Recce Pharmaceuticals has completed the transport of its manufacturing equipment to third-party GMP cleanroom for an increased batch production.
The Australia-based company developing a new class of synthetic anti-infectives, has completed a new batch under Good Manufacturing Practices (GMP) for its lead candidate, RECCE (registered trademark) 327 (R327), with the patented manufacturing process now producing 5,000 GMP doses of R327 per week.
"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," said Arthur Kollaras, Head of Manufacturing of Recce Pharmaceuticals.
A special case
This week, the company temporarily transported its manufacturing equipment from its Macquarie Park Facility to a third-party cleanroom-GMP facility.
In this cleanroom, Recce produced an increased quantity of 5,000 R327 doses under GMP, including fill and finish, the final step of the manufacturing cycle.
The manufacturing process is normally completed in-house, where the product is then transferred to a specialist cleanroom facility for GMP fill and finish.
Due to the increased demand for R327 required for clinical studies, producing 5,000 doses of R327 per week is a significant achievement that provides surplus sample material for current Phase 1 and Phase 2 trials and an anticipated future registrational Phase 3 study for diabetic foot ulcer infections.
The manufacturing process is normally completed in-house, where the product is then transferred to a specialist cleanroom facility for GMP fill and finish
This marks a first for Recce’s full-spectrum manufacturing capability, which includes demonstrating the versatile, reproducible nature of its patented manufacturing process.
GMP certification signifies compliance with rigorous guidelines set by regulatory authorities, including the US Food and Drug Administration (FDA), ensuring these doses can be used in Recce's clinical trials. This progress not only emphasises the commitment to advancing this innovative antibiotic for patients in need but also represents a significant step toward the Company’s Investigational New Drug (IND) submission.
GMP covers all aspects of production, from the starting materials, premises, and equipment to the training and personal hygiene of staff. It 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 medicine is of the same quality as the units tested in the laboratory.
