Biosimilar App Notes & Case Studies

  1. Simplifying CHO Cell Line Genetic Stability Testing 4/11/2024

    Here, we describe the use of whole genome sequencing to perform a comprehensive assessment of genetic stability in clonally derived CHO cell banks using the Aptegra™ CHO genetic stability assay.

  2. Optimizing The Formulation For A Monoclonal Antibody 8/21/2023

    An emerging biotech company sought help developing a formulation for a monoclonal antibody. Explore how MilliporeSigma delivered an optimized formulation within an aggressive timeline and budget.

  3. 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.

  4. Alkaline Stability Of Modern Protein A Chromatography Resins 7/12/2023

    Explore results from a resin lifetime study with over 150 cycles, using clarified cell harvest in every cycle, which has been performed to evaluate the alkaline stability of three protein A resins.

  5. Scalability And Performance Of Single-Use Bioreactors 8/1/2023

    Here, we provide scalability data as a guide for process development and cross-scale performance expectations and characterize performance attributes of the impeller, spargers, Ultimus® film, and sensors.

  6. 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.

  7. AAV Full/Empty Capsid Separation Using Mechanistic Modeling 5/1/2023

    In this study, we used mechanistic modeling to investigate how AAV-resin interactions are affected when MgCl2 is used as an elution additive.

  8. COVID-19 Impact To Biological Drug Products Safety 6/13/2022

    Review currently available literature and our recommended COVID-19 virus detection test methods and susceptibility of common biological host cells to infection.

  9. Lipid Nanoparticle Compositional Analysis By UHPLC-CAD 6/30/2023

    Explore results generated from an internal study using a proprietary mRNA-LNP formulation and UHPLC-CAD, a powerful technique for the analysis of compounds that do not contain chromophores.

  10. Optimizing Recovery On The Sepax™ Cell Processing System 7/21/2022

    Using a model T-cell line, we demonstrate the impact of varying rinse volume, intermediate volume, and manual extraction parameters on overall cell recovery with a final product dose volume of 20 mL.