Affiliation:
1. Johannes Gutenberg-University Mainz, Germany
2. EMBL
3. University of Mainz
4. BioNTech SE
5. Postnova GmbH
Abstract
Abstract
We present a generically applicable approach to determine an extensive set of size-dependent critical quality attributes inside nanoparticulate pharmaceutical products. By coupling asymmetrical-flow field-flow fractionation (AF4) measurements directly in-line with solution small angle X-ray scattering (SAXS), vital information such as (i) quantitative, absolute size distribution profiles, (ii) drug loading, (iii) size-dependent internal structures, and (iv) quantitative information on free drug is obtained. Here the validity of the method was demonstrated by characterizing complex mRNA-based lipid nanoparticle products. The approach is particularly applicable to particles in the size range of 100 nm and below, which is highly relevant for pharmaceutical products – both biologics and nanoparticles. The method can be applied as well in other fields, including structural biology and environmental sciences.
Publisher
Research Square Platform LLC