Biosimilar App Notes & Case Studies

1. 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.

2. 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.

3. Adapting Single-Use Chromatography To Manufacturing Scale 5/16/2024

   Explore strategies for accommodating the ever-increasing upstream titers and volumes to prevent downstream purification from becoming a bottleneck.

4. 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.

5. A Synergy Of Excellence: Partnership During Unprecedented Times 5/28/2024

   Learn how a partner with the right experience and capabilities is crucial to support accelerated GMP manufacturing and ensure novel vaccines and therapeutics receive regulatory approval.

6. 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.

7. 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.

8. Lentiviral Vector Production Using Single-Use Bioreactors 5/6/2024

   Here, we outline a scalable and robust upstream process developed for LVV production of HEK293T cells and demonstrate how to expand HEK293T suspension cells.

9. 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.

10. 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.