Biosimilar App Notes & Case Studies

  1. 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.

  2. 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.

  3. 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.

  4. mRNA Manufacturing With Fed-Batch In Vitro Transcription 2/13/2026

    A milliliter-scale approach to IVT optimization reveals how controlled feeding, precise pH management, and real-time monitoring can boost mRNA yield and streamline scale-up to larger bioreactor volumes.

  5. Discover A System That Can Be Used With Various Cell Culture Media 6/19/2026

    Evolving CAR T cell therapies are raising the bar for manufacturing. Advances in cell expansion and the shift to serum-free media are redefining how scalable, future-ready processes are designed.

  6. Microbial Recovery And Flow Performance With Membranes 2/25/2026

    Compare membrane materials and pore sizes to assess their impact on flow rate and microbial recovery. See how fast filtration and ≥90% organism recovery offer guidance for selecting reliable membranes.

  7. Can Your Biopharma Team Keep Unplanned Downtime At Bay? 3/10/2026

    Learn how teams reduce downtime, strengthen compliance, and respond quickly to equipment issues through proactive maintenance, smart spare parts planning, and digital troubleshooting tools.

  8. Performance Of Mobius® Bag Assemblies With Ultimus® Film In Truck Shipping Simulation Test 10/29/2024

    Explore findings from a study testing Mobius® single-use bags under rigorous shipping conditions, demonstrating the suitability for transporting various liquid volumes while preserving their integrity.

  9. 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.

  10. 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.