Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) managing director James Graham sits down with Proactive’s Jonathan Jackson to discuss the successful completion of a batch production of 5,000 doses per week of its synthetic anti-infective RECCE® 327 (R327) under Good Manufacturing Practices (GMP).
This achievement highlights the company's enhanced full-spectrum manufacturing capabilities and the reproducibility of its patented process. To meet rising demand, Recce temporarily relocated its manufacturing equipment from its Macquarie Park Facility to a third-party GMP-certified cleanroom facility, allowing the increased production of R327 doses. This quantity is intended to meet the needs of ongoing clinical trials, including phases 1, 2, and the forthcoming Phase 3 trials targeting diabetic foot ulcer infections.
Each produced dose meets the rigorous standards required for human clinical trials, mandated by regulatory authorities such as the US Food and Drug Administration (FDA). Arthur Kollaras, Recce’s head of manufacturing, expressed excitement over this significant step towards combating antimicrobial resistance. This production milestone is also pivotal for the company’s upcoming investigational new drug (IND) submission. GMP certification ensures the consistent quality of the medicines produced, which is vital for patient safety and treatment efficacy, covering every production aspect from raw materials to staff training and hygiene.