DOWNSTREAM PROCESSING FEATURED ARTICLES
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) for its IgG Antibody to herpes simplex virus (HSV) types 1 and 2 assays for use on cobas® modular platforms. The tests are intended for use with sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-1 and HSV-2 infection.
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3M Purification Inc. Introduces New Zeta Plus Encapsulated, Single-Use Depth Filtration Products
3M Purification Inc. has expanded its portfolio of Encapsulated Zeta Plus single-use depth filtration capsules. The two new product lines – Zeta Plus Scale-up Capsule Filters and new single-layer media grades for Zeta Plus Encapsulated capsules – are designed with our industry leading Zeta Plus depth filter media, designed for applications in the bio-pharmaceutical industry including cell culture clarification, downstream process protection, virus, DNA and lipid reduction, and host cell protein (HCP), protein aggregate, endotoxin and anti-foaming agent removal.
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![Klyachkoneuron]( "Fragile X Makes Brain Cells Talk Too Much")
Fragile X Makes Brain Cells Talk Too MuchThe most common inherited form of mental retardation and autism, fragile X syndrome, turns some brain cells into chatterboxes, scientists at Washington University School of Medicine in St. Louis report. By Michael C. Purdy
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FDA Approves New Seasonal Influenza Vaccine Made Using Novel Technology
The U.S. Food and Drug Administration recently announced that it has approved Flublok, the first trivalent influenza vaccine made using an insect virus (baculovirus) expression system and recombinant DNA technology. Flublok is approved for the prevention of seasonal influenza in people 18 through 49 years of age.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
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![Bacteria 450x300]( "Selecting The Optimal Resins For Endotoxin Depletion In Process Purification")
Selecting The Optimal Resins For Endotoxin Depletion In Process PurificationA guide to effectively remove endotoxins with versatile process resins.
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Biological Contamination Events In Isolators: What Lessons Can Be Learned?
Microbiological deviation and biological contamination events have been observed in pharmaceutical isolators including those used in production, sterility test and pharmacy aseptic services. By James Drinkwater, Bioquell UK Process & Compliance Director
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![Bio-rad]( "Improving Aggregate Removal From mAb Feed Using Cation Exchange Chromatography")
Improving Aggregate Removal From mAb Feed Using Cation Exchange ChromatographyResearchers in the field of chromatography have required ever more sophisticated and selective methods for removing aggregates from the monomer.
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A Disposable Valve For Process Chromatography
This case study discusses the need for a fully automated, disposable chromatography system which was PLC controlled and designed for use in a cGMP environment. The required applications for the chromatography system included contamination removal, and concentration and purification of biologically derived proteins used in the production of research and clinical materials.
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Turning Data Into Information
As biopharmaceutical manufacturing has evolved from small-scale lab production in small flasks to massive commercial production in deep-tank bioreactors, an avalanche of production data has evolved to support it. From individual unit operation skids to distributed control systems and enterprise resource planning tools, biomanufacturing today is buried by the sheer quantity of data coming in from the manufacturing floor.
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![CPC AQ variety (feature)]( "Single-Use Connections Advance Aseptic Processing")
Single-Use Connections Advance Aseptic ProcessingJohn Boehm discusses how single-use connections advance aseptic processing and create increased process flexibility and reliability while reducing costs.
DOWNSTREAM PROCESSING PRODUCTS
Amsphere™ A3 is a next generation Protein A chromatography resin for advanced protein separation in downstream processing of therapeutic antibodies manufacturing. With high capacity resin, Amsphere™ A3 has an overall improved process robustness, flow characteristics, optimized impurity removal, productivity and resin lifetime.
Sartopure PP2 Cartridges were optimized for the wide range of prefiltration.
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.