Bioprocessing Application Notes & Case Studies

  1. Achieve Continuous Supply Of Drug Treatment For Study Requirements

    A small sized pharmaceutical company was approaching the final phases of a large phase III global multiple treatment arm oncology study that involved comparator drug. The study criteria required the client to provide study medication to patients active at the conclusion of the study until the drug would be commercially available, when it could then be prescribed to patients continuing treatment.

  2. Method For Optimizing mAb Polishing Using CMM HyperCel™ Mixed-Mode Cation Exchanger

    mAbs are produced for a number of therapeutic applications. However, mAbs are not a homogeneous family of products. Each mAb is unique, based on its isoelectric point, hydrophobicity and ability to aggregate. Additionally, the contaminant HCP content is process-dependent.

  3. Scale Up/Down Purification Study Using Mustang® XT Acrodisc® Membrane Adsorber

    Membrane chromatography is now routinely implemented in many large scale biotech processes to remove contaminating host cell proteins, DNA and viruses at high flow rate.

  4. A Disposable, Easy To Use And Effective Polishing Step In Monoclonal IgG1 Production

    Mustang Q membrane chromatography was evaluated as a polishing step following protein A affinity and cation exchange chromatography to remove residual host cell DNA during a Monoclonal antibody (MAb) purification process at 250 L cell culture production-scale. 

  5. The Benefits Of Using Mixed-Mode Chromatography Sorbents In A MAb Purification Process

    The benefits of the unique selectivity and chemical stability offered by mixed-mode chromatography for the purification of monoclonal antibodies (MAbs) are well established. Rapid determination of optimum operating conditions earlier in process development maximizes the value of these industrial adsorbents.

  6. Large Scale Expansion And Differentiation Of Human Mesenchymal Stromal Cells

    Thermo Scientific™ Nunclon™ Delta treated Thermo Scientific™ Nunc™ Cell Factory™ systems is an effective format for the easy and rapid expansion of hMSCs. The Nunclon Delta surface is a fully synthetic chemical surface available with many options of sizes, shapes and surface area. hMSCs were removed from liquid nitrogen and plated directly onto the surfaces to be evaluated. T-25 cell culture flasks were used to determine the optimal seeding density prior to expansion of hMSC on larger formats.

  7. Characterization And Engineering Performance Of The Allegro™ STR 2000 Single-Use Stirred Tank Bioreactor

    Stirred tank reactors (STRs) have become the prevalent choice for the commercial manufacture of therapeutic proteins from suspension cell lines. Process performance in this scalable family of bioreactors is strongly influenced by the efficiency of bulk fluid mixing and the oxygen mass transfer coefficient (kLa).

  8. Characterization And Engineering Performance Of The Allegro™ STR 1000 Single-Use Stirred Tank Bioreactor

    In this application note the performance of the Allegro STR 1000 bioreactor in terms of mixing, mass transfer (oxygen mass transfer and CO2 stripping efficiency) and temperature control is demonstrated. The Allegro STR 1000 bioreactor is a geometric scale-up of the Allegro STR 200 bioreactor and has been designed to provide scalable engineering parameters. Therefore, the comparison of the mixing and mass transfer between the two bioreactors is presented.

  9. Comparison Of CHO Cell Cultivation And mAb Production In Pall XRS 20 And Conventional Rocker Type Single-Use Bioreactors

    The Pall XRS 20 Bioreactor System is a new single-use bioreactor system suitable for applications ranging from general life sciences research to seed train operations and small scale production at the 2 to 20 liter scale. It features a 3D rectangular biocontainer that is rocked across two independent axes perpendicular to one another. These features allow for significant improvements in mixing and kLa when compared with a conventional rocking bioreactor that features a 2D “pillow” biocontainer that rocks across a single axis.

  10. VERO Cultivation In Nunc™ High Density Cell Factory™ System Protocol

    This protocol was developed to validate the performance of the Thermo Scientific™ Nunc™ High Density Cell Factory™ System (HDCF) for the culturing of VERO cells. The protocol includes reference to the use of standard Nunc Cell Factory systems as controls. It is a recommendation. This protocol may be used as a reference or offer options for optimizing the performance of established protocols.