DOWNSTREAM PROCESSING FEATURED ARTICLES
Dr. Reddy's Laboratories Ltd. And Merck Serono Announce Collaboration To Develop And Commercialize Biosimilars
Dr. 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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FDA Lifts Clinical Hold On Lpath's iSONEP
Lpath, Inc. (
OTCQB : LPTN), the industry leader in bioactive lipid-targeted therapeutics, reported that the FDA has lifted the clinical hold on iSONEP™, Lpath's anti-S1P monoclonal antibody that is being developed as a potential treatment for wet AMD and possibly other ocular disorders. -
Advanced BioScience Laboratories Awards Avid Bioservices HIV Vaccine Development And Manufacturing Contract
Avid Bioservices, a subsidiary of Peregrine Pharmaceuticals, Inc., today announced that it has been chosen by Advanced BioScience Laboratories, Inc. (ABL) to provide development and large-scale manufacturing services to support cGMP production of an HIV envelope protein, as a component of a preventive vaccine against HIV infection.
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Laser Spotlight Reveals Machine 'Climbing' DNA
The experiments, reported in this week's Science, use laser light to generate very bright patches close to single cells. When coupled with fluorescent tags this 'spotlight' makes it possible to image the inner workings of cells fast enough to see how the molecular machines inside change size, shape, and composition in the presence of DNA.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
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Continuous Biomanufacturing: 10 Reasons Sponsors Hesitate
The industry is abuzz with talk about continuous biomanufacturing (CB), and its virtues have been well described. Here we will look at some of the barriers or concerns perceived to limit its value to the industry. Justified or not, quite a few concerns have been expressed regarding the implementation of this new, rather disruptive technology.
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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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Efficiencies Of Natural Convection In Passive Pallet Shippers
Bulk transportation of temperature sensitive pharmaceuticals and biologics has become a common practice due to complex global supply chains. By Iftekhar Ahmed, Ben VanderPlas, and Stu Krupnick
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Examining Column Reproducibility During Method Development In Clinical Labs
In this study demonstrates how the HSS T3 stationary phase is a reliable stationary phase, as three batches made over a five-year span provide comparable results.
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Mammalian Virus Purification Using Ceramic Hydroxyapatite
Conventional techniques for mammalian virus purification produce variable quality, quantity, and significant loss of particle infectivity. We propose the chromatographic separation of viral particles of diverse sizes and from different families such as dengue, influenza, mouse hepatitis, adenovirus, poliovirus using CHT Ceramic Hydroxyapatite resin.
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Biomanufacturing Supply Chains
This white paper examines the major issues with biopharmaceutical supply chains and how to balance inventory and risk optimally in the network.