DOWNSTREAM PROCESSING FEATURED ARTICLES
Researchers have discovered a unique monoclonal antibody that can effectively reach inside a cancer cell, a key goal for these important anticancer agents, since most proteins that cause cancer or are associated with cancer are buried inside cancer cells.
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![Service Package Options]( "Making The Switch To Single-Use: Have You Thought Of Everything?")
Making The Switch To Single-Use: Have You Thought Of Everything?In 2014, Prolong Pharmaceuticals followed through with a decision to build a facility for the scale-up of their lead product, SANGUINATE. As part of this decision, the new facility would not utilize Prolong’s traditional manufacturing process and would instead switch to one that uses single-use technology (SUT) almost exclusively. Chuck Hart, Prolong’s director of manufacturing, recently sat down with me to discuss some areas he feels are sometimes overlooked when switching from traditional stainless steel to SUT.
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![nalgeneNunc]( "Synergies For Equipping The Single-Use Bioproduction Suite")
Synergies For Equipping The Single-Use Bioproduction Suite The growth of biopharmaceuticals entering the market has served to change the appearance of the bioproduction suite -
Aseptika Ltd Launches Time Saving Single-Use Bioreactor Sampler Aseptika Ltd launches Time Saving Single-use Bioreactor Sampler Aseptika Ltd, an innovator in the development of clean technologies for the Biopharmaceutical industry, has launched their Bioreactor Sampler
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
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Managing Cell-Based Potency Assays: From Development To Lifecycle Maintenance
Characterization of a biological product — which includes the determination of physicochemical properties, biological activity, immunochemical properties, purity and impurities — is necessary to establish the safety and efficacy profile of a given product (ICH Q6B). By Dr. Weihong Wang, manager, Molecular and Cell Biology, Eurofins Lancaster Laboratories
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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.
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Materials Of Construction For Biopharmaceutical Water Systems
Stainless steels are uniquely qualified for bioprocessing applications not only because of their long service life, availability, and fabricability, but also because they are non-corroding, non-contaminant, can be polished to very smooth finishes, are strong and rigid, can withstand heat and chemical sterilization treatments, and are easily welded. By Michelle M. Gonzalez
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![Bio-rad]( "Selecting The Optimal Resins For The Process Purification Of Native And Recombinant Proteins")
Selecting The Optimal Resins For The Process Purification Of Native And Recombinant ProteinsNative and recombinant proteins are used in a variety of applications ranging from drug discovery to target validation to high-throughput screening. Due to this, large-scale protein production and purification have become major necessities in industrial settings.
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![A Purification Strategy For Clinical-Grade Monoclonal Antibody]( "A Purification Strategy For Clinical-Grade Monoclonal Antibody")
A Purification Strategy For Clinical-Grade Monoclonal AntibodymAbs are currently the most important class of therapeutic proteins. Advances in upstream process technologies have led to tremendous improvement of mAb titers in mammalian cell culture.
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Removal Of Host Cell Proteins During Monoclonal Antibody Purification
Protein A chromatography is a widely used and highly successful method of purifying recombinant monoclonal antibodies. However, since Protein A has high affinity for antibodies, harsh conditions such as low pH are often required to elute monoclonal antibodies from Protein A affinity columns. By 3M Purification Inc
DOWNSTREAM PROCESSING PRODUCTS
Magnosphere™ is a superparamagnetic particle for in vitro diagnostics and bio research applications.
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.
AseptiQuik® STC Connectors integrate the AseptiQuik® sterile connector and the Steam-Thru® II SIP connector, giving manufacturers even greater flexibility for hybrid stainless steel and single-use processing.
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.