Jun 19, 2019 – NMR Topical Group Meeting

Fast 1D fingerprinting methods will give a quick answer if the biologic is similar to the reference material. To identify changes at the amino acid level, 2D NMR methods are required. An interlaboratory comparison coordinated by NIST (26 labs involved, different magnetic fields, worldwide) demonstrated both high precision and high reproducibility of the 2D methyl fingerprint NMR method. We will show recently developed and optimized acquisition techniques, including excipient signal removal. We will also introduce a newly developed software that allows an optimal workflow for batch to batch analysis of mAb samples. It provides a robust platform for the repeated application of established, tested and, recently developed data evaluation methods, namely: Profile1D (developed by Amgen) and, BiologicsHOS software (developed through the Bruker and Mestrelab strategic collaboration) which includes CCSD (Combined Chemical Shift Deviation), ECHOS (Easy Comparability of Higher Order Structure) and, PCA (Principal Component Analysis) using either the entire spectrum or peaks. We will demonstrate the workflow, and show pros and cons of the different methods.