Posted: 1 August 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) advised the Company that it has identified an inconsistency with one of the processes used in specification testing which is currently being rectified. In view of this, the CDMO has 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 second half of August 2024. This specification testing must be successfully completed for the drug material to be released for use in clinical trials.
As has been previously noted, the availability of GMP drug material is on the critical path for initiating the clinical development process, and delays with specification testing and drug release directly impact on the commencement of clinical development activities for PAT-DX1. While frustrated by this additional delay, Patrys’ current understandings is that specification testing will be completed in the next 4 weeks. The COmpany will advise if there are any further amendments or developments in relation to this revised timeline.
