Biosimilar App Notes & Case Studies

  1. Seamless Process Transfer Using An In Silico Bioreactor Scaling Tool 3/24/2025

    Transferring cell cultures between scales is challenging and error-prone. Discover a bioreactor scaling software that predicts optimal settings to enable efficient scale-up and progression to clinical studies.

  2. Seed Train Intensification Using High Cell Density Cryopreservation 8/11/2025

    Streamline your upstream bioprocessing with seed train intensification. Discover how high cell density cryopreservation reduces scale-up time, boosts consistency, and enhances manufacturing flexibility.

  3. A Transient Cell Line To Produce rAAV With Low-Level hcDNA Encapsidation 1/15/2025

    Discover the ability of a novel HEK293 suspension cell line for efficient and scalable rAAV production across various serotypes with low encapsidated host cell DNA levels.

  4. 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.

  5. Extractables In Single-Use Systems Used In ADC Manufacturing 9/23/2024

    To address concerns about using organic solvents in the ADC process, extractables studies were conducted on a disposable chromatography column housing and two different disposable flow paths.

  6. 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.

  7. Non Animal Origin Squalene For High-Risk Applications 7/21/2025

    Explore an ethical and sustainable alternative to shark-derived squalene that is backed by robust data to deliver identical performance in vaccine formulations without environmental compromise.

  8. Selecting A Platform Filter For High Concentration mAbs 4/9/2025

    Read more about how Fujifilm Diosynth Biotechnologies evaluated a prime filter with challenging simulant solutions and how the experimental data confirmed superior performance, which demonstrated twice the throughput.

  9. 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.

  10. Raman As A Quality Control Tool For Cell Culture Media Preparation 6/14/2024

    Explore study results demonstrating how Raman technology easily differentiates between media with similar compositions and detects potential preparation errors that other analysis methods might miss.