Biosimilar App Notes & Case Studies

31. 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.

32. 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.

33. Lentiviral Vector Upstream Process 12/12/2025

    Scalable lentiviral vector production is moving beyond adherent systems. Learn how streamlined workflows enable linear scale-up in stirred-tank bioreactors for cost-effective gene therapy manufacturing.

34. Developing A Large-Scale Tangential Flow Filtration Process 5/13/2024

    Discover a process that can be modified to fit your downstream process and serves as a complete solution for concentration and diafiltration.

35. 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.

36. A Sustainable Future: Phasing Out Animal Testing 1/14/2026

    Discover a practical roadmap for replacing animal tests with advanced molecular methods, as well as how regulatory updates and innovative technologies are shaping a sustainable future.

37. 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.

38. 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.

39. 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.

40. 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.