Biosimilar App Notes & Case Studies

1. Cell-Free Modeling Approach For Efficient Cell Culture Monitoring 6/14/2024

   Learn about a novel cell-free modeling method for the efficient monitoring of cell cultures that has significant advantages over traditional approaches.

2. 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.

3. Oligonucleotide Purification And Synthesis 1/27/2026

   Examine how a 21‑mer oligo was synthesized and purified through systematic resin screening, method optimization, and successful scale‑up to build reliable, high‑purity chromatography workflows.

4. 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.

5. 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.

6. 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.

7. 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.

8. Cell Culture Media Filtration: Evaluating Cell Culture Performance 10/23/2025

   Cell culture performance remained consistent across PES and PVDF filters, even under worst-case filtration conditions. Discover a practical framework for evaluating membrane impact on CHO cell growth.

9. 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.

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.