Robustness Evaluation of a Legacy N-Glycan Profiling Method for a Therapeutic Antibody Under ICH Q14 Lifecycle Principles
These results underscore the importance of risk control, continual improvement, and lifecycle management to ensure reliable glycosylation analysis and the sustained robustness of legacy methods.
Authors
- Margaret A. Velardo
- Jingming Zhang (ORCID: https://orcid.org/0000-0002-0961-934X)
- Babita Saxena Parekh
- Chao Li (ORCID: https://orcid.org/0000-0001-5723-1414)
- Ming-Ching Hsieh
Institutions
- Eli Lilly (United States) (US)
Publication Details
- Journal
- Antibodies
- Published
- 2026-01-15
- DOI
- https://doi.org/10.3390/antib15010009
- Primary Topic
- Monoclonal and Polyclonal Antibodies Research
- Type
- article
- Field-Weighted Citation Impact
- 0.00