Protein Dynamic Solutions Inc

ProteinMentor® is PDS' flagship platform, a high-throughput analytical technology that provides biopharmaceutical companies assessment of multiple critical quality attributes for biologics. It delivers powerful insights for pre-clinical candidate selection and acceleration of speed to market to drive corporate value. Developability and End-to-end Comparability Assessment: A true multi-attribute evaluation of a multiplex of intact therapeutic proteins in their formulation. Among the CQAs assessed to date: protein Id and product related impurities, self-association, aggregation, Asn / Gln deamidation, extent of glycosylation, stability and epitope mapping. ProteinMentor is especially suited for the implementation of ICH Q5E guidelines by providing accurate, reproducible and statistically robust results to evaluate the adverse impact on product quality due to a process control change and batch-to-batch evaluations to ensure product quality, safety and efficacy throughout manufacturing process including release testing. Also, the platform is valid for testing at high concentration / high dosing conditions. ProteinMentor is comprised of 3 main components:(1) a quantum cascade laser microscope,(2) innovative slide cell array that provides flexibility in the design of experiment under accurate thermal control and (3) a portfolio of software suites powered by two-dimensional correlation algorithms providing unprescedented understanding of the therapeutic proteins analyzed. A series of real-time hyperspectral (HS) images are acquired at the desired set temperature. Each HS image is comprised of high quality spectra that is highly sensitive and selective ideal for deep machine learning enabling predictive results. Finally, this platform technology is cloud ready and 21 CFR 11 Part compliant through a centralized data management system to ensure data integrity. A solution that addresses the complexities of therapeutcs for the biopharma industry.