrates the challenges in producing safe and potent biologics. 2010-02-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/052010/654422null XML http://biopharminternational.findpharma.com/biopharm/Outsourcing+Articles/Cautious-Hopefullness-Contract-Services-Industrys-/ArticleStandard/Article/detail/654417?ref=25 As facility closures and layoffs continue, CRO and CMO executives are hoping for a better year, despite few positive signs. 2010-02-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/052010/654417null XML http://biopharminternational.findpharma.com/biopharm/Quality/Statistical-Equivalence-Testing-for-Assessing-Benc/ArticleStandard/Article/detail/654419?ref=25 The two-one-sided t-test compares the equivalency of two data sets. 2010-02-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/052010/654419/Rathore_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Manufacturing+Economics+Articles/Mathematical-Programming-for-the-Design-and-Analys/ArticleStandard/Article/detail/654416?ref=25 How to improve facility design and predict capacity. 2010-02-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/052010/654416/Devens_LSCC_Media_Prep_01_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/News/FDA-Requests-403-Billion-for-FY2011-a-23-Increase/ArticleStandard/Article/detail/655172?ref=25 The US Food and Drug Administration is requesting $4.03 billion to promote and protect public health as part of the President's fiscal year 2011 budget?a 23% increase over the agency?s current $3.28 billion budget. 2010-02-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/062010/655172null HTML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing+Articles/The-Purification-of-Plasmid-DNA-for-Clinical-Trial/ArticleStandard/Article/detail/654418?ref=25 Membrane chromatography ensures purity at high flow rates. 2010-02-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/052010/654418/bp0210_pDNA_purification_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/News/AstraZeneca-Drops-the-Axe-Again-and-Cuts-8000-Jobs/ArticleStandard/Article/detail/654278?ref=25 London-based pharmaceutical company AstraZeneca plans to slash 8,000 jobs, or 12% of its work force, by 2014 to cut costs. 2010-01-29T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/052010/654278null HTML http://biopharminternational.findpharma.com/biopharm/New-ACQUITY-UPLC-H-Class-System-Reliable-Peptide-M/ArticleStandard/Article/detail/653857?ref=25 New ACQUITY UPLC H-Class System: Reliable Peptide Mapping - Waters Apps Note 2010-01-27T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/052010/653857null PDF http://biopharminternational.findpharma.com/biopharm/Waters-Accela-Form---New-ACQUITY-UPLC-H-Class-Syst/ArticleStandard/Article/detail/653867?ref=25 Waters Accela Form - New ACQUITY UPLC H-Class System: Reliable Peptide Mapping 2010-01-27T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/052010/653867null HTML http://biopharminternational.findpharma.com/biopharm/Multimedia/Episode-Number-5-Advancing-Peptide-Mapping-with-In/ArticleStandard/Article/detail/652792?ref=25 2010-01-20T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/042010/652792null REMOTE http://biopharminternational.findpharma.com/biopharm/Podcasts/Waters-Podcast--Episode-5/ArticleStandard/Article/detail/652625?ref=25 2010-01-19T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/042010/652625null HTML http://biopharminternational.findpharma.com/biopharm/News/FDA-Approves-MAb-for-Rheumatoid-Arthritis/ArticleStandard/Article/detail/651690?ref=25 The US Food and Drug Administration has approved Genentech's Actemra (tocilizumab) to treat adults with moderate to severe rheumatoid arthritis who have not adequately responded to or cannot tolerate other approved therapies for rheumatoid arthritis. 2010-01-15T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/032010/651690null HTML http://biopharminternational.findpharma.com/biopharm/Multimedia/Quality-by-Design-in-Biotech-Keys-to-Implementatio/ArticleStandard/Article/detail/652156?ref=25 2010-01-15T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/032010/652156null REMOTE http://biopharminternational.findpharma.com/biopharm/News/FDA-Approves-Sanofis-High-Dose-Flu-Vaccine-for-Peo/ArticleStandard/Article/detail/651693?ref=25 The US Food and Drug Administration has approved Sanofi Pasteur's Fluzone High-Dose, an inactivated influenza virus vaccine for people ages 65 years and older, to prevent disease caused by influenza virus subtypes A and B. 2010-01-15T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/032010/651693null HTML http://biopharminternational.findpharma.com/biopharm/News/Phase-1-2-Completed-for-Universal-Influenza-Vaccin/ArticleStandard/Article/detail/651691?ref=25 BiondVax Pharmaceuticals Ltd, an Israeli biopharmaceutical company, has completed Phase 1-2 clinical trials of its Multimeric-001 universal flu vaccine. 2010-01-15T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/032010/651691null HTML http://biopharminternational.findpharma.com/biopharm/News/Shire-Files-Marketing-Applications-for-Fabry-and-G/ArticleStandard/Article/detail/651680?ref=25 Shire plc (Cambridge, MA) has submitted a biologics license application (BLA) with the FDA for Replagal (agalsidase alfa), its enzyme replacement therapy for Fabry disease. 2010-01-15T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/032010/651680null HTML http://biopharminternational.findpharma.com/biopharm/Multimedia/Extractables-amp-Leachables-Testing-for-Single-Use/ArticleStandard/Article/detail/652155?ref=25 2010-01-15T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/032010/652155null REMOTE http://biopharminternational.findpharma.com/biopharm/Multimedia/Addressing-the-Challenges-of-Downstream-Processing/ArticleStandard/Article/detail/652157?ref=25 2010-01-15T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/032010/652157null REMOTE http://biopharminternational.findpharma.com/biopharm/News/Sanofi-Pasteur-Partners-with-KaloBios-on-Novel-Bio/ArticleStandard/Article/detail/651692?ref=25 Sanofi Pasteur, the vaccines division of the Sanofi-Aventis Group, has signed an agreement with KaloBios Pharmaceuticals for the development of humanized antibody fragment to both treat and prevent Pseudomonas aeruginosa infections. 2010-01-15T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/032010/651692null HTML http://biopharminternational.findpharma.com/biopharm/News/Gender-Gap-is-Getting-Narrower-in-the-Biopharmaceu/ArticleStandard/Article/detail/651674?ref=25 The results of BioPharm International's fourth annual salary survey, conducted in the fall of 2009, shows that women lag behind their male counterparts. 2010-01-15T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/032010/651674null HTML http://biopharminternational.findpharma.com/biopharm/Multimedia/Characterizing-Protein-Products-Critical-Questions/ArticleStandard/Article/detail/652158?ref=25 2010-01-15T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/032010/652158null REMOTE http://biopharminternational.findpharma.com/biopharm/Multimedia/Biopharmaceutical-Job-Market-2010-and-Beyond/ArticleStandard/Article/detail/651753?ref=25 2010-01-15T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/032010/651753null HTML http://biopharminternational.findpharma.com/biopharm/Buyers-Guide-Form/ArticleStandard/Article/detail/651978?ref=25 Buyer's Guide Form 2010-01-14T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/032010/651978null HTML http://biopharminternational.findpharma.com/biopharm/News/Where-Will-Biopharma-Hiring-Take-Place-in-2013/ArticleStandard/Article/detail/651433?ref=25 2010-01-12T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/032010/651433null HTML http://biopharminternational.findpharma.com/biopharm/News/Genzyme-Outsources-Fill-Finish-Operations-to-Hospi/ArticleStandard/Article/detail/650941?ref=25 Genzyme (Cambridge, MA) will outsource fill-and-finish operations for its drugs Cerezyme, Fabrazyme, Myozyme, and Thyrogen to Illinois-based Hospira, Inc. 2010-01-08T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/022010/650941null HTML http://biopharminternational.findpharma.com/biopharm/New-Brunswick-Scientific/ArticleStandard/Article/detail/650869?ref=25 2010-01-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/022010/650869null REMOTE http://biopharminternational.findpharma.com/biopharm/Vaccine+Manufacturing+Articles/Optimizing-Vaccine-Adjuvant-Filtration/ArticleStandard/Article/detail/650827?ref=25 The viscosity of oily emulsions can reduce filter capacity and bacterial retention. 2010-01-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/022010/650827null XML http://biopharminternational.findpharma.com/biopharm/Vaccine+Manufacturing+Articles/New-Approaches-to-Improved-Vaccine-Manufacturing-i/ArticleStandard/Article/detail/650825?ref=25 Recombinant vector technologies can improve the yield and lower the cost of egg-based influenza vaccine production. 2010-01-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/022010/650825null XML http://biopharminternational.findpharma.com/biopharm/Catalent-Pharma-Solutions/ArticleStandard/Article/detail/650868?ref=25 2010-01-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/022010/650868null REMOTE http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Advancing-Adjuvants-and-Vaccine-Delivery-Systems-f/ArticleStandard/Article/detail/651187?ref=25 This article presents ongoing research at VIDO-InterVac for the development of safer and more effective adjuvants. These include adjuvants that stimulate innate immunity in the body and combination adjuvants. 2010-01-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/032010/651187null HTML http://biopharminternational.findpharma.com/biopharm/Xcellerex/ArticleStandard/Article/detail/650870?ref=25 2010-01-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/022010/650870null REMOTE