Aldagen reports that it has established a Class 10,000 clean room for GMP-certified manufacture of its cellular products. The production plant is approximately 1,000 sq. ft. and is fully validated and supported by environmental monitoring and quality control activities, according to the firm.
Aldagen notes that its stem cell isolation technology has been incorporated into the manufacturing process and the products at this facility will be used for three ongoing clinical studies. The facility has been designed and operating procedures are in place to scale up for commercial manufacture of products upon completion of the trials and approval by the FDA, according to Tom Amick, chairman and CEO of Aldagen.