Posted: 4 September 2024
Patrys Limited a therapeutic antibody development company, provides the following update regarding the recently completed GMP manufacturing run of PAT-DX1.
Patrys’ Contract Development Manufacturing Organization (CDMO) has advised the Company that specification testing using a revised process is still not complete, and that the revised process is proceeding through Quality Assurance and Quality Control approvals. Accordingly, the Company that specification testing using a revised process is still not complete, and that the revised process is proceeding through Quality Assurance and Quality Control approvals. Accordingly, the Company has been advised that specification testing for the drug substance produced in the recent manufacturing run of PAT-DX1 is now expected to be complete in mid-September 2024.
As previously noted this specification testing must be successful completed for the drug material to be released for use in clinical trials, and delays with specification testing and drug release directly impact on the commencement of clinical development activities for PAT-DX1. The Company will advise if there are any further amendments of developments in relation to this revised timeline.
