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PROTEIN A MEMBRANE PURIFICATION STRATEGIES
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The GORE Protein Capture Device with Protein A is a cutting-edge membrane-based tool designed to enhance the efficiency of protein purification processes. This application note explores the use of this device in performing rapid process development on 24 sample panels for cell line optimization, or mimic the rapid processing of 24 clones for drug discovery, leveraging its speed to complete the task in less than 8 hours.
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The objective of this study was to showcase the capability of an intensified, fully single-use downstream process for a fed-batch cell culture harvest producing a representative mAb at an industrial scale. Explore results demonstrating the CQAs established with the existing method were met and scale-up from lab-scale devices was successful.
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Comparability in both product quality and chromatographic process characteristics between a Protein A affinity capture membrane and a packed-bed resin reference was demonstrated using a set of proposed criteria. Product quality attributes and process impurities from a purified IgG1 monoclonal antibody cell culture harvest were comparable between Protein A resin and membrane affinity stationary phases, with the membrane demonstrating order-of-magnitude higher chromatographic productivity.
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During manufacturing, therapeutic antibodies encounter hydrodynamic forces and material contact surfaces that can affect protein stability and the likelihood of aggregation. Review results from a study aiming to identify hydrodynamic shear rate, cumulative shear stress, and likely Reynolds number values based on size and scale.
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COLD DURABLE DRUG SUBSTANCE PRIMARY PACKAGING STRATEGIES
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While logistics solutions like RFID tags and temperature sensors have become standard for tracking and monitoring bulk drug substances, the single-use storage containers that many manufacturers rely on fall short in ensuring product security. Explore new materials under consideration for single-use cold chain storage containers to improve durability.
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As the biologics market continues to grow, drug manufacturers are looking for packaging solutions that maintain integrity during processing and freezing, are easy to scale up to larger volumes, and remain robust throughout the temperature-controlled supply chain. Why are bags better than many other container choices?
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Although polymer bags are an excellent choice for cold chain use, not all polymer films perform the same way, even if their specifications rate them for use at low temperatures. Read why a full suite of application testing is necessary to determine whether a bag will hold up to all the rigors of handling and shipping at extremely cold temperatures.
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With each batch of cell and gene therapy product representing a wealth of lifesaving potential, one U.S.-based biopharmaceutical company needed the right packaging solution for its relatively new gene therapy applications. Learn about the single-use flexible freeze containers the company selected to meet their needs and the resulting positive impact.
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