http://biopharminternational.findpharma.com/biopharm/Disposables/Article/list/35801 The advantages and disadvantages of disposables, along with cost-benefit analyses, validation strategies, and implementation approaches. 2009-11-21T14:44:19Z http://biopharminternational.findpharma.com/biopharm/Disposables+Articles/Integrating-Single-Use-Connection-Components-into-/ArticleStandard/Article/detail/637585?contextCategoryId=35801&ref=25 Single-use connections can help drug manufacturers maximize efficiency in every step of the manufacturing process. 2009-11-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/442009/637585null XML http://biopharminternational.findpharma.com/biopharm/Disposables+Articles/A-Review-of-Sterile-Connectors/ArticleStandard/Article/detail/637917?contextCategoryId=35801&ref=25 Many factors must be considered when choosing a sterile connector for a given process. 2009-11-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/442009/637917null XML http://biopharminternational.findpharma.com/biopharm/Disposables+Articles/Scale-Up-and-Comparison-Studies-Evaluating-Disposa/ArticleStandard/Article/detail/637918?contextCategoryId=35801&ref=25 Process performance was comparable across all scales, and fiber optic sensors appeared interchangeable with conventional probes. 2009-11-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/442009/637918null XML http://biopharminternational.findpharma.com/biopharm/Disposables+Articles/Freeze-Bulk-Bags-A-Case-Study-in-Disposables-Imple/ArticleStandard/Article/detail/637583?contextCategoryId=35801&ref=25 Genentech's evaluation of single-use technologies for bulk freeze-thaw, storage, and transportation. 2009-11-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/442009/637583null XML http://biopharminternational.findpharma.com/biopharm/Trends/Laboratory-Equipment/ArticleStandard/Article/detail/627754?contextCategoryId=35801&ref=25 To assess current trends in laboratory equipment, BioPharm International turned to Francis Bach, North American sales director, Asahi Kasei TechniKrom, Inc.; Erika Lapinskas, PhD, product manager, Sartorius Stedim Biotech; Jeffrey R. Mazzeo, PhD, biopharmaceutical business director, Waters Corporation; Amber Ratcliff, product manager, analytical sensors, Hamilton Company; and Josh Silverstone, marketing director, Millipore Corp. 2009-09-18T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/382009/627754null HTML http://biopharminternational.findpharma.com/biopharm/Trends/Single-Use-Bioprocessing-Equipment/ArticleStandard/Article/detail/627768?contextCategoryId=35801&ref=25 To assess current trends in single-use bioprocessing equipment, BioPharm International turned to John Boehm, bioprocessing business unit manager, Colder Products Company; Mandar Dixit, head of product management?filtration technologies, Sartorius Stedim Biotech; Geoff Hodge, managing director of process technology Xcellerex, Inc.; Günter Jagschies, senior director of strategic customer relations, life sciences, biotechnologies, GE Healthcare; Mani Krishnan, director of product management, Mobius single-use technologies, Millipore Corporation; and Jerry Martin, senior vice president of scientific affairs, Pall Life Sciences, and board chairman and technology chair at BPSA. 2009-09-18T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/382009/627768null HTML http://biopharminternational.findpharma.com/biopharm/Disposables+Advisor/The-Role-of-Disposables-in-Rapid-Response-Manufact/ArticleStandard/Article/detail/615154?contextCategoryId=35801&ref=25 Single-use technologies can be configured and installed fairly quickly, but are they ready to handle the urgency and scale of a pandemic? 2009-08-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/312009/615154null XML http://biopharminternational.findpharma.com/biopharm/Disposables+Advisor/User-Viewpoints-on-Disposables-Implementation/ArticleStandard/Article/detail/601411?contextCategoryId=35801&ref=25 What end users think about single-use systems. 2009-06-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232009/601411null XML http://biopharminternational.findpharma.com/biopharm/Disposables+Advisor/Disposables-Cost-Contributions-A-Sensitivity-Analy/ArticleStandard/Article/detail/590348?contextCategoryId=35801&ref=25 Cost modeling provides valuable insights to support strategic decision-making when implementing disposable technologies. 2009-04-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/142009/590348null XML http://biopharminternational.findpharma.com/biopharm/Disposables+Advisor/Evaluating-Disposable-Mixing-Systems/ArticleStandard/Article/detail/580775?contextCategoryId=35801&ref=25 How to choose a disposable mixing system that fits your particular needs. 2009-02-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/072009/580775null XML http://biopharminternational.findpharma.com/biopharm/Fermentation+%26+Cell+Culture+Articles/Versatility-of-a-Single-Use-Bioreactor-Platform-fo/ArticleStandard/Article/detail/580776?contextCategoryId=35801&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/Disposables+Articles/An-Alternative-to-the-Scale-up-and-Distribution-of/ArticleStandard/Article/detail/575563?contextCategoryId=35801&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/Disposables+Advisor/Disposable-Technologies-Implementation-Understandi/ArticleStandard/Article/detail/568931?contextCategoryId=35801&ref=25 In new disposables projects, it is critical that engineering, procurement, and operations groups work together early on to manage supply chain risk. 2008-12-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/492008/568931null XML http://biopharminternational.findpharma.com/biopharm/Disposables+Articles/Disposables-for-Bioprocessing-Making-the-Transitio/ArticleStandard/Article/detail/566013?contextCategoryId=35801&ref=25 Transitioning from stainless steel technology to disposable technology in bioprocessing. 2008-11-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566013null XML http://biopharminternational.findpharma.com/biopharm/Disposables+Articles/Lifecycle-Cost-Analysis-for-Single-Use-Systems/ArticleStandard/Article/detail/566011?contextCategoryId=35801&ref=25 This article describes a quick method for evaluating lifecycle costs for single-use systems against their more conventional stainless-steel counterparts. 2008-11-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566011null XML http://biopharminternational.findpharma.com/biopharm/Disposables+Articles/The-Environmental-Impact-of-Disposable-Technologie/ArticleStandard/Article/detail/566014?contextCategoryId=35801&ref=25 Can disposables reduce your facility's environmental footprint? We have compared the environmental footprint of a traditional biopharmaceutical manufacturing facility using fixed-in-place stainless steel equipment, and a facility implementing disposable technologies for cell culture, solution mixing and hold, product hold, and liquid transfer. 2008-11-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566014null XML http://biopharminternational.findpharma.com/biopharm/Disposables+Articles/Systematic-Evaluation-of-Single-Use-Systems-Using-/ArticleStandard/Article/detail/566015?contextCategoryId=35801&ref=25 This article describes the steps required to build a comprehensive model in a batch process simulator for a process that uses single-use systems for buffer preparation and storage. 2008-11-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566015null XML http://biopharminternational.findpharma.com/biopharm/Disposables+Articles/Disposable-Bioreactors-for-Cells-and-Microbes/ArticleStandard/Article/detail/566012?contextCategoryId=35801&ref=25 Productivities similar to those achieved with stirred tanks can be achieved with disposable bioreactors. 2008-11-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566012null XML http://biopharminternational.findpharma.com/biopharm/From+the+Editor/The-Environmental-Impact-of-Disposables/ArticleStandard/Article/detail/566016?contextCategoryId=35801&ref=25 Despite creating plastic waste, the disposables option is better for the environment. 2008-11-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566016null XML http://biopharminternational.findpharma.com/biopharm/Disposables+Articles/The-Challenges-and-Benefits-of-Disposable-Technolo/ArticleStandard/Article/detail/566026?contextCategoryId=35801&ref=25 Interview with David Radspinner, director of global marketing & customer applications, bioprocess production at Thermo Fisher Scientific. 2008-11-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566026null XML http://biopharminternational.findpharma.com/biopharm/Manufacturing+Economics+Articles/Disposable-Decisions/ArticleStandard/Article/detail/557242?contextCategoryId=35801&ref=25 To achieve the right balance between disposable and reuseable options, companies must consider important technical and economic factors. 2008-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412008/557242null XML http://biopharminternational.findpharma.com/biopharm/Disposables+Advisor/Disposables-Open-Up-Possibilities-in-Facility-Desi/ArticleStandard/Article/detail/532051?contextCategoryId=35801&ref=25 In addition to making technical developments, vendors are also looking at ways to improve supply-chain security. By offering standard, off-the-shelf products, vendors are able to shorten lead times and improve the security of supply. 2008-08-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/312008/532051null XML http://biopharminternational.findpharma.com/biopharm/Disposables+Advisor/How-to-Evaluate-the-Cost-Impact-of-Using-Disposabl/ArticleStandard/Article/detail/522179?contextCategoryId=35801&ref=25 The current focus on cost-of-goods (COGS) models is underplaying the benefits of disposables technology in biopharmaceutical manufacturing. The best method for accounting for the benefits of reduced and delayed capital expenditures is through the use of NPV analysis. 2008-06-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232008/522179null XML http://biopharminternational.findpharma.com/biopharm/Disposables+Advisor/Disposable-Bioreactors-The-Next-Generation/ArticleStandard/Article/detail/507470?contextCategoryId=35801&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/Disposables/Extractables-and-Leachables-Study-Approach-for-Dis/ArticleStandard/Article/detail/490803?contextCategoryId=35801&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/Antibody-Purification-with-an-Integrated-Disposabl/ArticleStandard/Article/detail/473324?contextCategoryId=35801&ref=25 Comparison of the integrated assembly purified MGG to the control revealed that the purity if the MGG was very high. 2007-11-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462007/473324null XML http://biopharminternational.findpharma.com/biopharm/Disposables/Single-Use-TechnologiesmdashA-Contract-Biomanufact/ArticleStandard/Article/detail/473325?contextCategoryId=35801&ref=25 One of the challenges of adopting single-use technology is that not all cell lines are compatible with disposable bioreactors. 2007-11-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462007/473325null XML http://biopharminternational.findpharma.com/biopharm/Disposables/A-Next-Step-in-Implementing-Disposables-Transfer-L/ArticleStandard/Article/detail/473326?contextCategoryId=35801&ref=25 Single-use systems reduce maintenance and capital expense by eliminating expensive vessels, valves, and sanitary piping assemblies. 2007-11-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462007/473326null XML http://biopharminternational.findpharma.com/biopharm/Disposables/Disposable-Process-for-cGMP-Manufacture-of-Plasmid/ArticleStandard/Article/detail/473323?contextCategoryId=35801&ref=25 Disposables are increasingly being used in the manufacture of biopharmaceuticals. This article describes the design of a fully disposable process for the cGMP manufacture of clinical trial grade plasmid DNA. It addresses the rationale for implementing such a process with respect to the manufacture of patient-specific plasmid DNA vaccines for the treatment of leukemia. The process incorporates a number of disposable technologies, which are simple to use and thus reduce the need for investment in expensive equipment and cleaning validation. 2007-11-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462007/473323null XML http://biopharminternational.findpharma.com/biopharm/Disposables/Design-and-Testing-of-a-Prototype-Large-Scale-Bag-/ArticleStandard/Article/detail/473322?contextCategoryId=35801&ref=25 A solution for the problems of a "bag in a can" system would be a fully jacketed and insulated container, similar to a traditional freeze tank. 2007-11-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462007/473322null XML http://biopharminternational.findpharma.com/biopharm/Article/Manufacturing-Vaccines-in-Adherent-Cell-Lines-Usin/ArticleStandard/Article/detail/444994?contextCategoryId=35801&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/Article/Disposables-Biopharmaceutical-Disposables-as-a-Dis/ArticleStandard/Article/detail/432391?contextCategoryId=35801&ref=25 Today, most disposables are used for process development and clinical-scale manufacturing. Substantial growth in disposables usage may not occur until disposables are incorporated into the production of licensed products at commercial scale. 2007-06-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232007/432391/disposables_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232007/432391null XML http://biopharminternational.findpharma.com/biopharm/Article/Disposable-Bioreactors-Based-on-Wave-Agitation-Tec/ArticleStandard/Article/detail/423196?contextCategoryId=35801&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/Separation-amp-Purification-Endotoxin-Reduction-Us/ArticleStandard/Article/detail/423190?contextCategoryId=35801&ref=25 Membrane-based chromatography technologies sometimes offer advantages over resin-based technologies. 2007-05-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182007/423190/chromatography_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182007/423190null XML http://biopharminternational.findpharma.com/biopharm/Article/From-the-Editor-The-Industrys-Disposition-Toward-D/ArticleStandard/Article/detail/407869?contextCategoryId=35801&ref=25 Disposables are no longer a mistrusted new technology; they're seen as a potential solution to everyday problems. 2007-03-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/092007/407869null XML http://biopharminternational.findpharma.com/biopharm/Article/Scaling-Up-Disposable-Membrane-Chromatography/ArticleStandard/Article/detail/384808?contextCategoryId=35801&ref=25 In recent years, disposable membrane chromatography has gained acceptance as a robust device for large-scale processing. 2006-11-09T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/452006/384808null HTML http://biopharminternational.findpharma.com/biopharm/Article/Properties-of-Materials-Used-in-Single-Use-Flexibl/ArticleStandard/Article/detail/423541?contextCategoryId=35801&ref=25 The adoption of single-use containers in the biopharmaceutical industry is becoming more frequent as the popularity and availability of the technologies increase. The choice of a solution for storage in single-use containers clearly depends on the application and the inherent risks associated with the application. A "one fits all" single-use system cannot respond to all the requirements of a particular step in a biopharmaceutical process, much less to all the steps of a process. The needs of an application will lead to very specific single-use solutions. 2006-11-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182007/423541null XML http://biopharminternational.findpharma.com/biopharm/Article/Simplifying-Validation-of-Disposable-Technologies-/ArticleStandard/Article/detail/423542?contextCategoryId=35801&ref=25 Filtration systems exemplify disposable technologies that can be presterilized. 2006-11-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182007/423542null XML http://biopharminternational.findpharma.com/biopharm/Quality/Disposables-in-the-Quality-Control-Laboratory/ArticleStandard/Article/detail/423543?contextCategoryId=35801&ref=25 The deliberate reuse of disposables has caused many clinically significant problems. 2006-11-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182007/423543null XML http://biopharminternational.findpharma.com/biopharm/Article/Successful-Project-Management-for-Implementing-Sin/ArticleStandard/Article/detail/423544?contextCategoryId=35801&ref=25 In its early days, the biotech industry was almost entirely science driven, but it has since expanded from a laboratory environment to a sophisticated and dynamic manufacturing environment. As technological discoveries are increasingly translated into commercial products, biotech companies are realizing that they must generate a stronger return on assets. 2006-11-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182007/423544null XML http://biopharminternational.findpharma.com/biopharm/Article/Disposable-Biopharmaceutical-ProcessesndashMyth-or/ArticleStandard/Article/detail/423540?contextCategoryId=35801&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/Production-Cost-Analysis-Economic-Analysis-as-a-to/ArticleStandard/Article/detail/391532?contextCategoryId=35801&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/Disposables-A-Solution-for-Efficient-Biopharmaceut/ArticleStandard/Article/detail/353133?contextCategoryId=35801&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/The-Case-for-Disposable-Manufacturing-Equipment-to/ArticleStandard/Article/detail/329361?contextCategoryId=35801&ref=25 Disposables can be used for media preparation, clarification, filling in downstream processes . . . 2006-06-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/212006/329361/TN_thumbnail.jpg XML http://biopharminternational.findpharma.com/biopharm/Disposables/Disposables-Solve-Tomorrows-Manufacturing-Problems/ArticleStandard/Article/detail/170621?contextCategoryId=35801&ref=25 Disposable technology has been used effectively as a process solution for over 25 years and new uses and applications are constantly being developed. The key to all applications is the ability to pre-sterilize components and systems with gamma radiation and package them against contamination. 2005-07-01T04:00:00Z XML http://biopharminternational.findpharma.com/biopharm/Feature+Rotating+Article/Boosting-Mammalian-Cell-line-Manufacturing-Pilot-P/ArticleStandard/Article/detail/170702?contextCategoryId=35801&ref=25 Cell-line and process development expertise, along with disposable systems, assist in implementing strategies for fast expression enhancements. 2005-07-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/292005/170702/TN_thumbnail.jpg XML http://biopharminternational.findpharma.com/biopharm/Disposables/Final-Word-Disposable-Systems-Meet-Todays-Manufact/ArticleStandard/Article/detail/146352?contextCategoryId=35801&ref=25 Disposable products and systems have come a long way since they first entered the small-lab market in the 1970s. Today they are available for practically every aspect of biopharmaceutical manufacturing. Disposable systems are used for filtration, clarification, purification, and separation applications used in the production of vaccines, monoclonal antibodies, and other therapies. As the use of disposable systems grows, the concept of a completely disposable manufacturing process is becoming a reality. 2005-02-01T05:00:00Z XML