Biosimilar App Notes & Case Studies

1. How To Protect A Modern Silicone Oil-Sensitive Biologic Drug For Self-Injection Of 2.25mL 4/25/2023

   A customer experienced expensive project delays when they selected their “tried and tested” large volume, glass syringe system to package a drug to be used in an auto-injector for self-administration.

2. AAV Production In Suspension HEK293 Cells With Single-Use Bioreactors 10/13/2022

   Explore how we expanded HEK293/HEK293T suspension cells from small cell culture (20 mL) in shake flasks up to a 10 L culture in a benchtop Xcellerex™ XDR-10 single-use bioreactor system.

3. Establishing A Robust Workflow To Identify High-Performing Clones 1/13/2023

   Cell line development is a complex, labor intensive, and multistep process. Learn about a platform and host cell line that minimize the risk and timeline to develop high-performing clones.

4. Tangential Flow Filtration System Coupling To Enhance Solution Offerings 3/1/2023

   Discover a simple, easy, and versatile method for capsule and depth filtration of small volumes that moves research from cell harvest to purification as quickly and efficiently as possible.

5. AAV Process Intensification Using High Salt Lysis And Salt Tolerant Endonuclease 3/25/2024

   In the production of adeno-associated virus (AAV) vectors, cell lysis involves challenges addressed through high salt concentrations and a salt-tolerant endonuclease, enhancing titer and infectivity.

6. 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.

7. Bulk Filling Of Drug Substance | Accurate Aliquoting 4/24/2024

   Bulk filling drug substances in traditional facilities is often a lengthy, manual process where operators are relied upon to adjust pump controls to achieve accurate filling. This method, spanning multiple shifts, increases process risk through errors that can compromise accuracy.

8. Overcoming The Solubility Challenges Of Antibody-Drug Conjugates 6/3/2024

   Discover a chito-oligosaccharide that significantly improves the solubility of antibody-drug conjugates (ADCs) when included in the linker-payload construct.

9. Trends In Next-Generation Delivery Technologies 11/22/2023

   Learn how lipid nanoparticles are enabling a new generation of engineered cell therapies with a push toward more complex cell engineering and gene editing for allogeneic therapies.

10. Implementation Of Raman Spectroscopy For In-Line Monitoring 11/3/2022

    Explore the development and implementation of Raman spectroscopy-based soft sensors for process monitoring of CPPs in bench scale, CHO cell, intensified seed trains (N-1).