Regulatory agencies require rigorous analysis of critical quality attributes (CQA’s) be executed throughout development and production of therapeutic proteins to ensure efficacy and safety. Such attributes include determination of higher order structure, stability under agitation and thermal stress, and aggregates.
Three case studies will demonstrate the unique capability of the ProteinMentor™ platform to deliver all of the above across an array of samples, as well as to provide real-time, label-free visualization of aggregates and the determination of domain stability as they occur in undiluted, injectable drug formulations and earlier-stage, low concentration samples alike.
• For the first time we will directly compare an array of homologs and biosimilars of injectable insulin as a model for studying subtle differences in sequence and their structural implications under thermal stress and how protein engineering has been used effectively to impart differing pharmacokinetic properties
• Steps in the purification workflow of a biosimilar will be assessed for risk of imparting deleterious effects on the candidate protein. This is achieved via comparison of the protein before and after discrete workflow phases. Of particular interest, ProteinMentor allows assessment of such steps as low-pH viral clearance; identifying exact amino acid/s impacted by events such as deamidation and/or truncation
• Colloidal stability of therapeutic monoclonal antibody drug candidates will be compared side by side, under two different formulation conditions and varying protein concentrations
Belinda Pastrana, Ph.D.
CEO and Founder
Protein Dynamic Solutions
Thirty years developing cutting-edge solutions for protein characterization, with 20 years in pharmaceutical bioprocessing. Patented innovator in protein aggregation & tenured faculty member at the University of Puerto Rico.
Cost: No Cost!