Biosimilar App Notes & Case Studies

1. Extractables In Single-Use Systems Used In ADC Manufacturing 9/23/2024

   To address concerns about using organic solvents in the ADC process, extractables studies were conducted on a disposable chromatography column housing and two different disposable flow paths.

2. A Transient Cell Line To Produce rAAV With Low-Level hcDNA Encapsidation 1/15/2025

   Discover the ability of a novel HEK293 suspension cell line for efficient and scalable rAAV production across various serotypes with low encapsidated host cell DNA levels.

3. Improving Bioprocess Monitoring And Control With Multivariate Data Analysis 12/9/2024

   Learn about multivariate data analysis (MVDA) techniques, like PCA and PLS, that enable near real-time monitoring, prediction, and optimization of biomanufacturing processes.

4. 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.

5. Packing MabSelect™ And MabSelect SuRe™ Resins Using Verified Methods 12/6/2024

   Proper packing of MabSelect resins is crucial for efficient chromatography. Verified methods ensure stability, optimal flow, and reproducibility across scales using automated tools.

6. Assessing Particle Generation In A Single-Use Mixing System 11/13/2025

   Explore how particle levels remained stable during 24 hours of high-speed mixing, even under extreme temperatures, confirming a system’s suitability for final fill and other particulate-sensitive applications.

7. Mobius® ADC Reactor Performance 10/22/2024

   Learn about a family of single-use ADC reactors that has been developed to offer a safer and more efficient ADC production method than traditional mixing systems and meet the industry's growing needs.

8. Adapting Single-Use Chromatography To Manufacturing Scale 5/16/2024

   Explore strategies for accommodating the ever-increasing upstream titers and volumes to prevent downstream purification from becoming a bottleneck.

9. How To Successfully Isolate Your T Cells 10/7/2024

   Explore the results of a study focusing on the early stages of the CAR T cell workflow, specifically the initial washing of leukapheresis followed by the isolation of T cells.

10. 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.