Recce, a preclinical stage pharmaceutical company engaged in the development of a new class of synthetic antibiotics, announced its new automated manufacturing facility in Sydney is producing antibiotic compounds 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 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).
Arthur Kollaras, Chief Chemical Engineer at Recce, 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.”
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.
Dr Justin Ward, Quality Manager at Recce, said: “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 its 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.