Cardio3 BioSciences Granted GMP Certification

16-Apr-2012 - Belgium

Cardio3 BioSciences (C3BS) announced that it has been granted Good Manufacturing Practice (GMP) Certification for its new production facilities in Mont-Saint-Guibert. Certification was granted by the Federal Agency for Medicines and Health Products (FAMHP), the authority responsible for the quality, safety and efficacy of medicines and health products in Belgium.

The Mont-St-Guibert production facilities are used in the manufacture and testing of Cardio3 BioSciences’ lead product C3BS-CQR-1, a regenerative therapy currently in development for the treatment of heart failure.  C3BS-CQR-1 is expected to enter a Phase III study in 2012.

Dr Christian Homsy, CEO of Cardio3 BioSciences, said: “We’ve followed GMP guidelines from the start of our activities and are very pleased to have demonstrated, via this recent audit and registration and also our recent ISO certification for our cardiac catheter work, our continuing commitment to quality practices. Gaining GMP certification from the health authorities is also a key step for Cardio3 BioSciences ahead of our planned Phase III trial for C3BS-CQR-1, a product we believe offers a potentially revolutionary new approach for the treatment of heart failure, one of the world’s most significant unmet medical needs.”

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