Biosimilar App Notes & Case Studies

  1. 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.

  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. 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. 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.

  5. Improving Bioprocess Monitoring And Control With Multivariate Data Analysis 12/9/2024

    Learn about multivariate data analysis (MVDA) techniques, like PCA and PLS, that enable near real-time monitoring, prediction, and optimization of biomanufacturing processes.

  6. Accelerating The mAb Formulation Process 5/7/2024

    Learn about a one-step process that was developed to streamline formulation, effectively reducing timelines from approximately 14 weeks to 8 weeks for this critical step.

  7. 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.

  8. Optimizing TFF And SPTFF For High-Concentration mAb Formulations 4/9/2025

    Discover the critical role of formulation buffer composition in stabilizing monoclonal antibodies during tangential flow filtration, a process involving ultrafiltration and diafiltration under high pressure and shear forces.

  9. 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.

  10. Automated Cell Washing And Formulation In CAR T Cell Therapy Manufacturing 6/14/2024

    Explore data collected from a study utilizing healthy donors in a typical CAR T cell processing workflow without a transduction step from a cross-site validation study.