Biosimilar App Notes & Case Studies

  1. 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.

  2. Accelerating The mAb Formulation Process 5/7/2024

    Learn about a one-step process that was developed to streamline formulation, effectively reducing timelines from approximately 14 weeks to 8 weeks for this critical step.

  3. 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.

  4. Real-Time And In-Line Raman Spectroscopy For Glycan Quality Analysis 6/14/2024

    This study details the use of in-line Raman spectroscopy to monitor mAb glycan profiles within a production bioreactor, highlighting its potential for automation and customization.

  5. 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.

  6. Implementation Of Multi-Column Chromatography Systems 4/4/2025

    Discover how a multi-column chromatography system enhances resin utility and enables continuous bioprocessing with minimal surge tankage for agile multi-product facilities.

  7. Enabling Accelerated Raman Model Calibration For Real-Time Monitoring 6/14/2024

    Raman spectroscopy is a key component of a PAT strategy. Evaluate an innovative workflow designed to streamline the integration of an in-line Raman analyzer for bioreactor applications.

  8. Optimizing The Formulation For A Monoclonal Antibody 8/21/2023

    An emerging biotech company sought help developing a formulation for a monoclonal antibody. Explore how MilliporeSigma delivered an optimized formulation within an aggressive timeline and budget.

  9. Developing A Large-Scale Tangential Flow Filtration Process 5/13/2024

    Discover a process that can be modified to fit your downstream process and serves as a complete solution for concentration and diafiltration.

  10. Adapting Single-Use Chromatography To Manufacturing Scale 5/16/2024

    Explore strategies for accommodating the ever-increasing upstream titers and volumes to prevent downstream purification from becoming a bottleneck.