Using good laboratory practice (GLP) guidelines, the NNPP pre-production facility will optimize the production, purification, lyophilization and characterization of selected nanoformulations for advancement to preclinical toxicology studies.
This facility, located in the Durham Research Center, began renovation in 2015 and is slated to open February 2016.
The function of the pre-production facility is to facilitate scale-up production and feasibility studies.
- chemical/fume hood
- rotovap with oil-free pump
- Lyostar-3 programmable lypophilizer
- Avestin Emulsiflex C3 high pressure homogenizer
- Malvern Zetasizer Nano ZS
- tangential flow filtration system
- MCTech membrane emulsifier
- Hielscher ultrasonicator
- Cole Parmer electric desiccator storage cabinet
These pieces of equipment afford great flexibility in the manufacture of most types of nanoformulations for drug delivery. The final formulation process and quality control validation developed in the pre-production facility will be transferred to the manufacturing facility for GMP production of nanomedicines for preclinical toxicology studies and Phase 1 clinical trials.
GLP production protocols will be developed using a quality by design approach in consultation with the NNPP Operations Manager and Quality Assurance Manager. This approach will ensure that scaled-up production and process validation methods will meet FDA requirements for GMP production and IND submission.