Biosimilar App Notes & Case Studies

1. 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.

2. Lentiviral Vector Upstream Process 12/12/2025

   Scalable lentiviral vector production is moving beyond adherent systems. Learn how streamlined workflows enable linear scale-up in stirred-tank bioreactors for cost-effective gene therapy manufacturing.

3. Virus Retention Performance Under Diverse Processing Conditions 11/14/2025

   Virus filtration is robust across a wide range of process parameters, including high protein concentration and flow decay. Discover how retention relies on size exclusion to simplify risk assessment.

4. Mild pH Protein A Purification Step With A Mild Elution Resin 5/22/2026

   As antibody formats diversify, low-pH protein A elution can drive aggregation and yield loss. Learn how milder elution conditions during capture can help protect sensitive molecules and ease challenges.

5. Protect Your Columns And Your Peaks 2/24/2026

   Learn how thoughtful filter selection can protect LC systems, improve protein recovery, and support reliable chromatographic results with key performance data and solvent compatibility insights.

6. 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.

7. Comparing Process Development Approaches For Recombinant Proteins 2/26/2026

   Explore how adding a traceless tag enables streamlined affinity purification for recombinant proteins, and how this approach compares with a conventional process in development time, recovery, and purity.

8. 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.

9. Media And Buffer Mixing Using The Xcellerex™ Magnetic Mixer 6/19/2024

   A common requirement for media and buffer preparation in biopharma processing is powder-liquid mixing. Review the performance of a 3000 L single-use mixing system for preparing aqueous solutions.

10. Production Of A Highly Concentrated Monoclonal Antibody 10/4/2024

    The production of a highly concentrated monoclonal antibody requires many process steps. Discover how to achieve a final mAb concentration above 200 g/L while maintaining critical quality attributes.