Downloads http://www.bioresearchonline.com/ 12/3/2008 12:36:00 AM As biopharmaceutical manufacturers experience the benefits of single-use systems, many want to expand their use in both upstream and downstream applications. This isn't surprising, considering that the increased volume and diversity of biopharmaceutical products are causing manufacturers to design their facilities based on shorter production runs with multiple changeovers. Meeting such demands requires operational flexibility. <i>By John Boehm and Brent Bushnell</i> http://www.bioresearchonline.com/download.mvc/Providing-Sterility-Assurance-0001?atc~c=771+s=774+r=001+l=a 12/3/2008 12:36:00 AM As the biopharmaceutical industry continues to evolve and mature, the challenges facing it change as well. Among many other pressures, bioprocessors are increasingly pressured to shorten drug development timelines, reduce costs, diversify product pipelines, and implement riskbased strategies, not to mention maintaining continued focus on patient safety and regulatory compliance. <i>By BioProcess International</i> http://www.bioresearchonline.com/download.mvc/Evolving-Toward-Single-Use-Bioprocessing-0001?atc~c=771+s=774+r=001+l=a 12/3/2008 12:02:00 AM A research process developed in shake flasks and 0.6L bioreactors was transferred from an independent development laboratory and rapidly scaled up to a 100L production bioreactor. A newly developed, commercially available, chemically defined basal and feed medium combination designed specifically for cGMP fed-batch production was a key element in this success. http://www.bioresearchonline.com/download.mvc/r-CHO-Cell-Fed-Batch-Process-0001?atc~c=771+s=774+r=001+l=a 12/2/2008 10:48:00 AM A fed-batch bioreactor process for a CHO cell line was transferred from a client and scaled 200 fold with minimal process development evaluation and testing. http://www.bioresearchonline.com/download.mvc/Scale-Up-Of-A-Fed-Batch-Bioreactor-Process-0001?atc~c=771+s=774+r=001+l=a 12/2/2008 10:41:00 AM Reduced aggregate level in large scale manufacturing downstream process from very high to undetectable levels. http://www.bioresearchonline.com/download.mvc/Development-Of-A-Drop-In-Purification-Step-0001?atc~c=771+s=774+r=001+l=a 12/2/2008 10:32:00 AM The versatile Bio-Rad process chromatography skid can be customized for different applications using a core platform and integrating optional hardware. http://www.bioresearchonline.com/download.mvc/Bio-Rad-Process-Chromatography-Skid-0002?atc~c=771+s=774+r=001+l=a 12/2/2008 7:41:00 AM The Bio-Rad media transfer device is a self-contained movable unit designed to transfer chromatography media between a tank and the column and to deliver cleaning solutions to Bio-Rad InPlace columns for sanitization. http://www.bioresearchonline.com/download.mvc/Bio-Rad-Media-Transfer-Device-0002?atc~c=771+s=774+r=001+l=a 12/2/2008 7:38:24 AM The Bio-Rad MainFrame lifting accessory enables hoist-free operation of chromatography columns. http://www.bioresearchonline.com/download.mvc/Bio-Rad-MainFrame-Lifting-Accessory-0002?atc~c=771+s=774+r=001+l=a 12/2/2008 7:31:00 AM Bio-Rad EasyPack columns offer a traditional approach to process columns for biopharmaceutical applications. http://www.bioresearchonline.com/download.mvc/Bio-Rad-Easypack-Column-0001?atc~c=771+s=774+r=001+l=a 12/2/2008 7:27:00 AM Catalent's regulatory and clinical experts have a wide range of in-depth experience with both established and novel pharmaceutical dosage forms across a wide range of therapeutic areas. The global regulatory services group has an extensive consulting portfolio. http://www.bioresearchonline.com/download.mvc/Global-Regulatory-Services-0001?atc~c=771+s=774+r=001+l=a 11/26/2008 11:48:00 PM Biotechnology promises treatments and even cures for many diseases previously considered intractable. Although the biotech industry began just about a quarter-century ago, since the late 1990s the number of new biopharmaceutical approvals has nearly equaled those for new small-molecule drugs. <i> By Frances L. DeGrazio </i> http://www.bioresearchonline.com/download.mvc/Parenteral-Concerns-For-Biotech-Drugs-0001?atc~c=771+s=774+r=001+l=a 11/25/2008 11:53:00 PM We all want to make sure that the drugs that we buy and use to treat and cure illness are safe. Because of the complexity of human biology, there can be no 100% guaranty that a drug will work without causing some other problem (e.g., dizziness, nausea, or sleeplessness). To ensure that the public and patients' interests are considered to the highest degree, we rely on regulatory agencies to enforce rules governning everything going into the development and manufacture of a drug. <i>By Leah J. Rosin </i> http://www.bioresearchonline.com/download.mvc/If-You-Didnt-Write-It-Down-It-Didnt-Happen-0001?atc~c=771+s=774+r=001+l=a 11/25/2008 11:33:00 PM CD has been demonstrated effective in both the aqueous and gas phases, which is highly advantageous for biopharmaceutical applications. It is easy to change CD from one state to the other. One benefit of the membrane sachet technology (see below) is that it can be used to generate an aqueous solution that can be stored until needed. <i>By Barry Wintner, Anthony Contino, and Gary O'Neill, BioProcess International</i> http://www.bioresearchonline.com/download.mvc/Feature-Article-Chlorine-Dioxide-Part-2-0001?atc~c=771+s=774+r=001+l=a 11/21/2008 9:28:00 AM Any modification of a natural protein (by either chemical means or site-directed mutagenesis) for use as a biotherapeutic immediately raises the issue of immunogenicity and, to a lesser extent, stability. Indeed, development of antibodies against therapeutics is receiving increased study. Immune reactions secondary to administration of protein therapeutics is not a new problem and was a major issue with animal-derived insulin products. <i>By Roger L. Lundblad and Ralph A. Bradshaw, BioProcess International</i> http://www.bioresearchonline.com/download.mvc/Feature-Article-Addressing-Product-Improvemen-0001?atc~c=771+s=774+r=001+l=a 11/21/2008 9:18:00 AM LONG&reg;R<Sup>3</sup>IGF-I is available as a lyophilized powder, Catalog No. 85580C, or a 1 mg/mL liquid formulation in 100 mM acetic acid, Catalog No. 91590C. Both formats are shipped at ambient temperature and stored at 2 to 8 C. http://www.bioresearchonline.com/download.mvc/LONGR3IGF-I-Storage-Stability-Specifications-0001?atc~c=771+s=774+r=001+l=a 11/20/2008 11:47:00 AM LONG&reg;R³IGF-I is a dedicated raw material manufactured exclusively for cell culture applications providing a consistent, compliant and reliable alternative to recombinant insulin. It is not subject to market fluctuations and shortages as is recombinant insulin. http://www.bioresearchonline.com/download.mvc/LONG-R3IGF-I-FAQ-Strategic-Sourcing-0001?atc~c=771+s=774+r=001+l=a 11/20/2008 11:43:00 AM LONG&reg;R³IGF-I is a dedicated raw material manufactured exclusively for cell culture applications providing a consistent, compliant and reliable alternative to recombinant insulin. It is not subject to market fluctuations and shortages as is recombinant insulin. http://www.bioresearchonline.com/download.mvc/LONGR3IGF-I-Frequently-Asked-Questions-0001?atc~c=771+s=774+r=001+l=a 11/20/2008 11:40:00 AM LONG&reg;R<Sup>3</sup>IGF-I is a recombinant analog of human insulin-like growth factor-I (IGF-I) that has been specifically engineered for the enhancement of cell culture performance. http://www.bioresearchonline.com/download.mvc/LONGR3IGF-I-Liquid-0001?atc~c=771+s=774+r=001+l=a 11/20/2008 11:16:00 AM LONG&reg;R³IGF-I is a dedicated raw material manufactured exclusively for cell culture applications providing a consistent, compliant and reliable alternative to recombinant insulin. It is not subject to market fluctuations and shortages as is recombinant insulin. http://www.bioresearchonline.com/download.mvc/LONGR3IGF-I-Your-Insulin-Alternative-0001?atc~c=771+s=774+r=001+l=a 11/20/2008 11:16:00 AM LONG&reg;R<Sup>3</sup>IGF-I is a recombinant growth factor analog of human insulin-like growth factor I (IGF-I). It is specifically designed and manufactured for mammalian cell culture and is intended to support large-scale manufacturing of biopharmaceuticals. http://www.bioresearchonline.com/download.mvc/The-Science-of-LONGR3IGF-ISAFC-0001?atc~c=771+s=774+r=001+l=a 11/20/2008 11:16:00 AM