Biosimilar App Notes & Case Studies

  1. Optimizing Virus Bank Manufacturing 8/16/2024

    Gain insight into two cases where clients were enabled to overcome obstacles during virus bank manufacturing.

  2. Virus Retention Performance Under Diverse Processing Conditions 11/14/2025

    Virus filtration is robust across a wide range of process parameters, including high protein concentration and flow decay. Discover how retention relies on size exclusion to simplify risk assessment.

  3. Accelerating The Development And Optimization Of Cell Culture Media 10/18/2024

    Here, we outline the use of a microbioreactor for the rapid screening and optimization of media formulations for perfusion processes, and its role in predicting the performance of larger-scale bioreactors.

  4. Determining The Power Numbers For A Single-Use Mixing System 6/19/2024

    In designing a mixing process for scale-up, the power number is a critical parameter. Explore the determined power numbers for a single-use mixer at various mixing speeds and fill levels.

  5. Getting CMC Right For Emerging Technologies 12/20/2023

    Establishing a chemistry, manufacturing, and controls strategy that proves a clinical program is tightly controlled and can address risk is critical to avoiding the pitfalls that stall many promising therapeutics.

  6. Using Automated Spinoculation For CAR T Cell Lentiviral Transduction 2/26/2024

    There is a growing demand for closed and automated lentiviral transduction steps in CAR T cell therapy workflows. Learn about a potential solution to address this unmet need.

  7. Optimizing TFF And SPTFF For High-Concentration mAb Formulations 4/9/2025

    Discover the critical role of formulation buffer composition in stabilizing monoclonal antibodies during tangential flow filtration, a process involving ultrafiltration and diafiltration under high pressure and shear forces.

  8. How To Successfully Isolate Your T Cells 10/7/2024

    Explore the results of a study focusing on the early stages of the CAR T cell workflow, specifically the initial washing of leukapheresis followed by the isolation of T cells.

  9. Bulk Filling Of Drug Substance | Accurate Aliquoting 4/24/2024

    Bulk filling drug substances in traditional facilities is often a lengthy, manual process where operators are relied upon to adjust pump controls to achieve accurate filling. This method, spanning multiple shifts, increases process risk through errors that can compromise accuracy.

  10. Improving Bioprocess Monitoring And Control With Multivariate Data Analysis 12/9/2024

    Learn about multivariate data analysis (MVDA) techniques, like PCA and PLS, that enable near real-time monitoring, prediction, and optimization of biomanufacturing processes.