DOWNSTREAM PROCESSING FEATURED ARTICLES
How Can You Mitigate The Risks Of Single-Use Bags?
The loss of product as a result of bag failure isn’t just an annoyance; it’s an expense, and a costly one at that. However, Chuck Hart, director of manufacturing at Prolong Pharmaceuticals, says with proper fitting and handling, these concerns can be mitigated.
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FDA Approves New Combination Vaccine That Protects Children Against Two Bacterial Diseases
The U.S. Food and Drug Administration recently approved Menhibrix, a combination vaccine for infants and children ages 6 weeks through 18 months, for prevention of invasive disease caused by Neisseria meningitidis serogroups C and Yand Haemophilus influenzae type b.
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New Protein A Media Boosts Productivity In Monoclonal And Polyclonal Antibody Capture, Lowers Costs Novasep, a leading supplier of manufacturing solutions to the life sciences industries, announces recently the launch of AbSolute High Cap, a new generation protein A media, based on modified silica.
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![hplc]( "LEWA Uses A Globally Exclusive License To HPLC Technology From Bayer Technology Services")
LEWA Uses A Globally Exclusive License To HPLC Technology From Bayer Technology ServicesBayer Technology Services (BTS) is a well-known supplier of industrial chromatography products and services in the area of process technologies for the Bayer Group and for external customers.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
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Biomanufacturing Complexity
This white paper addresses one of the most serious challenges facing biomanufacturing professionals today - how to understand and then deal with the extreme complexity associated with biotechnology manufacturing.
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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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![Bio-rad]( "Mammalian Virus Purification Using Ceramic Hydroxyapatite")
Mammalian Virus Purification Using Ceramic HydroxyapatiteConventional techniques for mammalian virus purification produce variable quality, quantity, and significant loss of particle infectivity. We propose the chromatographic separation of viral particles of diverse sizes and from different families such as dengue, influenza, mouse hepatitis, adenovirus, poliovirus using CHT Ceramic Hydroxyapatite resin.
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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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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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![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.
DOWNSTREAM PROCESSING PRODUCTS
Time-to-clinic and time-to-market are two key factors in successful biopharmaceutical development.
Capto L is an affinity chromatography medium for the process-scale capture of a broad range of antibodies and antibody fragments.
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.