Biosimilar App Notes & Case Studies

1. 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.

2. Accelerating Bulk Harvest Release Testing With A PCR-Based Solution 7/3/2024

   Adventitious agent testing is frequently a bottleneck in downstream processing. Discover a PCR-based solution for manufacturing processes using CHO cells and animal origin-free components.

3. Lentiviral Vector Production Using Single-Use Bioreactors 5/6/2024

   Here, we outline a scalable and robust upstream process developed for LVV production of HEK293T cells and demonstrate how to expand HEK293T suspension cells.

4. Determining The Power Numbers For A Single-Use Mixing System 6/19/2024

   In designing a mixing process for scale-up, the power number is a critical parameter. Explore the determined power numbers for a single-use mixer at various mixing speeds and fill levels.

5. Cell Culture Media Mixing In A Benchtop Single-Use Mixer 11/13/2025

   Explore how efficient powder-liquid mixing and sterile filtration preserve media integrity and support reproducibility in biopharmaceutical workflows, with promising scalability for larger-volume applications.

6. Optimization And Scale-Up Of A Plasmid DNA Production Process 9/30/2025

   Optimizing pDNA production in E. coli requires strategic media selection and scale-up planning. Explore a study that identifies ideal conditions for high-yield manufacturing.

7. 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.

8. Simplifying CHO Cell Line Genetic Stability Testing 4/11/2024

   Here, we describe the use of whole genome sequencing to perform a comprehensive assessment of genetic stability in clonally derived CHO cell banks using the Aptegra™ CHO genetic stability assay.

9. Benchmarking Filtration Performance Of TFF Cassettes 5/30/2025

   Optimize your protein purification workflow with tangential flow filtration by comparing membrane performance and exploring how protein concentration impacts flux and MWCO selection in lab-scale systems.

10. Cell Retention Technology And Specialized Cell Culture Media 8/11/2025

    Explore how perfusion technology is transforming upstream bioprocessing by boosting productivity, reducing costs, and enabling process intensification while overcoming cell retention challenges.