DOWNSTREAM PROCESSING FEATURED ARTICLES

Samsung Bioepis And MSD Enter Biosimilars Development And Commercialization Agreement 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

  • Quality By Design In Biomanufacturing

    QbD is increasingly required in our industry, but there are still gaps in understanding how QbD applies to the biomanufacturing process.

  • 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

  • Agilent Microarray Grant Application Support White Paper This guide offers an overview of Agilent’s microarray and SureSelect product offerings with ordering details to assist researchers with the details of grant submission.
  • Turning Data Into Information

    As biopharmaceutical manufacturing has evolved from small-scale lab production in small flasks to massive commercial production in deep-tank bioreactors, an avalanche of production data has evolved to support it. From individual unit operation skids to distributed control systems and enterprise resource planning tools, biomanufacturing today is buried by the sheer quantity of data coming in from the manufacturing floor.

  • Determination Of kLa Values Of Single-Use Bioreactors

    Because single use bioreactors offered by  manufacturers vary in parameters critical for oxygen transfer, they are often not comparable to each other and to conventional glass and stainless steel vessels.

  • 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.
     

DOWNSTREAM PROCESSING PRODUCTS

A wide selection of ion exchange resin is available in various particle sizes, ionic forms, and purity ranges to offer a variety of purification solutions for process applications. Nuvia ion exchange resins are a family of best-in-class ion exchangers built with exceptionally high capacities and excellent purification capabilities, providing process developers more flexibility and higher productivity. The Macro-Prep are rigid macroporous hydrophilic resin meet the demands of process-scale applications. Chemically and mechanically stable, the resin operate well at low and medium pressures.

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.

This is an exciting platform technology for cell cultivation. It is a highly versatile process which permits great increases in cell and product concentrations as compared to Fed Batch processing.

ÄKTA avant™ is a preparative chromatography system designed for fast and secure development of scalable methods and processes.

Conductivity sensors measure the ability of a solution to conduct a current. The higher the concentration of ions in the solution, the higher the conductivity, which is measured in microSiemens (mS).

It spins volumes.

With six-liter capacity and an innovative range of rotors, carriers, and adapters, this versatile centrifuge can handle multiple high capacity applications. Ideal for bioprocessing and clinical and blood sample preparation, the J6-MI is the standard for quiet and convenient operation.

Cytiva provides filtration solutions and support for integrated bioprocessing applications at every step and every scale of the drug development, validation and manufacturing process.

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.

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