Strategies to address the unexpected in cell line development
Accelerate characterization of post translational modifications that impact product quality
Characterization of post-translational modifications (PTMs) throughout the drug development is important to maintain product quality and efficacy. The charge heterogeneity profile can be directly impacted by PTMs like deamidation and oxidation during development steps such as the process intensification.
Through a series of webinars and interviews, learn how a cell line engineering and development team at Johnson & Johnson Innovative Medicine utilizes icIEF-UV/MS as a rapid multi-attribute method to monitor and characterize product quality attributes (PQAs) during process development.
- Guide decisions during cell line development with charge variant identification at the intact level
- Learn about the link between AGE formation and color change in final drug products as well as how to develop assays for rapid monitoring and tracking of these PTMs
- Reduce risk in monoclonal antibody (mAb) development with the Intabio ZT system
- Streamline PQA identification and peak integration with an EAD-based MAM workflow