DOWNSTREAM PROCESSING FEATURED ARTICLES
Pfenex Inc. Awarded Contract by the National Institute of Allergy and Infectious Diseases (NIAID) to Develop an Alternative Delivery Method for its Recombinant Protective Antigen (rPA)-based Anthrax Vaccine
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Roche Medicine Avastin Receives EU Approval For The Treatment Of Women With Recurrent, Platinum-Sensitive Ovarian Cancer
Roche announced recently that the European Commission (EC) has approved Avastin (bevacizumab) in combination with standard chemotherapy (carboplatin and gemcitabine) as a treatment for women with first recurrence of platinum-sensitive ovarian cancer.
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![73]( "BioChip May Make Diagnosis Of Leukemia And HIV Faster, Cheaper")
BioChip May Make Diagnosis Of Leukemia And HIV Faster, CheaperInexpensive, portable devices that can rapidly screen cells for leukemia or HIV may soon be possible thanks to a chip that can produce three-dimensional focusing of a stream of cells, according to researchers.
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![continuous biomanfuacturing]( "Genzyme Pioneering Continuous Manufacturing In Biotech")
Genzyme Pioneering Continuous Manufacturing In BiotechOne company that has made significant progress in the development of a continuous manufacturing platform for large molecule drugs is Genzyme. I recently spoke with Jason Walther, a staff scientist at Genzyme, about the impact of continuous manufacturing on the industry as well as its potential.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
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An Automated Profiling Application For G9a Histone Methyltransferase And Bromodomain Proteins
Due to several findings, G9a and BET bromodomain proteins have become the target for numberous drug discovery projects. In this study, we describe a novel, cell-based assay platform that uses the robust, yet simple Enzyme Fragment Complementation (EFC) Technology.
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![Bill whitford]( "Continuous Biomanufacturing: 10 Reasons Sponsors Hesitate")
Continuous Biomanufacturing: 10 Reasons Sponsors HesitateThe industry is abuzz with talk about continuous biomanufacturing (CB), and its virtues have been well described. Here we will look at some of the barriers or concerns perceived to limit its value to the industry. Justified or not, quite a few concerns have been expressed regarding the implementation of this new, rather disruptive technology.
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![Bulletin_5825Photo.jpg]( "Best Practices For Process Scale Column Packing Of CHT™ Ceramic Hydroxyapatite Media")
Best Practices For Process Scale Column Packing Of CHT™ Ceramic Hydroxyapatite MediaCHT ceramic hydroxyapatite media require specific considerations during process-scale chromatography packing due to high specific gravity, rapid settling rate, and sensitivity to mechanical shear.
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Automation Of A Homogeneous Proximity Assay For Detection Of Residual Protein A In Biological Therapeutics
Protein A is used in affinity chromatography for therapeutic antibody purification and has been shown to leach from columns during purification of antibodies resulting in contamination. Residual Protein A in therapeutic drugs could elicit mitogenic or immunological reactions in patients.
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The Challenge of Measuring Total Organic Carbon In Modern Pharmaceutical Water Systems
Total Organic Carbon (TOC) is one of the quality attributes defined in the European and USA pharmacopoeias for pharmaceutical waters. Modern water treatment systems can deliver such high purity water that TOC levels can be consistently close to zero and very difficult to measure with any accuracy. This paper discusses some of the challenges when using TOC analysers to demonstrate pharmacopoeial TOC level compliance for modern water systems in the light of the ICH Q2 document from the International Conference on Harmonisation.
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Biomanufacturing Supply Chains
This white paper examines the major issues with biopharmaceutical supply chains and how to balance inventory and risk optimally in the network.
DOWNSTREAM PROCESSING PRODUCTS
ÄKTA™ chromatography systems can handle both simple and complex purification tasks and accelerate daily routines. All systems are controlled by UNICORN™ software, a common control platform and user interface for all scales of operation.
CHT is a leading purification medium of biomolecules in today’s demanding downstream process industry. Its mixed-mode support offers unique selectivities and often separates biomolecules that appear homogeneous with other chromatographic methods. The diverse binding capabilities of CHT for host cell proteins, leached protein A, antibody dimers and aggregates, nucleic acids, and viruses allow its use at any stage from initial capture to final polishing.
DOWNSTREAM PROCESSING MULTIMEDIA
Bioprocess With The Bozenhardts is back, with a fresh episode packed with advice from Herman and Erich on the selection of filling systems for biopharmas. Listen in as the Bozenhardts give us an update on the process, logistics, and administration trends that are informing filling system decisions today, and offer direction on making choices that will prepare you for the fast-advancing therapies of tomorrow.
Bio-Rad now offers two very high capacity ion exchangers: Nuvia S, which can be used for capture and/or intermediate polishing; and Nuvia Q, which can be used for intermediate and/or final polishing.