The Nanotechnology Characterization Laboratory (NCL) is a national laboratory in Frederick, Maryland, that was founded in 2004 in collaboration with NCI, FDA and NIST to provide preclinical characterization of cancer nanomedicines to support their clinical translation. The NCL has a world class multi-disciplinary staff of scientists with expertise in chemistry, pharmacology, toxicology, cancer biology, immunology, and formulation science. Since its founding, the NCL has characterized over 400 nanoparticles of all different types, collaborated with more than 100 universities and companies worldwide, and helped advance more than a dozen products into/through clinical trials.
Admission into the NCL program is very rigorous, and 40% of submissions fail at one of the first steps in the extensive NCL Assay Cascade: endotoxin testing. Siva entered to program in 2016 as manufacturing of SivaRods was initially being scaled. We completed the program, with excellent results for successive manufacturing batches of SivaRods, in 2019. The program included a broad range of tests and characterizations of SivaRods, as well as panels of animal studies. A brief summary of results is provided here; the full report can be made available to interested parties.
SivaRods for injection have achieved the following manufacturing and safety milestones:
- 10-liter batches (originally 50 microliters
- >85% of SivaRods are the target size and aspect ratio
- No detectable in vitro cytotoxicity, hematology, or immunology issues
- Sterile, no chemical contaminants, endotoxin below allowable limit
- Excreted in both urine and feces
- Quality exceeds specifications
- Full GMP production next