Senior Principal Scientist Pfizer Inc. Chesterfield, Missouri
Based on QbD principles, prior knowledge of the critical quality attributes and its potential impact on the safety and efficacy are strongly desired for monoclonal antibody development. Backbone and methyl group based 2D NMR fingerprinting is a robust tool to monitor higher order structural (HOS) changes at a residue level during various stages of product development. Multiple attributes of mAbs can be monitored using a single NMR spectra acquired under nondenaturing and close to formulation conditions. In addition to the stress-induced impact on the global HOS, localized HOS changes spanning few residues that may be involved in functionally relevant protein-protein interactions can be monitored using NMR. A case study on the applications of NMR as a heightened characterization tool for bridging structure-function will be discussed.
Applications of new approaches in HOS characterization (eg. NMR)
Participants will be able to learn about the right usage of higher order structure (HOS)
characterization in product development
Upon completion, the participants will know the sensitivity and resolution of the wide range of
orthogonal tools available at their disposal for critical quality attribute assessment, comparability, characterization and
manufacturing investigation purposes.