SYDNEY, Australia - 20 July 2017: Recce Limited (ASX: RCE), a pre-clinical-stage pharmaceutical company engaged in the development of a new class of synthetic antibiotics, today announced its new automated manufacturing facility in Sydney is now producing at name-plate standard its antibiotic compounds at volumes in preparation for human clinical trials.
The delivery of the automated manufacturing process, together with the provision of facilities and staff for assurance of quality, is an important corporate and technical milestone as it will ensure sufficient, timely and quality supply of the Company’s synthetic antibiotic compounds, designed for compliance with the high standards of the US Food and Drug Administration’s (FDA) current good laboratory practices (glp).
Recce Executive Chairman Dr Graham Melrose said, “I am delighted with this on-schedule milestone towards addressing the urgent global challenges of resistant superbugs”.
The automated process, which uses the latest bioreactor technology by German Pharmaceutical equipment manufacturer Sartorius Stedim, is producing 1000 ml batches of Recce antibiotic per day or around 50 x 150 ml sterile drip bags per week. This is estimated to be enough to supply Phase I and Phase II human clinical trials.
Recce Chief Chemical Engineer Arthur Kollaras said, “Having our own new facility ensures valuable protection against the costly delays commonly experienced by drug companies, in their efforts to produce, refine or add to the capabilities of their product – limitations recently emphasised by the FDA”.
Recce Quality Manager Dr Justin Ward added, “The achievement has been done at very significant economies from alternative outside contracting – and as well, assured that the intellectual properties and their improvements stay right here in Recce”.
Recce’s manufacturing facility at Macquarie Park in NSW and their quality laboratory in the Technology Park of Bentley in WA have been enhanced by the purchase of specialised, high-quality analytical equipment and each will remain totally dedicated to the production and quality of Recce antibiotics.
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.
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