DOWNSTREAM PROCESSING FEATURED ARTICLES
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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Major Cancer Protein Amplifies Global Gene Expression, NIH Study Finds
Scientists may have discovered why a protein called MYC can provoke a variety of cancers. Like many proteins associated with cancer, MYC helps regulate cell growth.
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AB SCIEX And Indigo Team Up To Accelerate Adoption Of Next-Generation Mass Spectrometry For Clinical Research, Forensic Toxicology And Clinical Trials AB SCIEX and Indigo BioSystems recently announced an agreement to jointly market mass spectrometry solutions that streamline data acquisition and automate data review to ensure high quality results in clinical research and forensic toxicology as well as pre-clinical and clinical trials of new drugs.
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Thallion And LFB Terminate Shigamabs Collaboration
Thallion Pharmaceuticals Inc. (TSX-V: TLN) ("Thallion") and LFB Biotechnologies ("LFB") today announced that they have reached an agreement on the termination of their Development and Licensing Agreement related to Thallion's Shigamabs® program.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
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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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Efficiencies Of Natural Convection In Passive Pallet Shippers
Bulk transportation of temperature sensitive pharmaceuticals and biologics has become a common practice due to complex global supply chains. By Iftekhar Ahmed, Ben VanderPlas, and Stu Krupnick
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Met One Sensors Resistant To Vaporous Hydrogen Peroxide (VHP) Pharmaceutical manufacturers often require an aseptic production environment to minimize the presence of microbes and their potential contamination of the manufactured product.
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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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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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Applications And Integration Of Hydrogen Peroxide Vapor For Biotech/Bioprocess
The increase in size and scale of bio-processing is presenting a new challenge. Traditional methods of sterilisation, to maintain clean facilities, are becoming difficult to deploy in a controlled and regulatory compliant way. By Richard Lucas, Ph.D., Bioquell UK Ltd.
DOWNSTREAM PROCESSING PRODUCTS
CHT is a leading purification medium of biomolecules in today’s demanding downstream process industry. Its mixed-mode support offers unique selectivities and often separates biomolecules that appear homogeneous with other chromatographic methods. The diverse binding capabilities of CHT for host cell proteins, leached protein A, antibody dimers and aggregates, nucleic acids, and viruses allow its use at any stage from initial capture to final polishing.
A proven method for confirming protein purity and yield without the need for gel staining steps. Stain-free gels provide visual confirmation of protein purity and yield by gel electrophoresis in less than 30 minutes. Stain-free technology is perfect for drug discovery, drug development, and method development for preclinical research.
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.