Biosimilar App Notes & Case Studies

  1. Don't Intensify Blindly: Preventing Fouling And Restoring Performance With Targeted Cleaning Of Protein A Resins 8/27/2026

    Protein A chromatography intensification can increase productivity, but it may also affect process robustness. Explore key tradeoffs, operational challenges, and practical considerations.

  2. 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.

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    Upgrading outdated filling systems is essential for meeting future production demands and regulatory standards.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

  4. Automation And Digital Solutions Can Help You Reach Your mRNA Manufacturing And Sustainability Goals 1/14/2025

    Explore how digital solutions help streamline mRNA manufacturing by reducing costs, improving efficiency, and supporting sustainability by creating paperless processes for emerging therapeutics.

  5. 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.

  6. Microbial Integrity Of Sampling Systems After Multiple Actuations 4/6/2026

    Repeated sampling doesn’t have to mean increased contamination risk. See how microbial ingress testing demonstrates sterility integrity after up to 50 sampling actuations.

  7. CDMO Uses Robotic Gloveless Isolator For Advanced Therapeutics 4/28/2025

    CDMOs must innovate production architectures to meet the demands of advanced therapeutics to ensure a reliable supply and compliance. Discover how these approaches advance modern medicine and improve patient outcomes.

  8. Controlling mAb Aggregates In Chromatography Process Development 5/22/2026

    Antibody aggregation remains a critical downstream challenge, particularly for complex modalities. Explore why aggregates form, why they matter, and how chromatographic strategies can help reduce risk.

  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. 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.