Biosimilar App Notes & Case Studies

  1. 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).

  2. Characterization Of Host Cell Proteins By Liquid Chromatography - Mass Spectrometry 2/26/2024

    Explore an established liquid chromatography – tandem mass spectrometry (LC-MS/MS) method for characterization of residual HCPs in monoclonal antibody (mAb) products.

  3. Determining RNA Integrity And Purity By Capillary Gel Electrophoresis 6/30/2023

    To ensure mRNA product quality, it's important to confirm the integrity of the RNA. Examine the results of a study challenging the performance of the CGE method in assessing mRNA integrity and purity.

  4. AAV Process Intensification Using High Salt Lysis And Salt Tolerant Endonuclease 3/25/2024

    In the production of adeno-associated virus (AAV) vectors, cell lysis involves challenges addressed through high salt concentrations and a salt-tolerant endonuclease, enhancing titer and infectivity.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.