http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Article/list/39223 The separation and purification steps of biotech processing, including chromatography and filtration. Vaccine and monoclonal antibody (MAb) manufacturing are also found here. 2009-11-21T13:38:39Z http://biopharminternational.findpharma.com/biopharm/GMPs%2FValidation/To-FIT-or-Not-to-FIT-That-is-the-Question/ArticleStandard/Article/detail/640114?contextCategoryId=39223&ref=25 A risk-based approach for real-world situations. 2009-11-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/452009/640114null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing+Whitepapers/Analytical-Strategies-for-Monitoring-Residual-Impu/ArticleStandard/Article/detail/633766?contextCategoryId=39223&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/Downstream+Processing/A-Purification-Platform-for-the-Production-of-MAbs/ArticleStandard/Article/detail/633291?contextCategoryId=39223&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/Precipitation-of-Process-Derived-Impurities-in-Non/ArticleStandard/Article/detail/633294?contextCategoryId=39223&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/The-Development-and-Application-of-a-Monoclonal-An/ArticleStandard/Article/detail/633292?contextCategoryId=39223&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/Downstream+Processing/Antibody-Purification-Using-Membrane-Adsorbers/ArticleStandard/Article/detail/633290?contextCategoryId=39223&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/Salt-Tolerant-Interaction-Chromatography-for-Large/ArticleStandard/Article/detail/633241?contextCategoryId=39223&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/Virus-Clearance-Strategy-Using-a-Three-Tier-Orthog/ArticleStandard/Article/detail/633293?contextCategoryId=39223&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/Hydrophobic-Membrane-Adsorbers-for-Large-Scale-Dow/ArticleStandard/Article/detail/633242?contextCategoryId=39223&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/Economic-Drivers-and-Trade-Offs-in-Antibody-Purifi/ArticleStandard/Article/detail/633295?contextCategoryId=39223&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/Vaccine+Manufacturing+Articles/Pandemic-Preparedness-What-More-Can-We-Do/ArticleStandard/Article/detail/633147?contextCategoryId=39223&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/Manufacturing+Economics+Articles/A-Closer-Look-at-Automated-In-Line-Dilution/ArticleStandard/Article/detail/632935?contextCategoryId=39223&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/Vaccine+Manufacturing+Articles/Innovations-in-Intranasal-Vaccine-Delivery-Technol/ArticleStandard/Article/detail/632937?contextCategoryId=39223&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/Tangential-Flow-Filtration-for-the-Recovery-of-Ace/ArticleStandard/Article/detail/633148?contextCategoryId=39223&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/Vaccine+Manufacturing+Articles/Advancing-Vaccine-Technology-to-Combat-Global-Pand/ArticleStandard/Article/detail/633146?contextCategoryId=39223&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/Vaccine+Manufacturing+Articles/Addressing-Unmet-Medical-Needs-Through-Tailored-Va/ArticleStandard/Article/detail/633145?contextCategoryId=39223&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/Trends/Downstream-Processing/ArticleStandard/Article/detail/627965?contextCategoryId=39223&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/Downstream+Processing+Articles/The-Proper-Use-of-47-mm-Flat-Disc-Filters-in-Filte/ArticleStandard/Article/detail/624455?contextCategoryId=39223&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/Downstream+Processing+Articles/Comparison-of-Camelid-Antibody-Ligand-to-Protein-A/ArticleStandard/Article/detail/624453?contextCategoryId=39223&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/Quality/Analytical-Tools-for-Process-and-Product-Character/ArticleStandard/Article/detail/615148?contextCategoryId=39223&ref=25 Select the best approach to determine critical quality attributes. 2009-08-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/312009/615148/bp0809_analytical_tools_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing+Articles/Using-Metabolic-Profiling-Technology-to-Advance-Ce/ArticleStandard/Article/detail/601190?contextCategoryId=39223&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/Production-Strategies-for-Antibody-Fragment-Therap/ArticleStandard/Article/detail/601148?contextCategoryId=39223&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/Downstream+Processing+Articles/The-Impact-of-Cell-Culture-Medium-on-Cell-Line-and/ArticleStandard/Article/detail/601146?contextCategoryId=39223&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?contextCategoryId=39223&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/Using-Fluorescence--Based-Sensing-to-Accelerate-Pr/ArticleStandard/Article/detail/601409?contextCategoryId=39223&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/Downstream+Processing+Articles/Best-Practices-for-Formulation-and-Manufacturing-o/ArticleStandard/Article/detail/601406?contextCategoryId=39223&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/Vaccine+Manufacturing+Articles/Funding-Biodefense-Vaccine-Development/ArticleStandard/Article/detail/590352?contextCategoryId=39223&ref=25 Biodefense start-up companies have an abundance of options when seeking funding. 2009-04-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/142009/590352/bp0409_Biodefense_Vaccine_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing+Articles/Opalescence-of-an-IgG1-MAb-Formulation-is-Mediated/ArticleStandard/Article/detail/590350?contextCategoryId=39223&ref=25 Can increase in ionic strength result in higher viscosity? 2009-04-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/142009/590350/bp0409_MAb_opalescence_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Scale+Up+and+Technology+Transfer%E2%80%94Downstream+Processes+Articles/Economic-Drivers-and-Trade-Offs-in-Antibody-Purifi/ArticleStandard/Article/detail/585667?contextCategoryId=39223&ref=25 The future of therapeutic MAbs lies in the development of economically feasible downstream processes. 2009-03-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/102009/585667null XML http://biopharminternational.findpharma.com/biopharm/Scale+Up+and+Technology+Transfer%E2%80%94Downstream+Processes+Articles/The-Development-and-Application-of-a-Monoclonal-An/ArticleStandard/Article/detail/585663?contextCategoryId=39223&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. 2009-03-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/102009/585663null XML http://biopharminternational.findpharma.com/biopharm/Scale+Up+and+Technology+Transfer%E2%80%94Downstream+Processes+Articles/Advances-in-Non-Protein-A-Purification-Processes-f/ArticleStandard/Article/detail/585664?contextCategoryId=39223&ref=25 In three non-affinity purification processes based on cation exchange capture with high binding capacity, applying a host cell protein exclusion strategy enabled robust scale up and better economics. 2009-03-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/102009/585664null XML http://biopharminternational.findpharma.com/biopharm/Scale+Up+and+Technology+Transfer%E2%80%94Downstream+Processes+Articles/Platform-Technology-for-Developing-Purification-Pr/ArticleStandard/Article/detail/585666?contextCategoryId=39223&ref=25 The future of therapeutic MAbs lies in the development of economically feasible downstream processes. 2009-03-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/102009/585666null XML http://biopharminternational.findpharma.com/biopharm/Scale+Up+and+Technology+Transfer%E2%80%94Downstream+Processes+Articles/Purification-Strategies-to-Process-5-gL-Titers-of-/ArticleStandard/Article/detail/585662?contextCategoryId=39223&ref=25 Altering the order of operations, using new resins, and increasing dynamic binding capacity can obviate the need for major facilty changes. 2009-03-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/102009/585662null XML http://biopharminternational.findpharma.com/biopharm/Scale+Up+and+Technology+Transfer%E2%80%94Downstream+Processes+Articles/A-Purification-Platform-for-the-Production-of-MAbs/ArticleStandard/Article/detail/585665?contextCategoryId=39223&ref=25 New techniques can greatly improve the MAb purification process. 2009-03-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/102009/585665null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing+Articles/Chromatography-Optimization-Strategy/ArticleStandard/Article/detail/585992?contextCategoryId=39223&ref=25 Robust packing procedures can improve process performance and increase resin lifetime. 2009-03-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/112009/585992/bp0309_chromatography_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Operations+Articles/Speed-and-Efficiency-in-Designing-and-Building-a-M/ArticleStandard/Article/detail/585551?contextCategoryId=39223&ref=25 A close-up look at Pfizer's biotherapeutics plant in Shanbally, Ireland. 2009-03-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/102009/585551/bp0309_Shanbally_Sept08_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing+Articles/Considerations-for-Scaling-up-Depth-Filtration-of-/ArticleStandard/Article/detail/585552?contextCategoryId=39223&ref=25 Data on the performance and variability of different formats. 2009-03-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/102009/585552/bp0309_depth_filtration_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Fermentation+%26+Cell+Culture+Articles/Upcoming-Technologies-to-Facilitate-More-Efficient/ArticleStandard/Article/detail/580777?contextCategoryId=39223&ref=25 Choosing the right tools to enhance the process. 2009-02-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/072009/580777/bp0209_biologic_manufacture_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Vaccine+Manufacturing+Articles/Advances-in-Single-Shot-Vaccine-Development/ArticleStandard/Article/detail/575565?contextCategoryId=39223&ref=25 The disadvantages of the traditional vaccine regime (prime plus boost) have spurred the development of single-shot vaccines. This article describes the development and manufacture of a prototype single-shot vaccine that uses microspheres made from cross-linked modified dextran polymers for controlled release of the antigen. 2009-01-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/032009/575565null XML http://biopharminternational.findpharma.com/biopharm/Disposables+Articles/An-Alternative-to-the-Scale-up-and-Distribution-of/ArticleStandard/Article/detail/575563?contextCategoryId=39223&ref=25 With virus-based production, vaccines can be available in 10-12 weeks. 2009-01-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/032009/575563/bp0109s_virus_like_particle_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Vaccine+Manufacturing+Articles/The-Therapeutic-Vaccine-Potential-of-MIS416-Adjuva/ArticleStandard/Article/detail/575564?contextCategoryId=39223&ref=25 This article discusses the potential of MIS416 adjuvant, a vaccine adjuvant and immunogen co-delivery system, to provide adequate immunostimulation to overcome host factors that may limit the success of therapeutic vaccines. 2009-01-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/032009/575564null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing+Articles/Protein-Peptide-Purification-using-the-Multicolumn/ArticleStandard/Article/detail/575127?contextCategoryId=39223&ref=25 A new method for MAb purification. 2009-01-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/032009/575127/bp0109_MCSGP_Process_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing+Articles/Antibody-Purification-Using-Membrane-Adsorbers/ArticleStandard/Article/detail/568936?contextCategoryId=39223&ref=25 Results from a process developed for a commercial antibody. 2008-12-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/492008/568936/antibody_purification_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Quality/Aggregates-in-MAbs-and-Recombinant-Therapeutic-Pro/ArticleStandard/Article/detail/566023?contextCategoryId=39223&ref=25 FDA perspectives on specs and effective control strategies. 2008-11-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566023/BP1108_MAb_aggregates_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Vaccine+Manufacturing+Articles/Bridging-the-Gap-in-Translational-Research-for-Vac/ArticleStandard/Article/detail/557307?contextCategoryId=39223&ref=25 Interview with Roger Lias, president and group commercial director at Eden Biodesign, Inc. 2008-10-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412008/557307null XML http://biopharminternational.findpharma.com/biopharm/Vaccine+Manufacturing+Articles/Vaccines-Incorporating-Toll-Like-Receptor-Ligands/ArticleStandard/Article/detail/557310?contextCategoryId=39223&ref=25 This article discusses the production process of the major influenza antigen, hemagglutinin (HA), by rDNA methods in E. coli. 2008-10-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412008/557310null XML http://biopharminternational.findpharma.com/biopharm/Vaccine+Manufacturing+Articles/Developing-and-Manufacturing-Attenuated-Live-Bacte/ArticleStandard/Article/detail/557306?contextCategoryId=39223&ref=25 There are a number of specific characteristics to be considered when developing and manufacturing live bacterial vaccines. 2008-10-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412008/557306null XML http://biopharminternational.findpharma.com/biopharm/Vaccine+Manufacturing+Articles/Preparedness-for-Pandemic-Flu-Outbreak/ArticleStandard/Article/detail/557308?contextCategoryId=39223&ref=25 To succeed in a pandemic, the industry must forge a preparedness plan to ensure adequate vaccines. 2008-10-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412008/557308/BP1008s_Pandemic_Prep_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Vaccine+Manufacturing+Articles/Developing-Plasmid-DNA-Vaccines/ArticleStandard/Article/detail/557309?contextCategoryId=39223&ref=25 Interview with Magda Marquet, co-CEO and co-president of Althea Technologies 2008-10-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412008/557309null XML http://biopharminternational.findpharma.com/biopharm/Vaccine+Manufacturing+Articles/Manufacturing-Process-Development-for-an-Epidermal/ArticleStandard/Article/detail/557900?contextCategoryId=39223&ref=25 The Center for Molecular Immunology (Havana, Cuba) has been working on a novel cancer immunotherapy targeting the epidermal growth factor (EGF). The vaccine is composed of a chemical conjugate of EGF and a carrier protein (rP64k), designed to trigger an anti-EGF antibody response. The results of studies of molecular characterization, immunogenic activity, and clinical data are presented here. 2008-10-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412008/557900null XML http://biopharminternational.findpharma.com/biopharm/Vaccine+Manufacturing+Articles/Formulation-Studies-of-an-Adsorbed-Conjugate-Vacci/ArticleStandard/Article/detail/557387?contextCategoryId=39223&ref=25 NeisVac-C is a polysaccharide-protein conjugate vaccine for use against Neisseria meningitidis serogroup C infection. The Phase 1 clinical formulation consisted of physiological saline, thimerosal, and aluminum hydroxide. The long-term stability data for both the PBS and saline formulations are presented in this article. 2008-10-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412008/557387null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing+Articles/Plasmid-DNA-Recovery-Using-Size-Exclusion-and-Perf/ArticleStandard/Article/detail/545359?contextCategoryId=39223&ref=25 Scalable method to recover plasmid-DNA. 2008-09-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/352008/545359/bp0908_Plasmid_DNA_Recovery_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Fermentation+%26+Cell+Culture+Articles/Viral-Clearance-Strategy-Using-a-Three-Tier-Orthog/ArticleStandard/Article/detail/545360?contextCategoryId=39223&ref=25 How to implement a risk-based approach to eliminating viruses. 2008-09-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/352008/545360/bp0908_Tarrach_ViralClearance_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Fermentation+%26+Cell+Culture+Articles/Modeling-of-Biopharmaceutical-Processes-Part-2-Pro/ArticleStandard/Article/detail/532052?contextCategoryId=39223&ref=25 A review of some recent contributions in process chromatography. 2008-08-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/312008/532052/Fermentation_cell_culture_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Improving-Tangential-Flow-Filtration-Yield/ArticleStandard/Article/detail/527448?contextCategoryId=39223&ref=25 Best methods to maximize product yield and membrane lifetime to enhance a tangential flow filtration process. 2008-07-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/272008/527448/TFF_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Upstream+Processing/Modeling-of-Biopharmaceutical-ProcessesmdashPart-1/ArticleStandard/Article/detail/522184?contextCategoryId=39223&ref=25 Process-modeling tools can ensure smooth tech transfer. 2008-06-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232008/522184/Fermentation_cell_culture_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Quality/Avoiding-the-Pain-of-Out-of-Specification-Results/ArticleStandard/Article/detail/522197?contextCategoryId=39223&ref=25 Improving your quality operations by using sound statistical principles. 2008-06-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232008/522197/OOS_results_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Impact-of-Lot-to-Lot-Variability-of-Cation-Exchang/ArticleStandard/Article/detail/513395?contextCategoryId=39223&ref=25 Understanding the impact on process performance. 2008-05-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182008/513395/0508_CEX_resin_variability_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/From+the+Editor/Straightforward-Guidance/ArticleStandard/Article/detail/512655?contextCategoryId=39223&ref=25 In the context of process validation, the confirmation of a belief must be checked repeatedly, throughout the product lifecycle. 2008-05-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182008/512655null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Harvest-and-Recovery-of-MAbs-from-Large-Scale-Mamm/ArticleStandard/Article/detail/513386?contextCategoryId=39223&ref=25 A comparison of primary harvest techniques. 2008-05-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182008/513386/0508_protein_purification_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Filter-Clogging-Issues-in-Sterile-Filtration/ArticleStandard/Article/detail/507480?contextCategoryId=39223&ref=25 A case study investigated the root cause of failures in sterile filtration by evaluating the effects and interactions of four operating parameters. 2008-04-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/142008/507480/0408_Rathore_Sterile_Filter_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Business/Book-Review-Biopharmaceutical-Products-in-the-US-a/ArticleStandard/Article/detail/509926?contextCategoryId=39223&ref=25 The book is a useful, comprehensive, and truly an excellent reference source of biopharmaceutical information. 2008-04-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/162008/509926null XML http://biopharminternational.findpharma.com/biopharm/Disposables+Advisor/Disposable-Bioreactors-The-Next-Generation/ArticleStandard/Article/detail/507470?contextCategoryId=39223&ref=25 Disposable technologies that mimic the conventional stainless-steel bioreactor will be most readily adopted 2008-04-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/142008/507470null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Economic-Drivers-and-Trade-Offs-in-Antibody-Purifi/ArticleStandard/Article/detail/499149?contextCategoryId=39223&ref=25 The future of therapeutic MAbs lies in the development of economically feasible downstream processes. 2008-03-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/092008/499149null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Purification-of-IgM-Monoclonal-Antibodies/ArticleStandard/Article/detail/499148?contextCategoryId=39223&ref=25 Manufacturing challenges surround the use of IgM monoclonal antibodies, but these can be overcome with current technology. 2008-03-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/092008/499148null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Optimizing-the-Primary-Recovery-Step-in-Nonaffinit/ArticleStandard/Article/detail/499143?contextCategoryId=39223&ref=25 An alternative approach to traditional Protein A schemes is comparable in overall efficiency, product recovery, and quality. 2008-03-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/092008/499143null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Process-Scale-Precipitation-of-Impurities-in-Mamma/ArticleStandard/Article/detail/499144?contextCategoryId=39223&ref=25 If certain engineering challenges can be addressed, precipitation may prove to be a valuable tool for antibody purification. 2008-03-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/092008/499144null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Solutions-for-Purification-of-Fc-fusion-Proteins/ArticleStandard/Article/detail/499145?contextCategoryId=39223&ref=25 When platform processes are applied to fusion molecules, innovation and flexibility are needed. 2008-03-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/092008/499145null XML http://biopharminternational.findpharma.com/biopharm/Emerging+Biotechs/Creating-Affordable-Vaccines-for-India/ArticleStandard/Article/detail/499136?contextCategoryId=39223&ref=25 How an electronics engineer led the first Indian company to carry out indigenous development of a recombinant vaccine. 2008-03-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/092008/499136null XML http://biopharminternational.findpharma.com/biopharm/Compliance+Notes/How-to-Ensure-Smooth-Technology-Transfer/ArticleStandard/Article/detail/499135?contextCategoryId=39223&ref=25 A comprehensive process and analytical transfer package can speed up your product's time to market and save costs. 2008-03-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/092008/499135null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Evaluation-of-Dendritic-Cell-Products-Generated-fo/ArticleStandard/Article/detail/499137?contextCategoryId=39223&ref=25 Emerging therapies pose challenges for standardizing QC. 2008-03-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/092008/499137/Whiteside_Dendritic_Cell_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Disposables/Extractables-and-Leachables-Study-Approach-for-Dis/ArticleStandard/Article/detail/490803?contextCategoryId=39223&ref=25 Two case studies illustrate a systematic approach. 2008-02-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/072008/490803/ding_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Disposables+Advisor/The-Disposables-Revolution/ArticleStandard/Article/detail/490807?contextCategoryId=39223&ref=25 The use of disposables has changed significantly in the biopharmaceutical industry. 2008-02-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/072008/490807null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Recombinant-Vaccine-Production-in-Yeast/ArticleStandard/Article/detail/485189?contextCategoryId=39223&ref=25 Human HBV can be grouped into eight genotypes, which differ by at least 8%. 2008-01-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/032008/485189null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/An-Improved-Manufacturing-Process-for-a-Recombinan/ArticleStandard/Article/detail/485190?contextCategoryId=39223&ref=25 The recombinant approach lends itself to the production of an inexpensive and effective vaccine at large scale. 2008-01-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/032008/485190null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Needle-Free-Methods-of-Vaccination/ArticleStandard/Article/detail/485192?contextCategoryId=39223&ref=25 Microstructured transdermal systems can deliver a vaccine in close proximity to the antigen-presenting cells in the epidermis. 2008-01-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/032008/485192null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Optimized-Vaccine-Development-and-Manufacturing-A-/ArticleStandard/Article/detail/485193?contextCategoryId=39223&ref=25 The replacement of a IgG ELISA assay with an SPR-based test can shorten the production workflow by one day. 2008-01-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/032008/485193null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Strategies-to-Improve-Vaccines-for-the-Neonate/ArticleStandard/Article/detail/485191?contextCategoryId=39223&ref=25 Potential interference with maternally-derived antibodies makes most vaccines less effective in the neonate. 2008-01-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/032008/485191null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Elements-of-QbD-in-Development-and-Scale-Up-of-Fre/ArticleStandard/Article/detail/481928?contextCategoryId=39223&ref=25 Design space concepts are key to a successful technology transfer. 2008-01-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/012008/481928/elements_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/012008/481928/Nail_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Outsourcing/Quality-by-Design-in-the-CMO-Environment/ArticleStandard/Article/detail/478714?contextCategoryId=39223&ref=25 How the authors used design of experiments and quality by design principles to develop a hydrophobic interaction chromatography step. 2007-12-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/502007/478714/qualitybydesign_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/502007/478714/Original[1]lr_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Increasing-Lyophilization-Productivity-Flexibility/ArticleStandard/Article/detail/477609?contextCategoryId=39223&ref=25 The second of a two part article. 2007-12-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/492007/477609/increasing_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/492007/477609/colorvials2_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Increasing-Lyophilization-Productivity-Flexibility/ArticleStandard/Article/detail/470170?contextCategoryId=39223&ref=25 2007-11-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/452007/470170/increasinglyph_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/452007/470170/colorvials2_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/From+the+Editor/The-Difficulty-of-Giving-Things-Up/ArticleStandard/Article/detail/470164?contextCategoryId=39223&ref=25 The challenge is not in coming up with a list of activities to discard, but in finding a feasible way to stop doing them. 2007-11-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/452007/470164null XML http://biopharminternational.findpharma.com/biopharm/News/MorphoSys-Granted-Fifth-US-Patent-for-its-Core-Ant/ArticleStandard/Article/detail/464000?contextCategoryId=39223&ref=25 The US Patent & Trademark Office has issued the fifth US patent to MorphoSys AG (Munich, Germany) stemming from MorphoSys’s base HuCAL (human combinatorial antibody library) patent family, providing extended protection to MorphoSys’s core technology. 2007-10-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412007/464000null HTML http://biopharminternational.findpharma.com/biopharm/News/European-Expert-Consortium-to-Develop-a-Novel-Pand/ArticleStandard/Article/detail/464007?contextCategoryId=39223&ref=25 Five European organizations, including three companies and two hospitals, have joined forces to develop a novel pandemic influenza vaccine as a potential emergency vaccination. 2007-10-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412007/464007null HTML http://biopharminternational.findpharma.com/biopharm/News/Sanofis-Adjuvant-Produces-a-High-Immune-Response-a/ArticleStandard/Article/detail/464005?contextCategoryId=39223&ref=25 Sanofi Pasteur (Lyon, France) has produced data showing that its new investigational H5N1 pandemic influenza vaccine containing a proprietary adjuvant achieved a high immune response at the lowest dose of H5N1 antigen reported to date. 2007-10-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412007/464005null HTML http://biopharminternational.findpharma.com/biopharm/News/Sanofi-Pasteur-Makes-Progress-with-Dengue-Vaccine/ArticleStandard/Article/detail/464006?contextCategoryId=39223&ref=25 Sanofi Pasteur (Lyon, France) has announced positive results from Phase 2 trials of its dengue vaccine candidate based on technology licensed from Acambis plc (Cambridge, UK). 2007-10-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412007/464006null HTML http://biopharminternational.findpharma.com/biopharm/News/Crucell-Discovers-MAbs-for-Protection-Against-H5N1/ArticleStandard/Article/detail/464008?contextCategoryId=39223&ref=25 Crucell N.V. (Leiden, the Netherlands) has discovered a set of human monoclonal antibodies (MAbs) that work to neutralize and protect against H5N1. 2007-10-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412007/464008null HTML http://biopharminternational.findpharma.com/biopharm/News/FDA-Approves-FluMists-Use-in-Young-Children/ArticleStandard/Article/detail/464009?contextCategoryId=39223&ref=25 The US Food and Drug Administration has approved the use of the nasal influenza vaccine FluMist in children ages 2?5. 2007-10-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412007/464009null HTML http://biopharminternational.findpharma.com/biopharm/News/FDA-Approves-New-Flu-Vaccine-Diversifying-the-US-S/ArticleStandard/Article/detail/463994?contextCategoryId=39223&ref=25 The approval of a new seasonal influenza vaccine has further diversified the supply to the US market. 2007-10-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412007/463994null HTML http://biopharminternational.findpharma.com/biopharm/GMPs%2FValidation/Protein-Therapeutics-and-the-Regulation-of-Quality/ArticleStandard/Article/detail/462759?contextCategoryId=39223&ref=25 Regulatory agencies have evolved along with the biotechnology industry to define quality standards. 2007-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/402007/462759/Page37_BP_t_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/402007/462759/Kozlowski_flash.gif XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Process-Chromatography-Five-Decades-of-Innovation/ArticleStandard/Article/detail/462761?contextCategoryId=39223&ref=25 Low-pressure process chromatography could not have developed without immense efforts to resolve scale-up issues in both column design and matrix stability. 2007-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/402007/462761/Page70_BP_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/402007/462761null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Glycosylation-and-the-Demands-of-Antibody-Engineer/ArticleStandard/Article/detail/462764?contextCategoryId=39223&ref=25 In one series of experiments, the glycosylation site of IgG1 was removed and an IgA glycosylation site was introduced—resulting in a total loss of biological function. 2007-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/402007/462764/Page126_BP_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/402007/462764null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Applications-of-MVDA-in-Biotech-Processing/ArticleStandard/Article/detail/462928?contextCategoryId=39223&ref=25 Multivariate data analysis can help biotech manufacturers deepen their process understanding. 2007-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/402007/462928/Page130_BP_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/402007/462928/COC079LHa_rev_flash.gif XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/The-Changing-Landscape-of-Global-Vaccine-Developme/ArticleStandard/Article/detail/462763?contextCategoryId=39223&ref=25 It is hoped that HIV patients' own immune responses can be strengthened by vaccines so they will not have to rely exclusively on antiretroviral drugs. 2007-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/402007/462763/Page115_BP_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/402007/462763null XML http://biopharminternational.findpharma.com/biopharm/Business/Final-Word-In-the-Quest-to-Manage-Capacity-Biology/ArticleStandard/Article/detail/451509?contextCategoryId=39223&ref=25 From the earliest days of the biotechnology industry, companies have grappled with the complexities of making innovative biopharmaceuticals on a large scale. Success in manufacturing begins with process science, since biotech production requires perfection in maintaining living organisms in a sterile environment under controlled physiological conditions. But unless companies can solve the challenge of planning for and managing manufacturing capacity, they will not be able to achieve the full potential of promising biotech products. 2007-09-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/342007/451509null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Lifetime-Studies-for-Membrane-Reuse-Principles-and/ArticleStandard/Article/detail/451555?contextCategoryId=39223&ref=25 2007-09-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/342007/451555/downstream_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/342007/451555/rathore_140_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/From+the+Editor/From-the-Editor-Issues-of-Scale/ArticleStandard/Article/detail/451502?contextCategoryId=39223&ref=25 In analyzing the industry's current challenges, let's be careful before extrapolating about what they mean. 2007-09-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/342007/451502null XML http://biopharminternational.findpharma.com/biopharm/Article/Cancer-Vaccines-Asymptotically-Approaching-Product/ArticleStandard/Article/detail/444993?contextCategoryId=39223&ref=25 For many cell-based vaccines, the precursor monocytes or CD34+ cells are cultured with cytokines to obtain dendritic cells, which are very potent antigen-presenting cells (APCs). 2007-08-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/312007/444993null XML http://biopharminternational.findpharma.com/biopharm/Article/Regulatory-Issues-Pandemic-Preparedness-Pacing-Up/ArticleStandard/Article/detail/444987?contextCategoryId=39223&ref=25 Any endpoint considered appropriate to support approval, whether a surrogate or a clinical endpoint, must be supported by substantial evidence of effectiveness. 2007-08-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/312007/444987null XML