Biosimilar App Notes & Case Studies

1. 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.

2. Packing MabSelect™ And MabSelect SuRe™ Resins Using Verified Methods 12/6/2024

   Proper packing of MabSelect resins is crucial for efficient chromatography. Verified methods ensure stability, optimal flow, and reproducibility across scales using automated tools.

3. Scalable rAAV9 Production Using Advanced Cell Lines And Bioreactors 6/15/2026

   Progress in gene therapy manufacturing is being driven by improved cell line performance and scalable bioprocessing. See how high-density growth helps streamline development to larger-scale production.

4. 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.

5. Evaluating Antibody Fragment Purification Using VH3 Resin 5/22/2026

   Explore how VH-domain targeting enables efficient purification of VH3 antibody fragments and bispecific formats, with strong recoveries and flexible wash conditions that support improved purity.

6. Evaluation Of Extractables And Physical Compatibility Of The Mobius® ADC Reactor Single-Use Components For ADC Manufacturing 10/29/2024

   Explore study results evaluating the physical compatibility of single-use components in the Mobius® ADC Reactor and the level of extractables when exposed to dimethyl sulfoxide and dimethyl acetamide.

7. 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.

8. 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.

9. Developing CAR T Therapies With A Cell Therapy Manufacturing Platform 6/19/2026

   Advances in CAR T cell engineering are expanding clinical potential, but manufacturing complexity limits scale. Integrated, automated workflows offer a path to consistent and efficient production.

10. Scale-Up Of AAV Production In Fixed-Bed Bioreactors 3/31/2026

    Consistent AAV production is critical for manufacturing. See how aligned strategies deliver comparable cell growth, metabolic trends, and rAAV5 titers from development through production.