Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) has reached a significant milestone in its production capabilities with 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).
James Graham, the managing director of Recce Pharmaceuticals, discussed this achievement with Jonathan Jackson from Proactive, emphasizing the company’s advanced manufacturing capabilities and the consistency of its patented process. To meet the growing demand, Recce temporarily relocated its manufacturing equipment to a third-party GMP-certified cleanroom facility from its Macquarie Park Facility. This move has enabled the increased production of R327 doses, catering to the requirements of ongoing clinical trials, including phases 1, 2, and the upcoming Phase 3 trials targeting diabetic foot ulcer infections.
Each dose produced meets the stringent standards mandated for human clinical trials by regulatory authorities such as the US Food and Drug Administration (FDA). Arthur Kollaras, Recce’s head of manufacturing, expressed enthusiasm for this significant advancement in combating antimicrobial resistance. This production milestone is also crucial for the company’s forthcoming investigational new drug (IND) submission. 
GMP certification ensures the consistent quality of the medicines manufactured, covering all aspects of production, from raw materials to staff training and hygiene. This commitment to quality is essential for ensuring patient safety and treatment efficacy in clinical settings.
