DOWNSTREAM PROCESSING FEATURED ARTICLES

Dr Reddy 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.

  • 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.

  • 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

  • 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. 

  • 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

  • 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

  • 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.

  • 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.

  • 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.

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.

Sartopure PP2 Cartridges were optimized for the wide range of prefiltration.

High volume labs require simple, durable solutions to their centrifugation needs. Beckman Coulter’s Allegra® Series general purpose, benchtop centrifuges serve the needs of these labs by saving time, offering ease-of-use, and providing reliable design for endurance under the most exacting standards.

Agilent’s Gene Expression Wash Buffers are optimized and validated for consistently reliable, high volume, post-hybridization processing.

CHT is a leading purification medium of biomolecules in today’s demanding downstream process industry. Its mixed-mode support offers unique selectivities and often separates biomolecules that appear homogeneous with other chromatographic methods. The diverse binding capabilities of CHT for host cell proteins, leached protein A, antibody dimers and aggregates, nucleic acids, and viruses allow its use at any stage from initial capture to final polishing.

Sani-Tech® Ultra represents the next generation in ultra-pure platinum-cured silicone tubing. Features like ultra-low extractables and longer pump life were engineered into Ultra by the experienced materials scientists of Saint-Gobain Performance Plastics to meet the stringent requirements of the biopharmaceutical market.

Cellulosic, polypropylene or glass fiber depth filter media clarify or retain agglomerates and macromolecules. Protect downstream membrane filters and columns. Multiple inlet / outlet connections including sanitary tri-clamp, hose barbs, quick connectors, elbows or NPT. Disc for small volume, up to full sized Cartridges and capsules for process scale operations.

ZenPure designs, mold-manufactures and injects its own filter components. Engineering, product development and filter production under ISO standards facilitate full quality audit and traceability to meet the highest industry standards. Validation support documentation is available for appropriate products.

Choose from ten fixed volume SoftGrip pipettes covering 0.2 µL to 1 mL. All pipettes have color-coded plunger buttons and labels for easy volume identification.

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.

Beckman Coulter's Randall Lockner, marketing manager for centrifugation, explains the highlights of the floor model ultracentrifuge, the Optima X Series.

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.

DOWNSTREAM PROCESSING INDUSTRY NEWS