Developing methods that are capable of analyzing multiple protein drug candidates across a drug development program is a cost- and time-efficient strategy. Development involves identifying constant and variable regions of the protein and selecting the identical sequence as signature. A platform method was recently developed for a drug development program of multiple bispecific therapeutics. Due to the tendency of the therapeutic forming protein-complexes, it was difficult to capture the molecule in monomer form. This was resolved by extensive dilution of the sample. In addition, the capture antibody had residual drug product making accurate quantitation challenging. This was overcome by titrating the capture antibody used to pulldown the drug. This method has been successfully validated for two candidates and implemented in the program for clinical PK studies. Method performance met acceptance. Our approach facilitated a universal method for this therapeutic class, greatly reducing the time and cost for the drug development.
Learning Objectives:
Upon completion, the participants will be able to identify the situation in which a platform method can be developed for a drug development program.
Upon completion, the participants will be able to create strategies for developing platform methods for protein drug candidates shares the same structural framework.
