A Platform Approach to Manage Developability & Manufacturability Risks of Biologics Molecules
PEGS Europe, Lisbon, Portugal
November 11, 2019
Larger panels of molecules are being subjected to more intense characterization associated with developability assessments being performed earlier in the biologics R&D process, which creates a barrier to the already significant challenges of large-molecule characterization. The need to have well-defined, high quality products for development and CMC is vital. A solution that supports integrated developability studies is critical to ensure the technical success of the chosen lead molecule. We present a scalable, off-the-self enterprise workflow system that enables systematic developability and manufacturability assessments from the very early stage to the later stages of the biopharma R&D process. It uses both in silico methods and high throughput analytical confirmatory methods. Moreover, it enables clear diagnosis of developability issues using genealogy management. We present concrete use cases, not only for mAbs, but also for complex multi/bispecific formats, as well as engineered therapeutic cell lines (e.g., CAR-T cells). We start with a peptide mapping use case where we compile a large number of processed MS results (MW, PMF coverage, PTMs – e.g., deamidation, oxidation, glycosylation). We complement this by a second use case showing the N-linked glycan analytics results for various antibody candidates from stable cell lines in which automated workflows make it possible to interpret the data sooner. A third focus is on bispecific heterodimerization where we show automatic, accurate identification and reporting of MW and abundance of homodimeric and heterodimeric species. This integrated biopharma platform forms a solid basis for building predictive models for developability.