Nanofabrication Core Facility Nemucore Medical Innovations (NMI) is establishing a first in the nation cGLP nanomedicine manufacturing facility compliant with Quality by Design (QbD) principles. NMI activities will focus on converting consortium nanomedicines into target product profiles and defining the critical quality attributes required to manufacture material at a GLP scale. Our efforts will prove the NMI facility can become a national resource to advance the promise of nanomedicine. Fundamentally, NMI will be creating an environment where lab scale fabrication and chemistry will be engineered into repeatable, in control processes: a capability completely absent today. QbD allows a common manufacturing footprint to become a highly flexible process driven environment that is capable of handling multiple product pathways. This concept of flexibility is important as nanomedicines have taken on many different physical properties but they do have similarities in how they are assembled and prepared for investigational purposes. Additionally, the QdD model is also adaptable to multifunctional nanomedicines, with potential to target, image, and deliver therapeutic payload from a single platform. NMI's plan is use the core funding develop a QbD environment which can manufacturer multifunctional: liposomes, polymeric nanoparticles, liposomes, polymeric micelles, polymeric nanoparticles, and dendrimers. NMI's activities indicate how NMI will commission, calibrate, qualify, and validate a flexible manufacturing environment for the pilot scale GLP production ofthe consortiums nanomedicines.
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