The NNPP manufacturing facility is housed within Nebraska Medicine’s Biologics Production Facility (BPF). Nebraska Medicine and the University of Nebraska Medical Center jointly operate the facility. Compliance with current good manufacturing practices (cGMP) provides environmental safeguards, quality management and security required for the manufacture of drugs.
The NNPP will operate out of a segregated suite for specialized clinical projects.
Unidirectional flow of personnel and product will reduce product contamination and facilitate compliance with FDA production guidelines. 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.