DOWNSTREAM PROCESSING FEATURED ARTICLES

3 Critical Considerations For Cell Therapy Manufacturing 3 Critical Considerations For Cell Therapy Manufacturing

While autologous cell therapies offer promise in the way of patient treatment, manufacturing them is a complex process requiring thorough understanding of the cell type(s) that a company will be providing as therapy. When it comes to ensuring the successful manufacturing of a cell therapy drug, Ross Tubo, chief scientific officer at Vericel Corporation, says there are three critical areas where particular attention should be paid.

DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES

  • 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.

  • Monoclonal Antibody Purification Platform Using High-Capacity Protein A And Mixed-Mode Chromatography

    The first step in purification of an important class of therapeutic proteins, the polyclonal or monoclonal antibodies (mAbs), is their capture from plasma or tissue culture supernatants. Protein A–based media are by far the most common class of affinity products used for this purpose.

  • 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

  • Proven Long Life Lasers™ In Optical Particle Counters Optical particle counters (OPC) utilize light illumination and extinction to determine the presence, size, number and/or concentration of particles. Particles are typically suspended in a fluid or air, which flow through the volume that is illuminated and viewed by the detection system.
  • Managing Cell-Based Potency Assays: From Development To Lifecycle Maintenance

    Characterization of a biological product — which includes the determination of physicochemical properties, biological activity, immunochemical properties, purity and impurities — is necessary to establish the safety and efficacy profile of a given product (ICH Q6B).  By Dr. Weihong Wang, manager, Molecular and Cell Biology, Eurofins Lancaster Laboratories

DOWNSTREAM PROCESSING PRODUCTS

STERIS Isomedix Services provides contract sterilization and microbial control services for single-use bioprocess systems used in the production of biopharmaceuticals and vaccines.

Hydrophilic media and depth filters. Cellulosic, Diatomaceous earth + cellulose, GF, polyproylene and nano fiber disposable capsules or cartridges. For clarification, prefiltration or to protect columns. Many different inlet / outlet connections, with or without vents and drains. SIP / Autoclavable. Specify when gamma stability is required.

The Avanti® J-HC High Capacity Centrifuge provides you with a complete solution for batch bioprocessing. A maximum of 9 Liters can be spun at speeds of 5,000 rpm and 7,480 x g for greater sample throughput. This allows processing of up to 36 Liters per hour when harvesting bacteria. Enhanced operator safety is provided with disposable HarvestLine System Liners.

PRP-X300 is a polymeric column packing for the separation of alcohols and organic acids.

BalanCD® CHO Feed 2 is a chemically-defined protein-free feed medium designed to be added as a fed-batch supplement to promote cell growth and increase process yields of antibodies and recombinant proteins.

In an effort to push science forward, WHEATON is manufacturing  a new line of membrane driven flasks for high density cell culture. The flasks are designed to enhance small scale bio-production for antibody and protein generation.

Time-to-clinic and time-to-market are two key factors in successful biopharmaceutical development.

Agilent's GeneSpring GX software provides powerful, accessible statistical tools for fast visualization and analysis of transcriptomics, genomics, proteomics and metabolomics data.

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.

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