DOWNSTREAM PROCESSING FEATURED ARTICLES
America’s biopharmaceutical research companies are testing 981 medicines and vaccines to fight the many types of canceraffecting millions of patients worldwide, according to a report released today by the Pharmaceutical Research and Manufacturers of America (PhRMA).
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Theratechnologies Secures US Patent For Its Novel Peptide TH1173
Theratechnologies Inc. (TSX:TH)(NASDAQ:THER) today reported that the US Patent and Trademark Office (USPTO) has granted a patent (US Patent No. 8,361,964) for its second generation growth-hormone releasing factor (GRF) peptide, TH1173, providing for patent protection beyond 2030.
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Thermo Fisher Scientific And Immundiagnostik Collaborate To Develop Mass Spectrometry-Based Clinical And Research Tools
Thermo Fisher Scientific, Inc., the world leader in serving science, and Immundiagnostik AG today announced a collaboration to develop novel mass spectrometry-based assays for qualitative and quantitative analysis of proteins and peptides. The goal is development of commercial assays to be widely applicable in research and routine clinical analysis.
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Lonza And OncoMed Pharmaceuticals Sign A Process Development And Manufacturing Collaboration And Multi-Product GS License Agreement For Anti-Cancer Therapeutics
Lonza, a global leader in biological manufacturing and OncoMed Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company dedicated to improving cancer treatment, announced recently an agreement for the development and manufacture of OncoMed’s pipeline of anti-cancer stem cell therapeutics.
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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SciLog - Creating Advanced Biotech Equipment With Mettler Toledo For nearly two decades, SciLog, Inc. has been dedicated to creating revolutionary single-use purification systems and disposable sensor technologies.
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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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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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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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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
DOWNSTREAM PROCESSING PRODUCTS
Mixed-mode chromatography resin is a top tier selection for the manipulation, purification and handling of molecules; providing an unmatched level of separation properties and resolution. The combination of cation exchange resin and metal affinity resin properties, allows multimodal chromatography to provide an access route for biomolecules to separate and the use of alternative chromatographic methods make these biomolecules seem homogenous.
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.