Protein Dynamic Solutions Inc.

ProteinMentor® is PDS' flagship platform, a high-throughput analytical technology that provides biopharmaceutical companies unprecedented knowledge of critical quality attributes for biologics. It provides powerful insights for candidate selection and re-engineering and drives corporate value through faster approval of more pipeline candidates. Developability: Aggregation in protein therapeutics manifests in product efficacy, immunogenicity and anti-drug antibody risks, contributing to biopharma pipeline failures and resulting in significant cost burden. Unlike existing analytical and formulation technology processes, our patented method provides detailed molecular behavior of the protein therapeutic, for first time providing domain stability and the mechanism and extent of aggregation. ProteinMentor provides high throughput (over 200x faster than existing competitors) developability assessments in the presence of various excipients under different stressor conditions. The label free analysis can be carried out in solution at any drug concentration, regardless of its stage in the pipeline. Comparability: ProteinMentor is valuable for evaluating batch-to-batch comparability during process, site or manufacturing changes. Equivalence testing of biosimilars with innovator products in real-time under the same stressor conditions provides statistically robust data to establish analytical biosimilarity. The platform can be used by biosimilar manufacturers to demonstrate similarity or by innovator organizations to provide valuable added patent protection.