Biosimilar App Notes & Case Studies

1. Accelerate Process Development With Automated Aseptic Sampling 5/6/2024

   Discover how implementing automated sampling systems enabled Takeda Pharmaceuticals to achieve new efficiencies in process development.

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   Upgrading outdated filling systems is essential for meeting future production demands and regulatory standards.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

3. 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.

4. Real-Time And In-Line Raman Spectroscopy For Glycan Quality Analysis 6/14/2024

   This study details the use of in-line Raman spectroscopy to monitor mAb glycan profiles within a production bioreactor, highlighting its potential for automation and customization.

5. Efficient Protein Purification Strategies 2/24/2026

   Examine two rapid, high‑throughput strategies for small‑scale protein separation, using either multimodal resins or ion exchange membranes to achieve efficient, low‑volume purification.

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. 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.

8. Multi-Column Chromatography For Efficient Polishing Purification 1/14/2026

   Boost downstream efficiency with multi-column chromatography for polishing to achieve higher productivity, reduced resin costs, and automated operation while maintaining purity and recovery.

9. 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.

10. mRNA Manufacturing With Fed-Batch In Vitro Transcription 2/13/2026

    A milliliter-scale approach to IVT optimization reveals how controlled feeding, precise pH management, and real-time monitoring can boost mRNA yield and streamline scale-up to larger bioreactor volumes.