Proteoform specific process validation
Patent Information
- Application Number
- GB2023003660
- Authority / Receiving Office
- GB · GB
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2020-09-16
- Filing Date
- 2021-09-16
- Publication Date
- 2025-03-26
- Estimated Expiration
- 2041-09-16
AI Technical Summary
Existing methods for monitoring proteoform biosynthesis and quality attributes (CQAs) in cell extracts and body fluids are inadequate due to the dynamic and complex nature of proteoform formation, influenced by environmental variables and lack of tight regulatory control, which complicates process validation and diagnostic accuracy.
A continuous process validation system (CPV) with a dual-sector instrument platform for top-down and bottom-up analyses, utilizing multi-modal analytical strategies and artificial intelligence to monitor and confirm proteoform/CQA ratios, incorporating chromatographic and electrophoretic separations, and mass spectrometry for precise identification and quantification.
Enables rapid, continuous, and automated validation of proteoform production processes, ensuring process continuity and product quality by detecting deviations and confirming proteoform identities and concentrations, even in the presence of host-cell proteins and metabolites, with high sensitivity and specificity.