Recce (ASX:RCE) has started producing its antibiotic compounds at volumes at its new automated manufacturing facility in Sydney in preparation for human clinical trials.
Recce® 327 is a synthetic compound being developed to fight against viruses and bacteria, including superbugs, even after repeated use.
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.
Recce can now ensure sufficient and timely and supply of its synthetic antibiotic compounds, designed for compliance with the U.S. FDA’s current good laboratory practices (glp).
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.
This is estimated to be enough to supply Phase I and Phase II human clinical trials.
Last month, Recce secured a flexible funding commitment of up to $6.05 million from The Australian Special Opportunity Fund LP (ASOF).
ASOF is managed by New York-based institutional asset manager The Lind Partners, which has made more than 50 ASX investments since 2009 including many companies in the biotech sector.
The investment gives Recce access to additional funding to support the submission of the Investigative New Drug (IND) application for Recce 327 to the U.S. FDA.