Posted: 23 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 Organisation (CDMO) has advised the Company that the Quality Assurance and Quality Control approvals for the revised specification testing protocols are pending, and accordingly the final product testing is yet to be completed. 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 the first half of October 2024.
As previously noted this specification testing must be successfully 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 or developments in relation to this revised timeline.
