Biosimilar App Notes & Case Studies

  1. Cell Retention Technology And Specialized Cell Culture Media 8/11/2025

    Explore how perfusion technology is transforming upstream bioprocessing by boosting productivity, reducing costs, and enabling process intensification while overcoming cell retention challenges.

  2. Review Of Applications And Processes In Fixed-Bed Bioreactors 5/6/2024

    Gain insights and guidelines for developing new processes in this review evaluating publications on the applications of single-use, scalable fixed-bed bioreactors for adherent cell culture processes.

  3. 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.

  4. 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.

  5. Overcoming The Solubility Challenges Of Antibody-Drug Conjugates 6/3/2024

    Discover a chito-oligosaccharide that significantly improves the solubility of antibody-drug conjugates (ADCs) when included in the linker-payload construct.

  6. Improving Bioprocess Monitoring And Control With Multivariate Data Analysis 12/9/2024

    Learn about multivariate data analysis (MVDA) techniques, like PCA and PLS, that enable near real-time monitoring, prediction, and optimization of biomanufacturing processes.

  7. 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.

  8. Accelerating Bulk Harvest Testing Using A CHO Animal Origin Free Virus Panel 10/19/2023

    Here, we describe the design and performance of a degenerate PCR-based approach to broad virus screening that can be used in testing bulk harvest material derived from CHO cells.

  9. 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.

  10. Sterilizing Grade Filter Performance With Biologic Drugs 3/11/2024

    Examine the throughput performance of sterilizing grade filters across moderate-to-high concentrations of mAbs and immunoglobulins as well as how filter selection can impact your process.