Recce constructs automated manufacturing facility to support
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ASX Announcement
Recce constructs automated manufacturing facility to support clinical trials
SYDNEY 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 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 costefficient 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.
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For further information please visit www.recce.com.au or contact:
Investor Relations
Peter Williams
CFO & Company Secretary
Recce Ltd
Tel: (08) 9253 9800
Media (Australia)
Media (International)
Andrew Geddes
Sue Charles/Gemma Harris
CityPR
Instinctif Partners
Tel: (02) 9267 4511
Tel: +44 (0)20 7866 7860
E: recce@instinctif.com
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