The completion of construction works, procurement and equipment testing is a critical milestone for producing a higher standard of product accordingly to the US Food and Drug Administration’s (FDA) Good Laboratory Practice (GLP) guidelines for remaining preclinical tests and beyond.
The new automated manufacturing process developed by Recce has been constructed using off-the-shelf components including the latest bioreactor technology by German pharmaceutical equipment manufacturer, Sartorius Stedim Biotech, saving on development costs, lead times and certifications.
For the first time, Recce’s manufacturing process transitions from a manual laboratory method to automated in-house production. Early indications support extraordinary production economies and scalability.
Early testing by Chief Chemical Engineer Arthur Kollaras has shown expected production outputs of 1 L per day of RECCE 327 with yields in the order of 99-100%.
The manufacturing process includes a computer controlled reaction vessel, monitoring all process parameters, with a connected sterile packaging unit expected to produce at the current scale of around 50 x 150mL drip bags per week.
This is more than capable of servicing both Phase I and II clinical testing, and is expected to meet name-plate production standard within 4 weeks.
The remaining commissioning of the plant will ensure the systems and processes that have been developed and implemented within the Perth facilities are now extended to include automated manufacture at high pharmaceutical standards in Macquarie Park.
Recce Executive Chairman, Dr Graham Melrose, said: “The business now has a world-class manufacturing facility designed to supply FDA-standard batches of our synthetic antibiotic, RECCE 327, for anticipated clinical trials. Automating the manufacturing process is cost-efficient and ensures product of the highest quality."
