- MS in QC - A single multi-attribute method for quality control and release testing of biologics

摘要

Fundamentals of the single multi-attribute method for release: 1. Automated quantification combining Orbitrap technology and dedicated software for QC application. 2. Flexibility: (1)Method allows constant input resulting from increased knowledge of the drug attributes during process development and better understanding of their criticality from clinical experience. 3. Science-based: (1) Critical quality attributes-centered information using most advanced technology should be welcomed by regulatory agencies. (2) Scientifically superior to current methods (CE-SDS, CEX). MS-methods needs science-based arguments on why we monitor these specific parameters. Reduces cost of quality 1. Reduced number of release tests; 2.Process development simplified & more efficient.