PDS technology allows biopharmaceutical companies to simultaneously evaluate seven critical quality attributes (CQAs), essential to optimized drug candidate selection and formulation.
The PDS platform is a unique combination of microscopy and spectroscopy, allowing the direct visualization of aggregates and a determination of the exact regions, amino acids and mechanisms of aggregation.
An enhanced understanding of the molecular mechanisms and location enables improved drug candidate selection, optimized biopharmaceutical formulation and logic-guided re-engineering where necessary. The additional level of molecular characterization can afford innovator organizations an added level of valuable patent protection.
Equivalence testing of biosimilars with innovator products in real-time under the same stressor conditions provides statistically robust data to establish analytical biosimilarity.
PDS provides a unique and higher-order structure characterization of drug molecules and provides crucial molecular dynamic information for in silico simulations and protein design.
The platform can be used by biosimilar manufacturers to demonstrate similarity and by all manufacturers to evaluate batch-to-batch comparability during process-, site- or manufacturing changes.
PDS determination of Higher Order Structure provides conclusive identification of counterfeit versus authentic protein therapeutics.