(260) Reproducible and scalable polymer nanoparticle manufacturing facilitates clinical translation
Introduction: Polymer nanoparticles (PNPs) are a promising delivery method for gene therapies. PNPs can overcome known concerns for AAVs and LNPs, such as cargo capacity limitations, adverse immune responses, cell-based manufacturing challenges, and high cost of scaled production [1]. Reproducibility is crucial to successful delivery vehicle discovery and enables increased production to support clinical translation. This work used a rapid, iterative PNP discovery platform to demonstrate progress toward reproducible and scalable PNP manufacturing intended to facilitate gene therapy clinical translation.
Learning Objectives:
Understand the importance of scalability on production yield.
Examine how polymer composition can impact manufacturing reproducibility.
Assess how an iterative PNP discovery platform facilitates clinical translation of gene therapies.
Nickolas Andrioff, BS – Biomedical Engineer II, Battelle Memorial Institute; Ashlee Colbert, PhD – Materials Scientist II, Battelle Memorial Institute; Dean Constantine, BS – Chemical Engineer I, Battelle Memorial Institute; Phil Denen, BS – Materials Scientist II, Battelle Memorial Institute; Sam Farrar, MS – Chemist 1, Battelle Memorial Institute; Miguel Pedrozo, MS – Materials Scientist I, Battelle Memorial Institute; Pong Thongsavanh, BS – Technician Specialist, Battelle Memorial Institute; Andrea McCue, PhD – Lead Biologist, Battelle Memorial Institute; Danielle Huk, PhD – Senior Biologist, Battelle Memorial Institute; Kenneth Sims, PhD – Senior Materials Scientist, Battelle Memorial Institute
