Biotechnology company Argenica Therapeutics Limited (ASX: AGN) has successfully scaled up manufacture of its ARG-007 development to Good Manufacturing Practice (GMP) guidelines through its manufacturing partner in Australia.
Argenica is developing novel therapeutics to reduce brain tissue death after stroke.
GMP is a globally-recognised standard for ensuring rigorous and continually monitored processes in drug manufacturing to minimise risks and ensure drugs are safe and effective when administered to patients.
These strict regulatory guidelines also meet the standards required for clinical trials in Australia, the U.S. and Europe.
Argenica’s Australian based peptide manufacturer, AusPep, has tested all aspects of ARG-007 production and have confirmed the successful process development and scale up of GMP grade ARG-007.
Achieving GMP manufacturing of ARG-007 was essential for Argenica to undertake safety and toxicology studies in pre-clinical experiments before commencing its inhuman Phase 1 clinical trials.
The scaled-up manufacturing process by AusPep resulted in a final product with a purity of 99.9%. This is an important milestone, as peptide purity can have a fundamental impact on the drug’s safety, as the quality of a peptide drug will be impacted by its impurity profile.
Impurities in a peptide drug may change the desired efficacy of that drug, or induce unwanted toxicity.
For a drug to be used in clinical trials, a peptide drug must achieve a purity level of greater than 98%.
To mitigate manufacturing production risks associated with a single manufacturing partner, the company separately engaged a US based GMP peptide manufacturer, AmbioPharm, who also achieved process development optimisation of the manufacturing of ARG-007 at a purity of 99.3%.
Argenica’s CEO, Dr Liz Dallimore, said reaching these purity levels indicates AmbioPharm should be able to produce GMP ARG-007. Both these milestones allow the Company to progress towards clinical trials with increased confidence surrounding manufacturing and safety.
The GMP grade material is now with the company’s Clinical Research Organisation partner for use in pre-clinical studies required before conducing its Phase 1 clinical trials, including the standard genotoxicology, final pharmacokinetics, safety, and toxicology studies.
Passing the GMP scale up manufacturing milestone and process optimisation is incredibly exciting for Argenica, especially at the very high peptide purities generated,” Dr Dallimore said.
“We have de-risked our reliance on a sole manufacturing partner and achieved high purity product from both manufacturers. We now have a high purity GMP grade product that we will use in both our pre-clinical studies and Phase 1 clinical trial.”