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. 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.

  3. Optimized Product Recovery Using The Drug Product Filtration System 1/12/2026

    Explore strategies to maximize drug product recovery during sterile filtration, minimize hold-up volume, and reduce dilution after PUPSIT to ensure higher yield, improved efficiency, and less waste.

  4. A Sterilizing-Grade Membrane For Efficient Filtration Of Biologics 7/7/2026

    Higher flow rates and a smaller process footprint can create meaningful gains across sterile filtration steps. Explore the performance data and where efficiency improvements may be possible.

  5. Process Intensification Through Downstream Connectivity 7/1/2026

    See how downstream steps can be linked into a coordinated workflow, with practical insight into automation, equipment integration, and process control for building a more efficient strategy.

  6. Cell Culture Media Mixing In A Benchtop Single-Use Mixer 11/13/2025

    Explore how efficient powder-liquid mixing and sterile filtration preserve media integrity and support reproducibility in biopharmaceutical workflows, with promising scalability for larger-volume applications.

  7. Comparing Process Development Approaches For Recombinant Proteins 2/26/2026

    Explore how adding a traceless tag enables streamlined affinity purification for recombinant proteins, and how this approach compares with a conventional process in development time, recovery, and purity.

  8. 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.

  9. 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.

  10. Protect Your Columns And Your Peaks 2/24/2026

    Learn how thoughtful filter selection can protect LC systems, improve protein recovery, and support reliable chromatographic results with key performance data and solvent compatibility insights.