Biosimilar App Notes & Case Studies

1. Determining RNA Integrity And Purity By Capillary Gel Electrophoresis 6/30/2023

   To ensure mRNA product quality, it's important to confirm the integrity of the RNA. Examine the results of a study challenging the performance of the CGE method in assessing mRNA integrity and purity.

2. 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.

3. 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.

4. Get Full Control Of Your T Cell Isolation 3/25/2024

   This study demonstrates the automated magnetic isolation of CD4/CD8+ cells from fresh or frozen leukapheresis using a functionally closed cell processing system paired with a modular application.

5. Using Automated Spinoculation For CAR T Cell Lentiviral Transduction 2/26/2024

   There is a growing demand for closed and automated lentiviral transduction steps in CAR T cell therapy workflows. Learn about a potential solution to address this unmet need.

6. 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.

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. 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.

9. Monitoring Bioprocesses In A Light Environment Using Raman Spectroscopy 6/14/2024

   Discover an advanced solution to facilitate the implementation of Raman technology at both laboratory and manufacturing scales in a normal light environment.

10. Fab Fragment Development And Manufacturing For Clinical Trials 6/12/2024

    Explore the outcomes of implementing an accelerated approach to process development and manufacturing for a project that was crucial for the future of Acticor Biotech and its therapeutic candidate.