NanGenex Inc. has successfully completed the chemical validation of its latest GMP compliant pilot plant reactor.
This is the first milestone towards fulfilling production needs of the clinical development of NanGenex's NanoActive™ products.
The chemical validation was carried out with active components of two blockbuster drugs. Nanoparticles of cGMP-specific phosphodiesterase type 5 inhibitor and an angiotensin II receptor antagonist drugs were generated with previously set parameters (flow rates, pH, temperature, concentration). These two NanoActive™ Drugs are being commercialized by NanoForm Therapeutics Ltd, London, UK.
During a daily shift the NanoPilot™ reactor can produce 2-4 kilograms actives. Series of tests confirmed that due to the breakthrough design of the equipment, reproducibility is guaranteed and the generated nanoparticles have constant quality. Moreover, the benefits experienced during the production of NanoActives™with the benchtop instruments are also achieved. The nanoparticles from the pilot instrument also demonstrated increased dissolution rate, solubility and bioavailability.
"The importance of this milestone is that we not only created an innovative tool for laboratory use but also established a new industrial scale technology"- said Gabor Heltovics, CEO of NanGenex.
NanGenex is going to present its latest results at the upcoming World Drug Delivery and Formulation 2011 meeting, 17th - 18th January 2011 in Germany.