DOWNSTREAM PROCESSING FEATURED ARTICLES
Refine Technology, LLC (Refine), the developer and worldwide supplier to the biotech industry of the ATF™ System, a best-in-class cell retention device, and Gallus BioPharmaceuticals, LLC (Gallus), the industry leading contract bulk biopharmaceuticals manufacturer, today announced a collaboration to optimize continuous cell culture processes.
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Combination Sterile Connections For Single-Use Applications
Gain insight into why combination connections are used in single-use bioprocessing and guidance on how single-use systems can be designed to integrate the combination connectors.
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Genetic Immunity Receives GMP Certification For In-House Manufacturing Facility
Genetic Immunity (OTCBB: PWRV) is pleased to announce the GMP approval of its manufacturing facility. The development of the GMP manufacturing process and the facility was financed from a $4 million grant received from the Hungarian Office for Innovation and Technology.
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Samsung Bioepis And MSD Enter Biosimilars Development And Commercialization Agreement
Samsung Bioepis Co., Ltd. and MSD, known as Merck in the United States and Canada, announced
today they have entered into an agreement to develop and commercialize multiple pre-
specified and undisclosed biosimilar candidates.
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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Chromatography Column Protection With 3M Purification LifeASSURE™ PLA Series Membrane Filters Protective, or guard, filters are often used in chromatography column purification steps to protect the column media from contaminants in the various fluids that come in contact with the column.
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White Paper: 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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Protein A Alternatives: Mixed Mode Resins For High Throughput mAb Feedstocks
Mixed mode resins can serve as an alternative to protein A in intermediate processing. Implementation of mixed mode resins can reduce water required for filtration and time for column loading.
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Single-Use Connections Advance Aseptic Processing
John Boehm discusses how single-use connections advance aseptic processing and create increased process flexibility and reliability while reducing costs.
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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.