(567h) Augmenting Biologics with Cost-Effective Controlled Release Formulations

Rothstein, S. N., University of Pittsburgh, Qrono Inc.
Little, S. R., University of Pittsburgh, ChroKnow Solutions (r)

Controlled release technology can resolve the half-life and delivery issues that prevent regenerative medicines, vaccines and many other biologics from achieving their full potential. However, current methods for developing custom release formulations require costly trial-and-error experiments that rarely achieve optimal delivery kinetics. Recent advances in the design of such formulations have been spun into new company, ChroKnow(r) Solutions. Our non-iterative design methodology is the very first that can pre-program a wealth of delivery schedules into resorbable polymer matrices of any shape, size, and form. These matrices can also be made entirely of the ?FDA approved? materials poly(lactic) acid and poly(lactic-co-glycolic) acid without compromising their delivery kinetics. Further, because design is done in silico this approach is incredibly rapid. The result is that custom timed release formulations can now be cost effectively developed on a miligram to gram scale for use in preclinical testing and other small scale or early stage operations.

In early testing, formulations designed with our technology have resolved half-life and delivery issues in a variety of preclinical models. For example, our neonatal vaccination platform has successfully delayed the onset of immunization for seven days following injection. Comparably precise control is predicted for delivery schedules extending to one year. Another rationally designed vehicle has successfully extended the dosing interval for the antiviral peptide, enfuvirtide, from twice daily to once every 30 days. A third formulation provides local delivery of cytokines and chemokines in a regenerative treatment for periodontal disease. Similar advances can be made by augmenting other biologics with rationally designed formulations that localize application, automate dosing, and extend delivery.