Biosimilar App Notes & Case Studies

  1. Optimizing Virus Bank Manufacturing 8/16/2024

    Gain insight into two cases where clients were enabled to overcome obstacles during virus bank manufacturing.

  2. 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.

  3. 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).

  4. 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.

  5. Monitoring Bioprocesses In A Light Environment Using Raman Spectroscopy 6/14/2024

    Discover an advanced solution to facilitate the implementation of Raman technology at both laboratory and manufacturing scales in a normal light environment.

  6. Process Validation Considerations 6/13/2024

    Process validation is a crucial step for successful registration and commercial manufacturing. Learn how to determine the right timing and properly apply a risk-based approach.

  7. 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.

  8. CDMO Uses Robotic Gloveless Isolator For Advanced Therapeutics 4/28/2025

    CDMOs must innovate production architectures to meet the demands of advanced therapeutics to ensure a reliable supply and compliance. Discover how these approaches advance modern medicine and improve patient outcomes.

  9. Standardize Scale-Up And Reduce Time To Market With Mixing Cartridges 7/21/2023

    Despite the momentum of the RNA-LNP therapeutic market, significant manufacturing challenges remain. However, the right mixing could solve three of these key challenges regarding instrumentation.

  10. 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.