Clinical-stage biotechnology company PharmAust (ASX: PAA) has reported positive results from ongoing product stability and shelf-life testing of its lead anti-cancer drug candidate monepantel in tablet form.
Data from two independent studies have shown the tablets will remain “well within limitations and specifications”, even when temperature conditions rise to as high as 25 degrees Celsius and 60% humidity.
The Good Manufacturing Practice (GMP) grade stability studies were conducted by two GMP programs and featured storage periods of up to 24 months each.
GMP is a globally-recognised standard which requires rigorous, controlled and documented processes to provide fully-characterised drugs with the highest levels of purity for safe and effective administration to patients.
GMP meets the standards required for clinical trials in Australia, the United States and Europe.
PharmAust chief scientific officer Dr Richard Mollard was pleased with the latest stability achievements in the development of monepantel.
“The stability data for the tablets currently being used for veterinary work provides us with great confidence that the next round of GMP tablets made for human testing will similarly meet required specification levels,” he said.
“Having a robust GMP tablet significantly reduces the costs associated with repeat manufacturing programs and provides certainty for our clinical trial scheduling.”
Stability and shelf life
Biopharmaceutical products in storage change as they age but are considered to be stable as long as their characteristics remain within a manufacturer’s specifications.
The number of days a product remains stable at the recommended storage conditions is referred to as its shelf life.
Stability testing is a routine procedure employed at various stages of a product’s development.
In the early stages, accelerated stability testing at relatively high temperatures and humidity levels is used to determine the type of degradation which may be encountered after long- term storage.
Testing under less rigorous conditions is used to determine a product’s shelf life and expiration dates.
Acceptable level of quality
The aim of stability testing is to provide developers such as PharmAust with reasonable assurance that their drug will remain at an acceptable level of quality from point of supply to the market through to a patient using the last unit of a product.
Dr Mollard said product stability and shelf life would continue to be important criteria as PharmAust moves towards a phase three monepantel trial and identifies potential commercial partners.