Quick Turnaround for Challenging Projects

A sponsor needed release testing of process validation lots by assay and dissolution for three batches of drug product, with a 21-hour turnaround time for a QA-reviewed final report. The manufacturing site providing the sample to PPD had experienced technical difficulties transferring the assay method, allowing only two days notice to our lab. 

Three PPD analysts and a QA auditor spent the entire day and evening in the laboratory to complete the testing and reporting, and the client’s timeline was met with quality results, enabling the sponsor to initiate the Phase II clinical study as originally planned.