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Syndey, Australia - 22 June 2017 - Recce Limited (ASX: RCE), a pre-clinical stage pharmaceutical company engaged in the development of a new class of synthetic antibiotics, today announced it has completed construction of a wholly owned production facility in Macquarie Park Sydney with expected outputs capable of supporting RECCE® 327 through both Phase 1 and Phase 2 human trials.
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 pre-clinical 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 - 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.
Chief Chemical Engineer Arthur Kollaras & Executive Chairman Dr Graham Melrose
Early testing by Chief Chemical Engineer Arthur Kollaras has shown expected production outputs of 1 litre 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 1 and phase 2 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.
About Recce Ltd
Recce Ltd (ASX: RCE) is a world-leader in synthetic-polymer compounds, particularly against all bacteria, and viruses. The RECCE® polymers have been synthesized by an extremely economic method. RECCE® polymers have shown in laboratory tests that they have continued activity against bacteria, including superbugs, even after repeated use. Recce is positioned to achieve milestones in both pre-clinical trials for FDA purposes, and the development of the manufacture of RECCE® 327. Recce has granted patents in Australia, United States, Europe, Japan and China – giving it legal monopolies, and potential financial returns, from manufacture and distribution of its products in about 80% of the world’s pharmaceutical markets for antibiotics.
Issued for and on behalf of Recce Ltd by Instinctif Partners.
For further information please visit www.recce.com.au
In order to become availible to pateints, drugs need to undergo a number of phases of clinical trials to test their efficacy and safty and to then be authorised by the drug approval organistion in each respective country. This is the FDA in the USA and N...