Brexpiprazole - Another Successful Project in API R&D
Thanks to the active engagement of specialists from Process Development Laboratory, Analytical Development Laboratory and other members of the Team, next project has been completed successfully. This time manufacturing technology of the active substance – Brexpiprazole has been developed.
What is the most important project was completed within strict timelines, fulfilling the needs of the most demanding markets in this field like USA. Additionally, the application of innovative filtration technologies, along with the expertise in Impurity Control Strategy (including genotoxic impurities) has led to the development of robust manufacturing of active substance complying with all quality requirements.
Manufacturing technology of Brexpiprazol has been transferred from API Plant R&D laboratories to Pilot Plant facility in July 2017. In January 2018, positive results of stability tests after 6 months has been recorded (six month study in accelerated conditions has been completed). Meanwhile, EU ASMF and US DMF have been prepared. Moreover production process was given positive recommendation for GMP certification by Chief Pharmaceutical Inspectorate.
Brexpiprazole was developed and marketed by Otsuka and Lundbeck and it is an atypical antipsychotic. In July 2015 FDA granted approval for the registration of Brexpiprazole in the treatment of schizophrenia and as adjunctive treatment of major depressive disorder.
Author: Mateusz Godzisz, Project Management Team Manager | API Plant R&D Division