The NNPP GMP facility will be housed within UNMC's Lied Transplant Center.
The GMP cleanroom suite contains air quality up to class 100 air quality (ISO 5), a separate controlled entrance, and gowning and de-gowning space. It will have temperature-controlled reagent storage and facilitate compliance with FDA production guidelines.
To provide for a fluid transfer of the scaled-up GLP production processes to GMP production for pre-clinical safety and Phase 1 clinical studies, the facility will be fitted with GMP-validated equipment mirroring that in the pre-production facility.
This facility will provide an aseptic fill and finish (terminal sterilization will need to be done with an outside company), lyophilization with and FDA compliant Bench Mark 500 lyophilizer with steam and clean in place capability.
The manufacturing facility will operate out of a segregated suite for specialized clinical projects. The modular facility can adapt to the changing needs of different projects. It will also offer a wide array of assays such as endotoxin testing if deemed necessary for product characterization.
Renovation began in December 2017. Progress/completion forecast:
- 50% Progress Document Submittal 1/11/2018
- 99% Progress Document Submittal 2/8/2018
- Construction Document Submittal 2/22/2018
- Bid Date 3/22/2018
- Substantial Completion 7/12/2018
- Commissioning and Validation 8/23/2018
To provide a fluid transfer of the scaled-up pre-production processes to final production, the facility will be fitted with GMP-validated equipment mirroring that in the pre-production facility.
- chemical/fume hood
- rotavap with oil-free pump
- Benchmark 500 GMP lypophilzer
- Avestin Emusiflex C3 high pressure homogenizer
- Malvern Zetasizer NanoZS
- tangential flow filtration system
- MCTech membrane emulsifier
- Hielscher ultrasonicator
The NNPP manufacturing facility is currently undergoing major renovations for GMP production of nanomedicines.