ReceptoPharm achieves ISO Class 5 cleanroom certification
Drug discovery firm ReceptoPharm, a subsidiary of Florida, US-based Nutra Pharma, has achieved ISO Class 5 certification for its cleanroom manufacturing and laboratory facility. The upgraded ReceptoPharm facility is used primarily for the development and production of RPI-78, RPI-78M and RPI-MN, the firm’s leading drug candidates for the treatment of Multiple Sclerosis (MS), Adrenomyeloneuropathy (AMN), HIV, pain, and rheumatoid arthritis.
"Achieving ISO Class 5 certification is an important milestone for our clinical development programme," said Dr Paul Reid, chief executive of ReceptoPharm. "It not only shows our long-term commitment to adopting the highest quality standard for our operations, but also provides us with greater control over our drug production capabilities."
In addition to maintaining higher quality standards, completing the ISO certification process means significant cost savings for an operation that was previously contracted out to third parties. More specifically, the company has been approved to complete its own sterile drug fills for upcoming trials in the US and Europe.
Biotec, a UK-based firm specialising in European clinical drug import and distribution, conducted the successful ISO certification audit in February.
