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The Belgian biotechnology company Cardio3 BioSciences (C3BS), a leader in the discovery and development of regenerative and protective therapies for the treatment of cardiac diseases, today announces 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.
GMPs are regulatory requirements that provide guidelines for necessary processes, procedures and documentation to assure that pharmaceutical products are consistently produced and controlled to the quality standards appropriate to their intended use. The FAMHP inspected Cardio3 BioSciences’ Mont-Saint-Guibert facilities to certify such continued compliance.
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.”
Cardio3 BioSciences is a Belgian leading biotechnology company focused on the discovery and development of regenerative and protective therapies for the treatment of cardiac diseases. The company was founded in 2007 and is based in the Walloon region of Belgium. Cardio3 BioSciences leverages research collaborations in the US and in Europe with Mayo Clinic and the Cardiovascular Center Aalst, Belgium.
The Company’s lead product candidate C3BS-CQR-1 is an innovative pharmaceutical product consisting of autologous cardiac progenitor stem cells. C3BS-CQR-1 is based on ground breaking research conducted at Mayo Clinic that allowed discovery of cardiopoiesis, a process to mimic in adult stem cells the natural signals triggered in the early stages of life during the cardiac tissue development. Cardio3 BioSciences has developed C-Cath®, the next-generation injection catheter with superior efficiency of delivery of bio therapeutic agents into the myocardium.
Source: Cardio3 Biosciences