Biosimilar App Notes & Case Studies

1. 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.

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   Upgrading outdated filling systems is essential for meeting future production demands and regulatory standards.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

4. 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.

5. Integrated Services For Cell Line Preparation And Storage 10/8/2024

   Explore a comprehensive suite of services for the manufacture, characterization, and storage of cell banks as well as the advantages of working with an experienced partner.

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. Bulk Filling Of Drug Substance | Accurate Aliquoting 4/24/2024

   Bulk filling drug substances in traditional facilities is often a lengthy, manual process where operators are relied upon to adjust pump controls to achieve accurate filling. This method, spanning multiple shifts, increases process risk through errors that can compromise accuracy.

9. 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.

10. 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.