CNS Pharmaceuticals, a biotechnology company specializing in the development of novel treatments for brain tumors, said that Anthem Biosciences of Bangalore, India has completed a pilot run of the recrystallization of the Reata Pharmaceuticals’ active pharmaceutical ingredient (API). It has also completed a lyophilization of the API. Samples of the drug product, which include 299 capped vials, have been shipped to Intertek Pharmaceutical Services for further analysis and release.
 
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 lyophilized form of the drug product could be used during the company's upcoming clinical trial.
 
Anthem, a full-service provider of GMP manufacturing for APIs, completed this pilot run of the Reata API. The pilot run recrystallization passed all specifications at Intertek. The recrystallized API was shipped to Lyophilization Technology, Inc. a provider of GMP lyophilization of drug products for clinical trials, which completed a pilot lyophilization. The pilot run of lyophilized API was successfully tested and released by Intertek.
 
"We are excited to achieve another important milestone in the development of Berubicin," said John Climaco, chief executive officer, CNS Pharmaceuticals. "We look forward to completing both GMP manufacturing processes and release for clinical trials."