From an industry perspective, a potential bottleneck that will need to be overcome in bringing targeted nanoparticles from the bench to the bedside is scale-up. Existing academic laboratory environments are adequate for manufacturing enough targeted nanoparticles for ongoing preclinical studies (in vitro and in vivo). However, human studies and clinical use will require far greater quantity of targeted nanoparticles and will require GMP-compliant facilities. Contract Manufacturing Organizations (CMOs) typically fill the role of manufacturing drugs for biopharma companies. There are very few, if any, CMOs that have the capability to manufacture targeted nanoparticles. Anticipating this potential bottleneck, it would behoove NCI to support efforts in developing robust, reproducible methods to manufacture targeted nanoparticles. Such efforts would include: scale-able conjugation methods, reproducible nanoparticle formation, and universal quality control and assurance methods.
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