API Development Case Study
CASE STUDY: API Development for US Biotech Client
Rapid development of a scalable route towards an analogue of a new drug substance, with definition of an optimal salt form for formulation
US Biotech client developing combined Small Molecule / Biologic immunotherapy treatments
ARCINOVA developed two process route options and selected one on the basis of scalability and process economy. The API free base was generated and a rapid salt screening protocol undertaken. A solubility study was undertaken which showed optimal solubilisation at a set pH. The client was delighted and has filed provisional IP. The drug substance analogue shows superior solubility to the prime API.