Biosimilar App Notes & Case Studies

  1. 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.

  2. 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.

  3. 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.

  4. Get Full Control Of Your T Cell Isolation 3/25/2024

    This study demonstrates the automated magnetic isolation of CD4/CD8+ cells from fresh or frozen leukapheresis using a functionally closed cell processing system paired with a modular application.

  5. Accelerating The Development And Optimization Of Cell Culture Media 10/18/2024

    Here, we outline the use of a microbioreactor for the rapid screening and optimization of media formulations for perfusion processes, and its role in predicting the performance of larger-scale bioreactors.

  6. 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.

  7. 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.

  8. Raman As A Quality Control Tool For Cell Culture Media Preparation 6/14/2024

    Explore study results demonstrating how Raman technology easily differentiates between media with similar compositions and detects potential preparation errors that other analysis methods might miss.

  9. Multi-Attribute Method Analysis In Biopharmaceutical Development 2/26/2025

    Analytics is a crucial element in biopharmaceutical development and manufacturing. Discover how Multi-Attribute Method (MAM) revolutionizes analytics to enhance quality control and regulatory compliance.

  10. Process Validation Considerations 6/13/2024

    Process validation is a crucial step for successful registration and commercial manufacturing. Learn how to determine the right timing and properly apply a risk-based approach.