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.