Scaling Up and Manufacturing
Core Leader: Dr. Tim Coleman
Nemucore Medical Innovations (NMI) is establishing a first in the nation cGLP nanomedicine manufacturing facility compliant with Quality by Design (QbD) principles. NMI activities 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.
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.
NMI’s plan is use the core funding develop a QbD environment which cans 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 of the consortiums nanomedicines.
1. Develop process design space based on targeted product profile (TTP) and critical quality attributes (CQA) for consortium nanomedicines
- Develop the target product profile and critical quality attributes for consortium nanomedicines;
- Develop functional processes parameters for the nanofabrication consortium nanomedicines.
2. Investigate the impact of key input variable and process parameters to define process control specifications:
Transform lab scale synthesis into a suitable process to achieve cGLP scale with appropriate TPP and CQA.
To overcome this nationwide bottleneck, NMI is converting a GMP site and is establishing a GLP nanomedicine manufacturing facility in the Boston/Worcester life science corridor, a “hub” for preclinical nanomedicine development. NMI’s facility will prove invaluable to local industry as access to GLP material should stimulate service contracts to develop novel DMPK, biodistribution, and other in vivo studies to articulate how nanomedicines should be administered clinically. NMI’s facility will be a first in class pilot scale GLP facility dedicated to the production of complex nanomedicines for use in pre-clinical, Phase 0, and Phase 1 product development.
Research data and other relevant reporting will be shared according to the most recent NIH or other relevant guidelines while protecting patentable and other proprietary data and those restrictions on data sharing may be imposed by agreements with third parties. All required NIH and NCI reporting requirements will be specifically met by the team leads.