NanGenex validates nano-producing pilot reactor
Milestone towards fulfilling needs of the clinical development of its NanoActive products
Budapest-based NanGenex has 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 its NanoActive products.
NanGenex has developed a continuous flow precipitation technology for the synthesis of nanoparticles. The API particles produced using this technology can show enhanced solubility.
The chemical validation of the latest reactor was carried out with active components of two blockbuster drugs. Nanoparticles of cGMP-specific phospho-diesterase type 5 inhibitor and angiotensin II receptor antagonist drugs were generated with previously set parameters (flow rates, pH, temperature and concentration).
These two NanoActive drugs are being commercialised by NanoForm Therapeutics, London, UK.
During a daily shift, the NanoPilot reactor can produce 2–4kg of actives. A series of tests confirmed that due to the design of the equipment, reproducibility is guaranteed and the generated nanoparticles have constant quality. 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.
