DOWNSTREAM PROCESSING FEATURED ARTICLES
Recently, the U.S. Food and Drug Administration released a copy of the FDA Form 483 issued to the New England Compounding Center (NECC). The FDA observed and has since confirmed contaminated products and listed a number of observations regarding conditions in the clean room at NECC’s Framingham, Mass. facility.
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Selecta Biosciences And Sanofi Sign Global Collaboration To Develop Antigen-Specific Immunotherapies For Up To Three Allergy Indications Based On Selecta's Synthetic Vaccine Particle Technology
Selecta Biosciences, Inc., a clinical-stage biopharmaceutical company developing a new class of synthetic vaccines and immunotherapies, recently announced that it has entered into a strategic global collaboration with Sanofi to discover highly targeted, antigen-specific immunotherapies for life-threatening allergies.
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![hard]( "Prospective Alzheimer's Drug Builds New Brain Cell Connections")
Prospective Alzheimer's Drug Builds New Brain Cell ConnectionsWashington State University researchers have developed a new drug candidate that dramatically improves the cognitive function of rats with Alzheimer’s-like mental impairment.
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Element Six And The University Of Warwick Announce Development Of New Boron-Doped Synthetic Diamond Electrode For Extreme Electroanalysis Sensing Applications
AT PITTCON 2013, Element Six, the world leader in synthetic diamond supermaterials and member of the De Beers Group of Companies, recently announced that it has engineered DIAFILM EA (Electroanalysis grade) in collaboration with The University of Warwick.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
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Comparability Of The Cell-Freeze® (Charter Medical) Freezing Bag To The Cryocyte™ (Baxter) Bag For Cryogenic Storage Of Human Hematopoietic Progenitor Cells Successful cryopreservation of hematopoietic progenitor cells (HPC) is dependent upon a number of factors, including the biopreservation media, freezing rates, and storage using sterile, cryogenically durable storage bags. The Cell-Freeze® cryogenic storage containers are 510(k) cleared for storage, preservation and transfer of hematopoietic progenitor stem cells (HPC’s). By Charter Medical, Ltd.
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![CrystalStructure]( "How CHT Ceramic Hydroxyapatite Works Application Note")
How CHT Ceramic Hydroxyapatite Works Application NoteCHT ceramic hydroxyapatite is a versatile chromatography support used for separation of biological molecules as diverse as polyclonal and monoclonal antibodies, antibody fragments, enzymes, nucleic acids, and membrane proteins. By Paul Ng, Jie He, and Andrew Cohen, Bio-Rad Laboratories, Inc., Hercules, CA 94547
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![DebottleneckingCartoon]( "Biomanufacturing Debottlenecking And Process Optimization")
Biomanufacturing Debottlenecking And Process OptimizationOptimizing biomanufacturing is particularly challenging because of variability and complexity associated with the sharing of finite and interdependent resources. By BIO-G
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Gemin X Pharmaceuticals: Finding A Drug's Mechanism Of Action
Gemin X, a pharmaceutical company focused on the discovery and development of advanced oncology
therapeutics, approached Metabolon to run a metabolism profile for one of their compounds—GMX1777. -
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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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
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.
Sartopure PP2 Cartridges were optimized for the wide range of prefiltration.
Capto L is an affinity chromatography medium for the process-scale capture of a broad range of antibodies and antibody fragments.
The S.U.F. is engineered for optimal oxygen mass transfer, mixing, and temperature control, and performs comparably to traditional stainless steel systems. Using traditional, fundamental engineering principles, scale-up and process development work is streamlined – offering you cost savings and efficiency.
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.
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.