Biosimilar App Notes & Case Studies

  1. 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.

  2. Aseptic Filling Solution Enhances Sterility Assurance for Pharma Manufacturer 11/21/2024

    Emergent BioSolutions upgraded its Winnipeg site with the Cytiva SA25 aseptic filling workcell to improve sterility assurance, product flexibility, and regulatory compliance for CGT manufacturing.

  3. Mobius® ADC Reactor Performance 10/22/2024

    Learn about a family of single-use ADC reactors that has been developed to offer a safer and more efficient ADC production method than traditional mixing systems and meet the industry's growing needs.

  4. 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.

  5. 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.

  6. Demonstrated Strength And Durability Of Ultimus® Film 5/12/2023

    Here, we outline the development of Ultimus® film and summarize the strength and robustness tests conducted in accordance with the American Society for Testing and Materials (ASTM).

  7. How To Successfully Isolate Your T Cells 10/7/2024

    Explore the results of a study focusing on the early stages of the CAR T cell workflow, specifically the initial washing of leukapheresis followed by the isolation of T cells.

  8. 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.

  9. Exosome Isolation By TFF And Size Exclusion Chromatography 3/6/2024

    Here, we demonstrate a scalable workflow for the isolation of exosomes that combines tangential flow filtration for the concentration of exosomes followed by gentle size exclusion chromatography.

  10. Media And Buffer Mixing Using The Xcellerex™ Magnetic Mixer 6/19/2024

    A common requirement for media and buffer preparation in biopharma processing is powder-liquid mixing. Review the performance of a 3000 L single-use mixing system for preparing aqueous solutions.