This dropped the SP from .040 to .024 from which it has never recovered.
The product yield from the fermentation process for PAT-DX1 was consistent with the small scale pilot
production run conducted previously. However the purification of PAT-DX1 from the cell harvest
resulted in lower drug product recoveries than expected. In view of this, Patrys is currently working
with its Contract Development Manufacturing Organisation (CDMO) to implement improvements for
the large-scale purification process. It is anticipated that a further engineering run for PAT-DX1 using
an improved large-scale purification process will commence in Q2, 2022.
Why not a similar reaction, a reversal, for this?:-
Melbourne, Australia; 30 August 2022: Patrys Limited (ASX: PAB, “Patrys” or the “Company”), a
therapeutic antibody development company, is pleased to announce its Contract Development
Manufacturing Organization (CDMO) has successfully completed specification testing of PAT-DX1 drug
substance produced in the recently-completed engineering run. As anticipated, the GMP material
produced has passed all specification requirements and can now be used to complete remaining preclinical toxicology studies in preparation for a phase 1 clinical trial of PAT-DX1 that is planned to
commence in H2 CY2023.
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