Recce Pharmaceuticals (ASX:RCE) is trading up more than 6 per cent after producing a 5000-dose batch of its new antibiotic RECCE 327 (R327) under Good Manufacturing Practises (GMP) standards.
What it means is its patented manufacturing process has proven capacity to produce 5,000 doses of R327 per week, supporting the Phase I, II and planed Registrational Phase III clinical trials under GMP certification. GMP sees the company comply with rigorous guidelines covering materials, premises, manufacturing equipment, staffing and hygiene, ensuring quality control.
Recce’s Head of Manufacturing, Arthur Kollaras, said it represented ‘a crucial step forward in our mission to address the global threat of antimicrobial resistance’.
To reach the milestone, the company temporarily relocated its manufacturing equipment from its Macquarie Park Facility, NSW, to a third-party cleanroom-GMP facility, where production was ramped up.
The company reported the temporary relocation allowed for the heightened production requirements, whereas the manufacturing was normally done in-house and then transferred to a specialist clean room facility for GMP fill and finish.
It marks a first for the company, ‘demonstrating the versatile, reproducible nature of its patented manufacturing process’.
It has allowed surplus sample material to support multiple ongoing Phase I and Phase II trials, as well as an anticipated Registrational Phase III Diabetic Foot Ulcer Infection study.
GMP certification ensures compliance with regulatory guidelines, including those set by the US Food and Drug Administration (FDA), enabling the use of these doses in Recce’s human clinical trials.
The company claims it’s ‘a signficant step towards the company’s Investigational New Drug (IND) submission’.
RCE shares last traded at 52.5c.