Process Characterization and Validation

Category: CMC Development and Manufacturing Consulting
On recommendation, Cilatus was asked by a Chinese biopharmaceutical company to support their process characterization and validation effort. Cilatus analyzed all development work done to date, carried out a comparability assessment to the reference medicinal product, and then developed a customized, multi-layer process characterization and validation framework and work plan for the client. The assignment started with a training effort on the regulatory requirements of the FDA and the European Union for key employees of the client company in China. Then Cilatus worked with the client on establishing standard operating procedures for process characterization and validation in order to anchor this work in the client Quality Management System. Next, multiple, risk-based assessments were carried out under Cilatus’ leadership with the client. The results of these assessments provided input to further development and operational work. Work with the client is still ongoing and references for this work and case study are available on request.