DOWNSTREAM PROCESSING FEATURED ARTICLES
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) for its IgG Antibody to herpes simplex virus (HSV) types 1 and 2 assays for use on cobas® modular platforms. The tests are intended for use with sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-1 and HSV-2 infection.
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New Objective And McKinley Scientific Announce A Strategic Co-Marketing Collaboration In High-Performance LC-MS
McKinley Scientific, LLC and New Objective, Inc. recently announced that they have entered into a strategic co-marketing and development agreement designed to enable and expand key applications for delivery of high-performance LC-MS systems.
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![Dr Reddy]( "Dr. Reddy's Laboratories Ltd. And Merck Serono Announce Collaboration To Develop And Commercialize Biosimilars")
Dr. Reddy's Laboratories Ltd. And Merck Serono Announce Collaboration To Develop And Commercialize BiosimilarsDr. Reddy’s Laboratories Ltd. [NYSE:RDY] and Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today a partnership to co-develop a portfolio of biosimilar compounds in oncology, primarily focused on monoclonal antibodies (MAbs). The partnership covers co-development, manufacturing and commercialization of the compounds around the globe, with some specific country exceptions.
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RainDance Technologies And CLC Bio Collaborate To Develop Specialized Software Solutions For Targeted Resequencing RainDance Technologies and CLC bio recently announced a partnership to develop specialized software for the analysis of targeted resequencing data generated by workflows incorporating RainDance’s Sequence Enrichment Solution and next-generation DNA sequencing platforms.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
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USP <787> Small Volume Testing With Liquid Particle Counters
By their very nature, biological therapeutics are not only expensive to manufacture but are often produced in small volumes.
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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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Global Biochemical Profiling For Bioprocess Optimization
It is widely understood that the production phase of bioprocessing can have a significant impact on the overall profitability of the biopharmaceutical.
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Important Considerations For Implementing A Single-Use Biomanufacturing Strategy
Recent trends in biomanufacturing technology and the biopharmaceutical market are supporting the increased adoption of single-use (SU) manufacturing systems. On the demand-side, the biopharma industry is focusing on niche and rare diseases with smaller patient populations, resulting in the need for smaller, more agile biomanufacturing capacity. By Jodi M. Zobrist and Nicole W. O'Brien, Ph. D., Gallus Biopharmaceuticals, LLC
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Continuous Harvesting Of Extra-Cellular Proteins From Mammalian Cell Cultures Utilizing Small-Scale Perfusion
The use of a small-scale cell culture system not only maximizes the production of valuable protein but also avoids the high capital cost associated with system scale-up. Continuous harvesting can provide significant improvements in protein yields when compared to those of typical batch operations.
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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.
DOWNSTREAM PROCESSING PRODUCTS
Amsphere™ A3 is a next generation Protein A chromatography resin for advanced protein separation in downstream processing of therapeutic antibodies manufacturing. With high capacity resin, Amsphere™ A3 has an overall improved process robustness, flow characteristics, optimized impurity removal, productivity and resin lifetime.
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.