Development of Gene-Encoded Monoclonal Antibody Potency Assay

The objective of this proposal is to demonstrate the feasibility of a generalized, high throughput assay platform to characterize the functional performance nucleic acid-encoded monoclonal antibody therapeutics. The assay platform will utilize Printed Droplet Microfluidics (PDM), a new type of microfluidics that enables the construction of tens of thousands of nanoliter-scale experiments with complete deterministic control. The platform will perform workflows where unique combinations of transfected single cells, virus particles, and target cells will be combined at each position in a static array. At each array position, nucleic acid transfection efficiency, mAb production, and target cell health will be assessed. The resulting multi-parameter data will provide a comprehensive functional fingerprint for each production batch of nucleic acid-encoded therapeutic, and will be well suited to assess product variability.