Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) has ramped up its patented manufacturing process, completing batch production of 5,000 doses per week of its synthetic anti-infective RECCE® 327 (R327) under Good Manufacturing Practices (GMP).
Proof of capability
The successful batch is a first for Recce’s full-spectrum manufacturing capability that demonstrates the versatile, reproducible nature of its patented manufacturing process.
Due to the increased demand, the company temporarily transported its manufacturing equipment from its Macquarie Park Facility to a third-party cleanroom-GMP facility.
From here it was able to produce an increased quantity of 5,000 R327 doses, including the final step of the manufacturing cycle – fill and finish.
The quantity is sufficient to support demand from ongoing clinical trials for R327, including Phase 1, Phase 2 and the upcoming registrational Phase 3 trials aimed at treating diabetic foot ulcer infections.
Standard for human trials
Each dose adheres to the stringent standards required for human clinical trials by regulatory authorities like the US Food and Drug Administration (FDA).
Recce’s head of manufacturing Arthur Kollaras said: "We are thrilled to announce the successful batch completion of human pharmaceutical grade R327, representing a crucial step forward in our mission to address the global threat of antimicrobial resistance."
The production milestone marks a key step towards the coimpany's investigational new drug (IND) submission.
GMP certification is critical and covers all aspects of production to ensure consistent medicine quality, crucial for the safety and efficacy of treatments provided to patients.
It covers all aspects of production, from the starting materials, premises and equipment to the training and personal hygiene of staff and prevents errors that cannot be eliminated through quality control of the finished product.
Without GMP, it is impossible to be sure that every unit of a medicine is of the same quality as the units of medicine tested in the laboratory.