Biosimilar App Notes & Case Studies

1. 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.

2. Performance Of Mobius® Bag Assemblies With Ultimus® Film In Truck Shipping Simulation Test 10/29/2024

   Explore findings from a study testing Mobius® single-use bags under rigorous shipping conditions, demonstrating the suitability for transporting various liquid volumes while preserving their integrity.

3. Accelerate Process Development With Automated Aseptic Sampling 5/6/2024

   Discover how implementing automated sampling systems enabled Takeda Pharmaceuticals to achieve new efficiencies in process development.

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. Determining The Power Numbers For A Single-Use Mixing System 6/19/2024

   In designing a mixing process for scale-up, the power number is a critical parameter. Explore the determined power numbers for a single-use mixer at various mixing speeds and fill levels.

6. Automation And Digital Solutions Can Help You Reach Your mRNA Manufacturing And Sustainability Goals 1/14/2025

   Explore how digital solutions help streamline mRNA manufacturing by reducing costs, improving efficiency, and supporting sustainability by creating paperless processes for emerging therapeutics.

7. Evaluation Of Extractables And Physical Compatibility Of The Mobius® ADC Reactor Single-Use Components For ADC Manufacturing 10/29/2024

   Explore study results evaluating the physical compatibility of single-use components in the Mobius® ADC Reactor and the level of extractables when exposed to dimethyl sulfoxide and dimethyl acetamide.

8. 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.

9. Reducing The Level Of Host Cell Proteins In The Bioreactor Harvest 10/20/2023

   Learn how MilliporeSigma helped a customer drastically reduce the level of HCPs in the bioreactor harvest prior to a production run to supply drug substance for a scheduled Phase 1 clinical trial.

10. Bulk Filling Of Drug Substance | Accurate Aliquoting 4/24/2024

    Bulk filling drug substances in traditional facilities is often a lengthy, manual process where operators are relied upon to adjust pump controls to achieve accurate filling. This method, spanning multiple shifts, increases process risk through errors that can compromise accuracy.