Race Oncology Ltd (ASX:RAC) is preparing for Good Laboratory Practice (GLP) toxicology studies after securing a Certificate of Testing (CoT) from contract development and manufacturing organisation Societal CDMO.
The CoT for RAC’s first engineering batch of its proprietary bisantrene formulation, RC220, confirms the drug meets manufacturing quality specifications and clears the way for toxicology and safety pharmacology studies.
Important milestone
“Bringing a new IV drug product like RC220 to the clinic is a complex undertaking that requires successful progress through multiple checkpoints.
“The recent data confirming that RC220 satisfied all manufacturing quality specifications when produced at scale for the first time represents an incredibly important milestone, as it strongly supports our ability to produce GMP material suitable for human clinical use.”
An engineering batch (EB; non-GMP) of more than 1,500 vials of RC220 was manufactured.
The company says confirming that RC220 can be manufactured to the specified quality standards provides very high confidence that the production of cGMP RC220 currently in progress at Ardena will be able to meet the stringent specifications necessary for use in human clinical trials.