Hallmarks of Polymersome Characterization

Polymersomes have the potential to become the next generation of vesicular drug delivery systems. Their high chemical versatility and in certain cases higher membrane stability than liposomes raised the high hopes for polymersomes as a drug carrier, but the clinical translation has been slow. To jump-start translation, there is a need for meticulous characterization and reporting of key parameters of polymersome formulations. Regulatory authorities have provided valuable insights on critical quality attributes of liposomes in their guidance document on liposomal nanosimilars. Inspired by this guidance document, this Perspective proposes necessary characterization of polymersomes (hallmarks) regarding their chemical composition, physicochemical properties, drug release profile, stability, stimuli responsiveness, and pharmacokinetics and biodistribution.