US-based biotech has completed pilot manufacturing steps persuant to FDA pre-IND guidance for production of API for new clinical trial
Image as seen on CNS company video depicting the ability of Berubicin to cross the blood-brain barrier
CNS Pharmaceuticals, a biotechnology company specialising in the development of novel treatments for brain tumors, has completed the final GMP manufacturing run of its lead candidate Berubicin, which it acquired from Reata Pharmaceuticals, and that the GMP material has met all specifications.
Samples of the lyophilised drug product were shipped to Intertek Pharmaceutical Services for final GMP testing.
The pilot recrystallisation run met all specifications and the initial GMP run passed all specifications; however, it was discovered that one of the standard 10 metals in Heavy Metals Test, bismuth, was not officially validated for that assay. This did not prevent the formulation of the final drug product. Subsequently, heavy metals including bismuth were again tested and met all specifications.
Additionally, CNS is continuing large scale production of Berubicin through NCK. NCK is a GMP manufacturer of complex drugs located in Farum, Denmark, and the previous producer of Berubicin for Reata Pharmaceuticals.
CNS intends to utilise this supply of Berubicin for its potential upcoming Phase II clinical trial in Glioblastoma. As previously announced, the FDA agreed in a preclinical submission that CNS could use Reata API as long as it was reprocessed and released under GMP conditions, and that the new lyophilised form of the drug product could be used during the CNS’ upcoming clinical trial.
"Completing GMP Manufacturing represents another pivotal step in our Berubicin production," said John Climaco, CEO of CNS Pharmaceuticals. "We are excited to continue our productive start to 2020 by completing another manufacturing milestone and look forward to further advancing both the production and clinical development of our lead candidate. We hope to continue our manufacturing success and utilise our supply of Berubicin for upcoming clinical trials and commercial use."