DOWNSTREAM PROCESSING FEATURED ARTICLES
FlexFill Single-Use Transfer Assembly
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Sanofi And PATH Announce The Launch Of Large-Scale Production Of Semisynthetic Artemisinin Against Malaria
Sanofi (Euronext: SAN and NYSE: SNY) and PATH’s Drug Development program, established through an affiliation with OneWorld Health, today announced the launch of the large-scale production line of semisynthetic artemisinin at Sanofi’s Garessio site in Italy.
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FDA Approves First Drug-Eluting Stent To Treat Peripheral Arterial Disease
The U.S. Food and Drug Administration approved the Zilver PTX Drug-Eluting Peripheral Stent (Zilver PTX Stent), the first drug-eluting stent indicated to re-open a particular artery in the thigh (femoropopliteal artery) when narrowed or blocked as a result of peripheral artery disease (PAD).
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![Kubio biopharm model]( "GE Healthcare launches modular biopharmaceutical factory, KUBio")
GE Healthcare launches modular biopharmaceutical factory, KUBioGE Healthcare, the healthcare business of GE, today introduced KUBio™, an innovative off-the-shelf, modular factory designed to save manufacturers of biopharmaceuticals both time and money. KUBio’s pre-made modules, which are assembled at a customer’s chosen site to make a fully functional ready-to-run bioprocessing facility, are significantly faster to install than constructing a traditional factory.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
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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.
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![Monoclonal Antibody Purification Platform Using High-Capacity Protein A And Mixed-Mode Chromatography]( "Monoclonal Antibody Purification Platform Using High-Capacity Protein A And Mixed-Mode Chromatography")
Monoclonal Antibody Purification Platform Using High-Capacity Protein A And Mixed-Mode ChromatographyThe first step in purification of an important class of therapeutic proteins, the polyclonal or monoclonal antibodies (mAbs), is their capture from plasma or tissue culture supernatants. Protein A–based media are by far the most common class of affinity products used for this purpose.
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Efficiency Test Of ReadyToProcess™ Columns
ReadyToProcess™ columns are prepacked, prequalified, and presanitized process chromatography columns suited for purification of biopharmaceuticals (e.g., proteins, vaccines, plasmids, and viruses) for clinical phase I and II studies. ReadyToProcess columns are available with several media at different volumes (1, 2.5, 10, and 20 L).
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Proven Long Life Lasers™ In Optical Particle Counters Optical particle counters (OPC) utilize light illumination and extinction to determine the presence, size, number and/or concentration of particles. Particles are typically suspended in a fluid or air, which flow through the volume that is illuminated and viewed by the detection system.
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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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Sani-Tech® Ultra White Paper
For several years, pharmaceutical manufacturing professionals have increasingly stated concerns about material leachables and extractables and their impact on the products they produce. Fluid transfer systems that include flexible tubing have been at the forefront of this discussion.
DOWNSTREAM PROCESSING PRODUCTS
Capto Core 700 is a multimodal chromatography medium designed for purification of large proteins or viruses in vaccine processes.
Resin are designed specifically for intermediate purification steps that remove host-cell contaminants from partially purified targets using strong or weak hydrophobic interactions. Methacrylate-based beads for protein and nucleic acid purification using hydrophobic interactions are available for purifying compounds that have weak or strong hydrophobic regions.
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.