Biosimilar App Notes & Case Studies

1. 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.

2. Media And Buffer Mixing Using The Xcellerex™ Magnetic Mixer 6/19/2024

   A common requirement for media and buffer preparation in biopharma processing is powder-liquid mixing. Review the performance of a 3000 L single-use mixing system for preparing aqueous solutions.

3. Enhanced Flow Kit Performance With Leak And PUPSIT Testing 1/13/2026

   Sterile drug filtration demands rigorous integrity testing to prevent contamination. Learn how PUPSIT and in situ leak testing strengthen compliance with EU GMP Annex 1 and ensure reliable manufacturing.

4. Optimization And Scale-Up Of A Plasmid DNA Production Process 9/30/2025

   Optimizing pDNA production in E. coli requires strategic media selection and scale-up planning. Explore a study that identifies ideal conditions for high-yield manufacturing.

5. 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.

6. Seed Train Intensification Using High Cell Density Cryopreservation 8/11/2025

   Streamline your upstream bioprocessing with seed train intensification. Discover how high cell density cryopreservation reduces scale-up time, boosts consistency, and enhances manufacturing flexibility.

7. Optimized Product Recovery Using The Drug Product Filtration System 1/12/2026

   Explore strategies to maximize drug product recovery during sterile filtration, minimize hold-up volume, and reduce dilution after PUPSIT to ensure higher yield, improved efficiency, and less waste.

8. Virus Retention Performance Under Diverse Processing Conditions 11/14/2025

   Virus filtration is robust across a wide range of process parameters, including high protein concentration and flow decay. Discover how retention relies on size exclusion to simplify risk assessment.

9. 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   Upgrading outdated filling systems is essential for meeting future production demands and regulatory standards.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.

10. 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.