Biosimilar App Notes & Case Studies

  1. Automated PUPSIT For Drug Product Applications 1/13/2026

    Automated filtration systems streamline PUPSIT, leak testing, and integrity checks to ensure sterile drug product processing. Learn how these methods improve contamination control and compliance.

  2. 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.

  3. 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.

  4. Review Of Applications And Processes In Fixed-Bed Bioreactors 5/6/2024

    Gain insights and guidelines for developing new processes in this review evaluating publications on the applications of single-use, scalable fixed-bed bioreactors for adherent cell culture processes.

  5. Non Animal Origin Squalene For High-Risk Applications 7/21/2025

    Explore an ethical and sustainable alternative to shark-derived squalene that is backed by robust data to deliver identical performance in vaccine formulations without environmental compromise.

  6. 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.

  7. 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.

  8. 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.

  9. How To Successfully Isolate Your T Cells 10/7/2024

    Explore the results of a study focusing on the early stages of the CAR T cell workflow, specifically the initial washing of leukapheresis followed by the isolation of T cells.

  10. Customer Story: Emergent BioSolutions Enhances Aseptic Filling Process 1/9/2026

    Upgrading outdated filling systems is essential for meeting future production demands and regulatory standards. Learn how one manufacturer modernized its approach to ensure compliance and efficiency.