Biosimilar App Notes & Case Studies

  1. Fab Fragment Development And Manufacturing For Clinical Trials 6/12/2024

    Explore the outcomes of implementing an accelerated approach to process development and manufacturing for a project that was crucial for the future of Acticor Biotech and its therapeutic candidate.

  2. Cell-Free Modeling Approach For Efficient Cell Culture Monitoring 6/14/2024

    Learn about a novel cell-free modeling method for the efficient monitoring of cell cultures that has significant advantages over traditional approaches.

  3. Reducing The Level Of Host Cell Proteins In The Bioreactor Harvest 10/20/2023

    Learn how MilliporeSigma helped a customer drastically reduce the level of HCPs in the bioreactor harvest prior to a production run to supply drug substance for a scheduled Phase 1 clinical trial.

  4. Characterization Of Host Cell Proteins By Liquid Chromatography - Mass Spectrometry 2/26/2024

    Explore an established liquid chromatography – tandem mass spectrometry (LC-MS/MS) method for characterization of residual HCPs in monoclonal antibody (mAb) products.

  5. Bioreactor Scalability Supports Intensified Upstream Process Development 7/31/2023

    In this study, key parameters for the Mobius® 3 L Single-Use Bioreactor and the 50-2000 L Mobius® iFlex Bioreactor impeller designs were characterized. Learn about bioreactor scalability for intensified processes.

  6. 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.

  7. Accelerate Process Development With Automated Aseptic Sampling 5/6/2024

    Discover how implementing automated sampling systems enabled Takeda Pharmaceuticals to achieve new efficiencies in process development.

  8. Production Of A Highly Concentrated Monoclonal Antibody 10/4/2024

    The production of a highly concentrated monoclonal antibody requires many process steps. Discover how to achieve a final mAb concentration above 200 g/L while maintaining critical quality attributes.

  9. Optimizing Virus Bank Manufacturing 8/16/2024

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

  10. CDMO Uses Robotic Gloveless Isolator For Advanced Therapeutics 4/28/2025

    CDMOs must innovate production architectures to meet the demands of advanced therapeutics to ensure a reliable supply and compliance. Discover how these approaches advance modern medicine and improve patient outcomes.