Biosimilar App Notes & Case Studies

1. Application Of A Dual Spiking Strategy In Viral Clearance Studies 2/3/2026

   Explore how an alternative spiking strategy can streamline viral clearance studies, reduce material demands, and maintain compliance while addressing the challenges posed by MLV and MMV.

2. Balancing Protein A Resin Cost, Performance, And Productivity 7/31/2025

   Optimizing input parameters like DBC, flow rate, and resin durability is key to boosting productivity in downstream bioprocessing. Discover how to tailor resin choices to meet your specific process requirements.

3. 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.

4. 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.

5. Ultra-Low Cross-Linked Microgel Purification 2/24/2026

   ULC microgel purification is often slowed by linear polymer contamination and limitations of centrifugation. Explore how hollow fiber TFF improves filtration efficiency and supports scalable processing.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.