DOWNSTREAM PROCESSING FEATURED ARTICLES
Ablynx (EURONEXT BRUSSELS: ABLX) today announced efficacy and safety data for its anti-IL-6R Nanobody, ALX-0061, at the 24 week final analysis of the Phase II part of a combined Phase I/II study in patients with moderately to severely active rheumatoid arthritis (RA) on a stable background of methotrexate.
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![iStock-478554068]( "Update On Advanced Rapid Microbiology Methods In Biopharma")
Update On Advanced Rapid Microbiology Methods In BiopharmaA BioPhorum survey of biopharma end-users reveals the opportunity—and the challenge—involved in the adoption of advanced rapid microbiology methods. Audrey Chang, global head of development services at BioReliance Merck; Morven McAlister, senior director at Pall Biotech; and Scott Hooper, associate director at Merck & Co Inc. break down the data.
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![Capto L chromatography medium]( "GE Healthcare Life Sciences Launches Capto™ L Chromatography Medium For Capture Of Antibodies And Antibody Fragments")
GE Healthcare Life Sciences Launches Capto™ L Chromatography Medium For Capture Of Antibodies And Antibody FragmentsGE Healthcare’s Capto L affinity chromatography medium (resin) is designed for the purification of antibody fragments. It combines a rigid, high-flow agarose matrix with the immunoglobulin-binding recombinant protein L ligand, which has strong affinity for the variable region of antibody’s kappa light chain.
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Virus Engineered To Express Melanin Offers New Possibilities To Diagnose And Treat Solid Tumor Cancers
In a study released today in Proceedings of the National Academy of Sciences (PNAS), entitled "Vaccinia virus mediated melanin production allows MR and optoacoustic deep tissue imaging and laser induced thermotherapy of cancer," scientists combined the natural imaging potential of melanin with recombinant Vaccinia viruses' ability to selectively enter and replicate within tumor cells.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
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Avoiding Drug Shortages With Microbial Detection
Over the past year, critical drug shortages used to treat a host of life-threatening illnesses have been making headlines. Microbial contamination has been cited as a major contributor to the shortage, yet the prevailing practices to ensure the safety of drugs have been slow to change. In most cases, quality assurance practices safeguarding the drug making environment continue to rely on periodic air and a culturing method from a prior century. By Aric Meares, President and CEO, BioVigilant
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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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Metal Removal From Fine Chemical Products
Metal contamination in various injectable or even oral medicines is a serious concern.
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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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Chromatography Column Protection With 3M Purification LifeASSURE™ PLA Series Membrane Filters Protective, or guard, filters are often used in chromatography column purification steps to protect the column media from contaminants in the various fluids that come in contact with the column.
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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.
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.
Cytiva provides filtration solutions and support for integrated bioprocessing applications at every step and every scale of the drug development, validation and manufacturing process.
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.