http://biopharminternational.findpharma.com/biopharm/Upstream+Processing/Article/list/41918 Protein expression, fermentation & cell culture, and plant & animal expression methods, along with process development, scale up, and technology transfer for upstream steps. 2009-11-21T13:25:51Z http://biopharminternational.findpharma.com/biopharm/Fermentation+%26+Cell+Culture+Articles/Rapid-Process-Development-for-High-Yield-Plasmid-D/ArticleStandard/Article/detail/640112?contextCategoryId=41918&ref=25 How to reduce plasmid-mediated metabolic burden for higher yields. 2009-11-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/452009/640112null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing+Whitepapers/Analytical-Strategies-for-Monitoring-Residual-Impu/ArticleStandard/Article/detail/633766?contextCategoryId=41918&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/Trends/Fermentation-and-Cell-Culture/ArticleStandard/Article/detail/627745?contextCategoryId=41918&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/Quality/Analytical-Tools-for-Process-and-Product-Character/ArticleStandard/Article/detail/615148?contextCategoryId=41918&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/Protein+Expression+Articles/Avoiding-the-Regulatory-Catch-22/ArticleStandard/Article/detail/615146?contextCategoryId=41918&ref=25 Companies often wait for a critical mass before adopting new technologies. But if no one takes the risk, critical mass will never be reached. 2009-08-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/312009/615146null XML http://biopharminternational.findpharma.com/biopharm/Fermentation+%26+Cell+Culture+Articles/High-Cell-Density-Culture-to-Produce-Plasmid-DNA-f/ArticleStandard/Article/detail/608689?contextCategoryId=41918&ref=25 How to produce Plasmid DNA in a high-cell-density culture. 2009-07-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/272009/608689/bp0709_plasmid_DNA_culture_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Fermentation+%26+Cell+Culture+Articles/Site-Directed-Engineering-of-Defined-Chromosomal-S/ArticleStandard/Article/detail/608684?contextCategoryId=41918&ref=25 Method for integration of transgenes. 2009-07-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/272009/608684/bp0709_cell_engineering_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing+Articles/Using-Fluorescence--Based-Sensing-to-Accelerate-Pr/ArticleStandard/Article/detail/601409?contextCategoryId=41918&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/Fermentation+%26+Cell+Culture+Articles/Versatility-of-a-Single-Use-Bioreactor-Platform-fo/ArticleStandard/Article/detail/580776?contextCategoryId=41918&ref=25 Are disposable bioreactors effective for cell culture? 2009-02-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/072009/580776/bp0209_single_use_bioreactor_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Fermentation+%26+Cell+Culture+Articles/Upcoming-Technologies-to-Facilitate-More-Efficient/ArticleStandard/Article/detail/580777?contextCategoryId=41918&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/Expansion+%26+Management+Articles/Biomanufacturing-Capacity-Quandary/ArticleStandard/Article/detail/566019?contextCategoryId=41918&ref=25 There could be a serious glut of commercial scale mammalian cell culture capacity over the next five years. Then again, there could be a significant shortage. It all depends on how things develop in expression technology, the new product pipeline, and corporate strategies. 2008-11-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566019null XML http://biopharminternational.findpharma.com/biopharm/Protein+Expression+Articles/Detection-of-Cache-Valley-Virus-in-Biologics-Manuf/ArticleStandard/Article/detail/557250?contextCategoryId=41918&ref=25 Avoid manufacturing failures by effective viral inactivation. 2008-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412008/557250/bp1008_Nims_Vero_Cells_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=41918&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=41918&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/Upstream+Processing/Recombinant-Protein-Production-Yields-from-Mammali/ArticleStandard/Article/detail/522161?contextCategoryId=41918&ref=25 A discussion of past achievements and future expectations of recombinant protein production yields from mammalian cells. 2008-06-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232008/522161null XML http://biopharminternational.findpharma.com/biopharm/Upstream+Processing/Maximizing-Yields-of-Plasmid-DNA-Processes/ArticleStandard/Article/detail/522163?contextCategoryId=41918&ref=25 Recombinant protein and plasmid DNA production using microbial expression systems is the cornerstone of many biologics manufacturing processes. HCD methods are commonly used for these processes because of the advantages they provide. 2008-06-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232008/522163null XML http://biopharminternational.findpharma.com/biopharm/Upstream+Processing/The-Role-of-Media-Development-in-Process-Optimizat/ArticleStandard/Article/detail/522165?contextCategoryId=41918&ref=25 With a variety of recombinant, animal-free, defined protein supplements such as growth factors, transferrin, and albumin entering the market, the biopharmaceutical industry now has innovative and safer alternatives to serum and other animal-derived supplements. 2008-06-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232008/522165null XML http://biopharminternational.findpharma.com/biopharm/Upstream+Processing/Fusion-Tags-for-Protein-Expression-and-Purificatio/ArticleStandard/Article/detail/522166?contextCategoryId=41918&ref=25 Gene fusion tags can improve the yield and solubility of many recombinant proteins. This article discusses the most popular fusion tags and the proteases used to remove them, with special reference to recently introduced technologies. 2008-06-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232008/522166null XML http://biopharminternational.findpharma.com/biopharm/Upstream+Processing/Improving-Protein-Production-in-CHO-Cells/ArticleStandard/Article/detail/522164?contextCategoryId=41918&ref=25 Using chemically defined feeds with CHO cell lines not only eliminates the variability associated with using plant hydrolysates, but could also improve the productivity of biopharmaceutical protein manufacture and help move therapeutic proteins into clinical trials more rapidly. 2008-06-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232008/522164null XML http://biopharminternational.findpharma.com/biopharm/Upstream+Processing/Modeling-of-Biopharmaceutical-ProcessesmdashPart-1/ArticleStandard/Article/detail/522184?contextCategoryId=41918&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/From+the+Editor/Straightforward-Guidance/ArticleStandard/Article/detail/512655?contextCategoryId=41918&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=41918&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/Upstream+Processing/Leveraging-Fermentation-Heat-Transfer-Data-to-Bett/ArticleStandard/Article/detail/507474?contextCategoryId=41918&ref=25 A simple method to leverage fermentation heat transfer data. 2008-04-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/142008/507474/0408_Berge_Fermenter_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Disposables+Advisor/Disposable-Bioreactors-The-Next-Generation/ArticleStandard/Article/detail/507470?contextCategoryId=41918&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/Compliance+Notes/How-to-Ensure-Smooth-Technology-Transfer/ArticleStandard/Article/detail/499135?contextCategoryId=41918&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/Disposables/Extractables-and-Leachables-Study-Approach-for-Dis/ArticleStandard/Article/detail/490803?contextCategoryId=41918&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=41918&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/Upstream+Processing/Rapid-Development-and-Optimization-of-Cell-Culture/ArticleStandard/Article/detail/481930?contextCategoryId=41918&ref=25 Chinese hamster ovary (CHO) cells are used extensively in the biopharmaceutical industry to produce recombinant proteins that require post-translation modification for full biological functionality. Optimization of culture conditions for recombinant CHO cell lines presents challenges in light of the diverse nutritional requirements observed with different clonally derived cell lines. 2008-01-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/012008/481930/rapid_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/012008/481930null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Elements-of-QbD-in-Development-and-Scale-Up-of-Fre/ArticleStandard/Article/detail/481928?contextCategoryId=41918&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/Upstream+Processing/Engineering-Biopharmaceuticals/ArticleStandard/Article/detail/470171?contextCategoryId=41918&ref=25 An overall increasing proportion of future product approvals will be engineered in some way, either directly or indirectly. 2007-11-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/452007/470171/engineeringbio_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/452007/470171/protein1_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/News/SAFC-Expands-Fermentation-Capabilities-with-Upgrad/ArticleStandard/Article/detail/463999?contextCategoryId=41918&ref=25 SAFC (St. Louis, MO), a member of the Sigma-Aldrich Group, has announced a $29-million investment to significantly expand its drug substance capabilities in high-potency biologics at the Sigma-Aldrich facility in Jerusalem, Israel 2007-10-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412007/463999null HTML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Glycosylation-and-the-Demands-of-Antibody-Engineer/ArticleStandard/Article/detail/462764?contextCategoryId=41918&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/Business/Biotech-Manufacturing-Grows-Up/ArticleStandard/Article/detail/462765?contextCategoryId=41918&ref=25 It became a strategic imperative to find a better, more efficient way to manufacture our products. To continue with the status quo was untenable. 2007-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/402007/462765/Page159_BP_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/402007/462765null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Applications-of-MVDA-in-Biotech-Processing/ArticleStandard/Article/detail/462928?contextCategoryId=41918&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/Upstream+Processing/The-Evolution-of-Protein-Expression-and-Cell-Cultu/ArticleStandard/Article/detail/462760?contextCategoryId=41918&ref=25 It is commonly believed that technologies in the next 10–15 years will enable sequencing an individualized human genome for less than $1,000. With innovations like these, the twenty-first century will certainly belong to biotechnology. From an industrial standpoint, the discovery of therapeutic molecules and the development of cell lines and processes to produce these molecules will be of paramount importance. This article describes various approaches that have been prevalent in the industry or are likely to be used in the future for generating cell lines with desirable traits and developing high titer cell culture processes. 2007-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/402007/462760/Page56_BP_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/402007/462760null XML http://biopharminternational.findpharma.com/biopharm/Business/On-the-Biotechnology-Frontier-Personalized-Medicin/ArticleStandard/Article/detail/462868?contextCategoryId=41918&ref=25 Favrille, a San Diego-based biopharmaceutical company, is one of a handful of firms on the forefront of personalized medicine. Because personalized treatment is tailored to an individual's biology, it has the potential to be far more effective than current approaches to disease management. 2007-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/402007/462868/Page154_BP_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/402007/462868null XML http://biopharminternational.findpharma.com/biopharm/GMPs%2FValidation/Protein-Therapeutics-and-the-Regulation-of-Quality/ArticleStandard/Article/detail/462759?contextCategoryId=41918&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/Business/Final-Word-In-the-Quest-to-Manage-Capacity-Biology/ArticleStandard/Article/detail/451509?contextCategoryId=41918&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/From+the+Editor/From-the-Editor-Issues-of-Scale/ArticleStandard/Article/detail/451502?contextCategoryId=41918&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/Upstream+Processing/Biopharmecuticals-Approval-Trends-in-2006/ArticleStandard/Article/detail/451508?contextCategoryId=41918&ref=25 There were notable approvals in nonparenteral delivery systems and biosimiliars in 2006. 2007-09-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/342007/451508/productdevelopment_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/342007/451508/walsh_140_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/News/SemBioSys-Produces-Commercial-Levels-of-Recombinan/ArticleStandard/Article/detail/451114?contextCategoryId=41918&ref=25 SemBioSys Genetics, Inc. (Calgary, Canada, www.sembiosys.com) announced that it has successfully produced commercial levels of apolipoprotein AI and its variant apolipoprotein AI(Milano), collectively referred to as Apo AI, in safflower seed lines. 2007-08-21T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/342007/451114null HTML http://biopharminternational.findpharma.com/biopharm/Article/Manufacturing-Vaccines-in-Adherent-Cell-Lines-Usin/ArticleStandard/Article/detail/444994?contextCategoryId=41918&ref=25 The recent growth in the vaccine market has led to renewed interest in using adherent human cell lines for vaccine production. Traditionally, small-scale adherent cell line production has been carried out in roller bottles or T-flasks. Over the past few years, however, a number of companies have found multi-tray disposable bioreactors an effective method for producing high-quality drug products using adherent cells. These disposable, expandable systems have also facilitated scale up from laboratory to clinical-scale. 2007-08-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/312007/444994null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/New-Age-Vaccine-Adjuvants-Friend-or-Foe/ArticleStandard/Article/detail/444996?contextCategoryId=41918&ref=25 Adjuvant-caused vaccine reactions are one of the most important barriers to better acceptance of routine prophylactic vaccination. 2007-08-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/312007/444996null XML http://biopharminternational.findpharma.com/biopharm/Article/Plasmid-DNAndashBased-Vaccines-Combating-Infectiou/ArticleStandard/Article/detail/444992?contextCategoryId=41918&ref=25 Like the egg-based vaccine production process, producing a vaccine under cGMP conditions using mammalian cells can be a lengthy process, taking a minimum of six to 12 months. 2007-08-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/312007/444992null XML http://biopharminternational.findpharma.com/biopharm/Article/The-Adjuvant-Patch-A-Universal-Dose-Sparing-Approa/ArticleStandard/Article/detail/444989?contextCategoryId=41918&ref=25 In animal studies, we have demonstrated that the dose of an injected H5N1 vaccine candidate can be significantly reduced by using a skin patch containing E. coli heat-labile enterotoxin (LT) applied over the injection site. LT-activated epidermal Langerhans cells migrate to the nearby draining lymph node and enhance the immune response to the injected antigen. A dry patch formulation has been optimized as a dose sparing strategy for pandemic flu and other vaccines. Iomai Corporation has developed a proprietary stabilizing formulation for the patch that allows use and storage at ambient temperature. The patch withstands temperature extremes during shipment, and is suitable for stockpiling. 2007-08-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/312007/444989null XML http://biopharminternational.findpharma.com/biopharm/Article/Cell-CulturendashBased-Manufacturing-Meeting-the-C/ArticleStandard/Article/detail/444991?contextCategoryId=41918&ref=25 Vaccines against strains originating from avian flu may achieve poor yields in egg-based systems. Consequently, both public and private interest in alternative systems is high. 2007-08-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/312007/444991null XML http://biopharminternational.findpharma.com/biopharm/Article/Regulatory-Issues-Pandemic-Preparedness-Pacing-Up/ArticleStandard/Article/detail/444987?contextCategoryId=41918&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 http://biopharminternational.findpharma.com/biopharm/Article/Pandemic-Flu-Preparedness-A-Manufacturing-Perspect/ArticleStandard/Article/detail/444990?contextCategoryId=41918&ref=25 For pandemic vaccine processing, single-use filter cartridges and membrane chromatography technologies could offer significant time- and cost-reduction advantages. 2007-08-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/312007/444990null XML http://biopharminternational.findpharma.com/biopharm/Article/Cancer-Vaccines-Asymptotically-Approaching-Product/ArticleStandard/Article/detail/444993?contextCategoryId=41918&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/Upstream-Processing-Regulatory-Considerations-Rega/ArticleStandard/Article/detail/439560?contextCategoryId=41918&ref=25 2007-07-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/272007/439560/upstream_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/272007/439560null XML http://biopharminternational.findpharma.com/biopharm/Article/Vendor-Notes-The-Biovest-AutovaxID-Enabling-the-Pr/ArticleStandard/Article/detail/439426?contextCategoryId=41918&ref=25 The AutovaxID is a self-contained, completely enclosed, fully automated hollow fiber bioreactor that permits rapid, efficient scale up of patient-derived cells. It is based on hollow fiber bioreactor technology and is an ideal system for high-density cell culture and the production of monoclonal antibodies or other therapeutic proteins. 2007-07-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/272007/439426/vendornotesbiovest_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/272007/439426null XML http://biopharminternational.findpharma.com/biopharm/Article/Process-Development-Maximizing-Process-Data-from-D/ArticleStandard/Article/detail/439424?contextCategoryId=41918&ref=25 Process development and manufacturing for biopharmaceuticals are often disjointed activities. Disconnects among groups are aggravated by a lack of common terminology and poor data management practices. A UK biotech consortium has initiated a collaborative development effort to address data management issues. The proposed outcome is a data model, based on the ISA-88 Standard for Batch Control, to capture process and facility data throughout the product lifecycle. A data framework that follows the ISA-88 model can simplify process scale up and enable early views of project costs and facility fit. 2007-07-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/272007/439424/maximizing_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/272007/439424null XML http://biopharminternational.findpharma.com/biopharm/Upstream+Processing/FDA-Finalizes-Guidances-For-Pandemic-and-Seasonal-/ArticleStandard/Article/detail/436169?contextCategoryId=41918&ref=25 The US Food and Drug Administration (FDA, Rockville, MD, www.fda.gov) has issued final recommendations for increasing the supply of safe and effective influenza vaccines for both seasonal and pandemic use. 2007-06-21T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/252007/436169null HTML http://biopharminternational.findpharma.com/biopharm/News/Viragen-Reports-Protein-Expression-Breakthrough-in/ArticleStandard/Article/detail/428427?contextCategoryId=41918&ref=25 Viragen, Inc. (Plantation, FL, www.viragen.com), and its collaborative partners in the field of avian transgenics—Roslin Institute (Scotland, UK, www.roslin.ac.uk) and (Oxford, UK, www.oxfordbiomedica.co.uk)—have announced a significant breakthrough in the development of the OVA system, an avian transgenic protein expression technology. 2007-05-23T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/212007/428427null HTML http://biopharminternational.findpharma.com/biopharm/Article/Rapid-High-Throughput-Feed-Optimization/ArticleStandard/Article/detail/423194?contextCategoryId=41918&ref=25 Growth of CHO cell cultures in a shaker plate model system was demonstrated to be comparable to growth in shake flasks. 2007-05-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182007/423194null XML http://biopharminternational.findpharma.com/biopharm/Article/Applying-Fusion-Protein-Technology-to-E-coli/ArticleStandard/Article/detail/423193?contextCategoryId=41918&ref=25 Protein expression remains an arduous task that involves a complex decision tree. Establishing tools and optimal conditions for each protein remains an empirical exercise. 2007-05-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182007/423193null XML http://biopharminternational.findpharma.com/biopharm/Article/Advances-in-Animal-Free-Manufacturing-of-Biopharma/ArticleStandard/Article/detail/423195?contextCategoryId=41918&ref=25 In addition to existing guidance, in January 2007 the FDA announced further proposals to prohibit the use of certain bovine materials as ingredients in some medical products or as elements of product manufacturing. 2007-05-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182007/423195null XML http://biopharminternational.findpharma.com/biopharm/Article/Disposable-Bioreactors-Based-on-Wave-Agitation-Tec/ArticleStandard/Article/detail/423196?contextCategoryId=41918&ref=25 Energy input is affected by rocking the chamber back and forth, generating a fluid movement in the cell culture and medium. 2007-05-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182007/423196null XML http://biopharminternational.findpharma.com/biopharm/Article/From-the-Editor-Score-One-for-Preparedness/ArticleStandard/Article/detail/423185?contextCategoryId=41918&ref=25 Fortunately for all of us, not everyone's head is in the sand. 2007-05-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182007/423185null XML http://biopharminternational.findpharma.com/biopharm/News/Companies-Share-CHO-Genomic-Sequences-to-Improve-D/ArticleStandard/Article/detail/421522?contextCategoryId=41918&ref=25 Major pharmaceutical and biotechnology companies have joined forces under the auspices of the Society for Biological Engineering (SBE, New York, NY, www.aiche.org/SBE) to make use of cell line research that is expected to increase the efficiencies of drug development. 2007-04-22T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/172007/421522null HTML http://biopharminternational.findpharma.com/biopharm/News/Pandemic-Preparedness-Picks-Up-Pace-with-First-Flu/ArticleStandard/Article/detail/421523?contextCategoryId=41918&ref=25 The FDA's (Rockville, MD, www.fda.gov) first approval in the United States of a vaccine for humans against the H5N1 influenza virus marks an important step forward in protecting the public against a pandemic influenza outbreak. 2007-04-22T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/172007/421523null HTML http://biopharminternational.findpharma.com/biopharm/Article/The-Importance-of-Project-Management/ArticleStandard/Article/detail/416133?contextCategoryId=41918&ref=25 Are the deadlines for your outsourced projects often not met? Are you unsure of the status of your project at any given time? Is the original budget of your study typically exceeded? 2007-04-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/142007/416133null XML http://biopharminternational.findpharma.com/biopharm/Article/Disposables-Keeping-Pace-with-Todays-Disposable-Pr/ArticleStandard/Article/detail/415834?contextCategoryId=41918&ref=25 Frequently asked questions on implementing and using single-use technologies 2007-04-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/142007/415834/disposables_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/142007/415834null XML http://biopharminternational.findpharma.com/biopharm/Article/China-Today-Vaccine-Development-in-China/ArticleStandard/Article/detail/415831?contextCategoryId=41918&ref=25 The Chinese vaccine market competition is now transferring from the former price-competition model to a technology- competition model. 2007-04-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/142007/415831null XML http://biopharminternational.findpharma.com/biopharm/News/CTI-Forms-Aequus-to-Develop-Alternative-to-PEGylat/ArticleStandard/Article/detail/413460?contextCategoryId=41918&ref=25 Cell Therapeutics, Inc. (CTI, Seattle, WA, www.ctiseattle.com), has formed a new spin-off company, Aequus BioPharma, Inc., to develop a novel process to extend the half-life of proteins. 2007-03-22T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/122007/413460null HTML http://biopharminternational.findpharma.com/biopharm/News/Hylenex-Accelerates-Time-to-Peak-Blood-Concentrati/ArticleStandard/Article/detail/413461?contextCategoryId=41918&ref=25 Patients receiving palliative care in hospices, hospitals, and other settings can benefit from a subcutaneous injection of morphine with Hylenex recombinant (hyaluronidase human injection). 2007-03-22T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/122007/413461null HTML http://biopharminternational.findpharma.com/biopharm/Article/Upstream-ProcessingVendor-Notes-Generating-Stable-/ArticleStandard/Article/detail/407875?contextCategoryId=41918&ref=25 Manufacturing recombinant proteins at industrially relevant levels requires technologies that can engineer stable, high-expressing cell lines rapidly, reproducibly, and with relative ease. Commonly used methods incorporate transfection of mammalian cell lines with plasmid DNA containing the gene of interest. Identifying stable, high-expressing transfectants is normally laborious and time consuming. To improve this process, the ACE System has been developed based on pre-engineered artificial chromosomes with multiple recombination acceptor sites. This system allows targeted integration of single or multiple gene copies and eliminates the need for random integration into native host chromosomes. To illustrate the usefulness of the ACE System in generating stable, high-expressing cell lines, we present several case studies covering CHO cell lines expressing monoclonal antibodies. 2007-03-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/092007/407875/45_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/092007/407875null XML http://biopharminternational.findpharma.com/biopharm/Fermentation+%26+Cell+Culture+Articles/Outstourcing-Insights-Ferment-in-Biomanufacturing/ArticleStandard/Article/detail/407872?contextCategoryId=41918&ref=25 The three largest players have accumulated, or are in the process of accumulating, nearly a million liters of capacity between them. 2007-03-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/092007/407872null XML http://biopharminternational.findpharma.com/biopharm/Article/Disposable-Biopharmaceutical-ProcessesndashMyth-or/ArticleStandard/Article/detail/423540?contextCategoryId=41918&ref=25 Biopharmaceutical processes typically require a significant investment in equipment—often a substantial obstacle for start-up companies. The risk of drug development failure is often high, further limiting access to the required capital. Flexibility and lower capital outlays are required not only by start-up companies, but also by research organizations with multiple product lines and by companies requiring quick capacity increases. Disposable technologies offer the highest potential for these companies to meet their business requirements. With lower capital requirements and increased flexibility, disposables are an important part of these companies' risk management strategy. 2006-11-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182007/423540null XML http://biopharminternational.findpharma.com/biopharm/Article/Technology-Transfer-How-to-Make-It-a-Competitive-A/ArticleStandard/Article/detail/390957?contextCategoryId=41918&ref=25 If a company wants to reduce costs, it should consider outsourcing some manufacturing and analytical testing to low-cost sites. 2006-11-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/492006/390957/TN_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/492006/390957null XML http://biopharminternational.findpharma.com/biopharm/Article/Production-Cost-Analysis-Economic-Analysis-as-a-to/ArticleStandard/Article/detail/391532?contextCategoryId=41918&ref=25 The number of biotechnology-based human therapeutic products in the late-stage pipeline, and the average cost to commercialize a biotech product, have steadily increased. This has required biotech companies to use economic analysis as a tool during process development and for making decisions about process design. Process development efforts now aim to create processes that are economical, as well as optimal and robust. 2006-11-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/502006/391532/TN_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/502006/391532null XML http://biopharminternational.findpharma.com/biopharm/Article/Successful-Technology-Transfer-Requires-More-Than-/ArticleStandard/Article/detail/377759?contextCategoryId=41918&ref=25 We often assume we know what success looks like for our partner, but we never ask them, or take the time to write it down. 2006-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412006/377759/Tn_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412006/377759null XML http://biopharminternational.findpharma.com/biopharm/Article/Expediting-the-Technical-Transfer-of-Biopharmaceut/ArticleStandard/Article/detail/371022?contextCategoryId=41918&ref=25 Established, fully validated methodology and SOPs are required prior to initiation of any training activities. 2006-09-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/372006/371022/TN_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/372006/371022null XML http://biopharminternational.findpharma.com/biopharm/Article/Writing-Effective-Development-Reports/ArticleStandard/Article/detail/371021?contextCategoryId=41918&ref=25 Development reports document process development and support the design of validation experiments, yet in many firms training is not provided nor are expectations established. This article describes how project managers can help scientists master the art of report-writing. 2006-09-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/372006/371021/TN_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/372006/371021null XML http://biopharminternational.findpharma.com/biopharm/Upstream+Processing/Designing-a-Shorter-Vertical-Leg-for-Sanitary-Stea/ArticleStandard/Article/detail/371600?contextCategoryId=41918&ref=25 Steam traps are part of a steam-in-place system. The current design allots 18 in. of vertical leg for condensate backup. A design with a sensitive bellows has been proven in laboratory tests to need only 6 in. of vertical leg during the 15 min. of 121?C sterilization. Loads of 1 to 27 lb/h are covered by the capability of the new trap, equivalent to required steam for vessels 20 to 40,000 L. 2006-09-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/372006/371600/TN_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/372006/371600null XML http://biopharminternational.findpharma.com/biopharm/Article/Successful-Bioreactor-Installation-What-it-Takes/ArticleStandard/Article/detail/361017?contextCategoryId=41918&ref=25 Understand your company's requirements, define responsibilities,and manage your team effectively. 2006-08-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/302006/361017null XML http://biopharminternational.findpharma.com/biopharm/Article/Production-of-Recombinant-Therapeutic-Proteins-in-/ArticleStandard/Article/detail/362005?contextCategoryId=41918&ref=25 Capital investments in production plants represent a significant portion of the cost of new recombinant drugs 2006-08-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/312006/362005null XML http://biopharminternational.findpharma.com/biopharm/Article/Disposables-A-Solution-for-Efficient-Biopharmaceut/ArticleStandard/Article/detail/353133?contextCategoryId=41918&ref=25 Disposables require less space than conventional equipment, and they can be assembled offsite into complete process trains. 2006-07-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/262006/353133null XML http://biopharminternational.findpharma.com/biopharm/Article/From-the-Editor-in-Chief-A-Shot-In-The-Arm/ArticleStandard/Article/detail/353125?contextCategoryId=41918&ref=25 The approvals of two groundbreaking vaccines in the last month is encouraging news. Vaccines have long been undervalued because they haven't been as profitable as other pharmaceuticals. So it's good to see them getting deserved attention that goes beyond fears of flu outbreaks. 2006-07-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/262006/353125null XML http://biopharminternational.findpharma.com/biopharm/News/Promise-and-Challenges-of-Biotech-Vaccines/ArticleStandard/Article/detail/340416?contextCategoryId=41918&ref=25 Several recent approvals highlight progress in developing both prophylactic and therapeutic vaccines. 2006-06-27T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/262006/340416null HTML http://biopharminternational.findpharma.com/biopharm/News/Iontophoresis-Sonophoresis-and-Microneedles-Permit/ArticleStandard/Article/detail/340417?contextCategoryId=41918&ref=25 The transdermal delivery of biologics-as well as of conventional drugs-is growing in popularity because the technique offers numerous advantages. 2006-06-27T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/262006/340417null HTML http://biopharminternational.findpharma.com/biopharm/News/Linking-Manufacturing-Specifications-to-Clinical-R/ArticleStandard/Article/detail/340410?contextCategoryId=41918&ref=25 "Clinical data is the gold standard" for setting manufacturing specifications, said Patrick Swann, PhD, acting deputy director of the Division of Monoclonal Antibodies at FDA, at a session on specification setting at the AAPS National Biotechnology Conference that was held June 19-21 in Boston. 2006-06-27T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/262006/340410null HTML http://biopharminternational.findpharma.com/biopharm/Article/From-the-Editor-in-Chief-When-Does-Glycosylation-M/ArticleStandard/Article/detail/329354?contextCategoryId=41918&ref=25 The belief that glycosylation is critical to ensuring the functionality of protein therapeutics—and preventing immunogenicity—drives many manufacturing decisions. But is it time to question this industry tenet? 2006-06-01T04:00:00Z XML http://biopharminternational.findpharma.com/biopharm/Separation+%26+Purification+Articles/Producing-Proteins-Using-Transgenic-Oilbody-Oleosi/ArticleStandard/Article/detail/329358?contextCategoryId=41918&ref=25 Transgenics can substantially reduce capital investment and lower production costs through economies of scale and more flexible scale-up. 2006-06-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/212006/329358/Tn_thumbnail.jpg XML http://biopharminternational.findpharma.com/biopharm/News/Accept-No-Limits-on-Mammalian-Cell-Expression/ArticleStandard/Article/detail/321953?contextCategoryId=41918&ref=25 Instead of investing in new facilities, the industry should focus on improving manufacturing technology to increase yields, says Timothy Charlebois, PhD, director of cell and molecular sciences for Wyeth (Madison, NJ, www.wyeth.com). Charlebois made these remarks in his introduction to the session, "Frontiers and Economics of Mammalian Cell Expression," at the BIO 2006 convention."I've seen examples where we took a process that produced 3 grams of protein per liter, and were able to optimize it so that it produced 9.6 g/L," he said, adding that future yields are likely to be above 10 g/L. 2006-05-01T04:00:00Z XML http://biopharminternational.findpharma.com/biopharm/Article/StreetTalk-Investments-in-Avian-Flu-Soar/ArticleStandard/Article/detail/321954?contextCategoryId=41918&ref=25 The federal government plans to spend $3.3 billion on bird flu initiatives, about half of that on a vaccine. 2006-05-01T04:00:00Z XML http://biopharminternational.findpharma.com/biopharm/Article/From-the-Editor-in-Chief-Engineering-Oneself-Out-o/ArticleStandard/Article/detail/321951?contextCategoryId=41918&ref=25 Alexander Fleming's original process for making penicillin was a low-volume, and presumably, labor-intensive affair. Today, it is a highly optimized, low-budget operation that is carried out only overseas. In other words, says Wei-Shou Hu, PhD, of the University of Minnesota, we engineered ourselves out of a job. Could we do the same with mammalian cell culture? Hu posed this question during a presentation at the BIO conference in April. 2006-05-01T04:00:00Z XML http://biopharminternational.findpharma.com/biopharm/Article/Maximizing-Protein-Expression-in-Filamentous-Fungi/ArticleStandard/Article/detail/321958?contextCategoryId=41918&ref=25 One of the major challenges in fungal biotechnology is preventing proteases of the fungi from degrading recombinant proteins. 2006-05-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/172006/321958/TN_thumbnail.jpg XML http://biopharminternational.findpharma.com/biopharm/Article/Final-Word-Creative-Solutions-Can-Ensure-Pandemic-/ArticleStandard/Article/detail/321961?contextCategoryId=41918&ref=25 Certain areas of the vaccine market appear to be in vogue again, revitalized by blockbusters such as Prevnar, the pneumococcal pneumonia vaccine that reaped $1.5 billion in sales last year, and the human papilloma virus vaccines, which are projected to reach $4 billion per year. 2006-05-01T04:00:00Z XML http://biopharminternational.findpharma.com/biopharm/Article/Introduction/ArticleStandard/Article/detail/312956?contextCategoryId=41918&ref=25 Anyone who has ever hoisted a glass of a local microbrew has experienced the results of the oldest form of biotechnology?fermentation, the process by which living cells obtain energy through the breakdown of glucose and other molecules. The basic technique of brewing has not changed much in the past 6,000 years, but it is still an excellent illustration of the principles that underlie some of today's most sophisticated biotech production. 2006-03-10T05:00:00Z XML http://biopharminternational.findpharma.com/biopharm/Article/The-Processes/ArticleStandard/Article/detail/312959?contextCategoryId=41918&ref=25 Fermentation is an industrial process, but it's probably easier to understand it as something more familiar: raising a living creature. Every fermentation process has to answer several basic questions: Where will the cells live and grow? What will they nourish themselves with? Will the cells live suspended in a mix of water and nutrients (the medium) or do they need to be contained or allowed to attach themselves to a solid base? How will food and air be distributed so all the individual cells get their share? Should all the nutrients the cells need be added at one time, or should the cells be fed additional food as fermentation progresses? How will the progress of fermentation be monitored to ensure the best possible results? 2006-03-10T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/112006/312959/t2_thumbnail.jpg XML http://biopharminternational.findpharma.com/biopharm/Article/References-and-Resources/ArticleStandard/Article/detail/312963?contextCategoryId=41918&ref=25 To learn more about the processes of fermentation and cell culture used in the production of biopharmaceuticals, you can refer to our advertisers or to the following publications, organizations, and web sites. 2006-03-10T05:00:00Z XML http://biopharminternational.findpharma.com/biopharm/Article/The-Science/ArticleStandard/Article/detail/312957?contextCategoryId=41918&ref=25 At the heart of modern biotechnology is the ability to manipulate DNA, the astonishing molecule that contains the genetic code of all life on earth. But fermentation and cell culture are also the practical art of keeping cells alive and growing in an artificial environment. As a result, the science of cell culture also includes a healthy focus on the natural processes that keep cells alive. 2006-03-10T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/112006/312957/t1_thumbnail.jpg XML http://biopharminternational.findpharma.com/biopharm/Article/Glossary/ArticleStandard/Article/detail/312962?contextCategoryId=41918&ref=25 Many of these terms have more general definitions as well. Those given here are specific to their application in cell culture and fermentation. 2006-03-10T05:00:00Z XML http://biopharminternational.findpharma.com/biopharm/Fermentation+%26+Cell+Culture+Articles/The-Applications/ArticleStandard/Article/detail/312960?contextCategoryId=41918&ref=25 As we've shown, biopharmaceutical companies have many options when they choose an expression system: bacteria, yeasts, insect or mammalian cells, and transgenics. Each system has its advantages and disadvantages. Company decision makers must ask themselves several important questions: How much product must be made? How complex is the molecule? Does it require posttranslational modifications to be biologically active? The expression system determines what kind of contaminants will be present and in what quantities. It also determines economic factors: the time scales involved, expression levels obtained, and various regulatory issues. Each potential expression system must be evaluated for its ability to produce economically the maximum amount of biologically active product. Purification methods may be different for products that come from the different host systems. And regulators are more familiar with some systems than with others. 2006-03-10T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/112006/312960/t3_thumbnail.jpg XML http://biopharminternational.findpharma.com/biopharm/Article/Automated-Process-Control-for-the-Development-Labo/ArticleStandard/Article/detail/312954?contextCategoryId=41918&ref=25 Minimum disruption and maximum gain result when adopting a distributed process control and data management system for a cell culture and fermentation lab. 2006-03-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/112006/312954/TN_thumbnail.jpg XML http://biopharminternational.findpharma.com/biopharm/Article/Expression-of-Recombinant-Proteins-in-Yeast/ArticleStandard/Article/detail/301979?contextCategoryId=41918&ref=25 Yeast systems have been a staple for producing large amounts of proteins for industrial and biopharmaceutical use for many years. Yeast can be grown to very high cell mass densities in well-defined medium. Recombinant proteins in yeast can be over-expressed so the product is secreted from the cell and available for recovery in the fermentation solution. Proteins secreted by yeasts are heavily glycosylated at consensus glycosylation sites. Thus, expression of recombinant proteins in yeast systems historically has been confined to proteins where post-translations glycosylation patterns do not affect the function of proteins. Several yeast expression systems are used for recombinant protein expression, including Sacharomyces, Scizosacchromyces pombe, Pichia pastoris and Hansanuela polymorpha. 2006-02-09T05:00:00Z XML http://biopharminternational.findpharma.com/biopharm/Article/Efficient-Small-Scale-Production-of-Proteins/ArticleStandard/Article/detail/301975?contextCategoryId=41918&ref=25 Over the last three decades, numerous protein expression systems have been developed with various quality requirements on large and small scales. Huge steps have been made in large-scale protein production in mammalian systems while the small-scale mammalian systems are expensive and inflexible. Thus, small-scale production is done in simpler expression systems, sometimes sacrificing the quality of the proteins. However, relief is on the way. 2006-02-09T05:00:00Z XML http://biopharminternational.findpharma.com/biopharm/Article/Applying-Fusion-Protein-Technology-to-E-Coli/ArticleStandard/Article/detail/301977?contextCategoryId=41918&ref=25 Rapid, efficient, and cost-effective protein expression and purification strategies are required for high throughput structural genomics and the production of therapeutic proteins. Fusion protein technology represents one strategy to achieve these goals. Fusion protein technology can facilitate purification, enhance protein expression and solubility, chaperone proper folding, reduce protein degradation, and in some cases, generate protein with a native N-terminus. No technology or reagent is a panacea, however, and establishing tools and optimal conditions for each protein remains an empirical exercise. With this in mind, protein fusions are a leading option to produce difficult-to-express proteins, especially in Escherichia coli. 2006-02-09T05:00:00Z XML http://biopharminternational.findpharma.com/biopharm/Article/Flexible-Methodology-for-Developing-Mammalian-Cell/ArticleStandard/Article/detail/301978?contextCategoryId=41918&ref=25 The speed at which a recombinant protein product progresses into clinical trials is of vital importance for both small biotechnology companies as well as the biopharma groups of large pharmaceutical companies. For mammalian cell lines, two major impacts on the project timeline are the ability to quickly identify a product candidate and subsequently produce a high-expressing cell line for that product. The advent of various computer-based protein design methodologies and antibody discovery technologies for developing protein therapeutics has resulted in large numbers of protein or antibody variants that must be screened to identify the best clinical candidate. 2006-02-09T05:00:00Z XML