Aldagen, Inc. has announced that it has established a Class 10,000 clean room for Good Manufacturing Practice (GMP)-certified manufacture of its cellular products.
The manufacturing facility is approximately 1,000 square feet and is fully validated and supported by environmental monitoring and quality control activities.
Aldagen’s stem cell isolation technology has been incorporated into the manufacturing process and the products produced 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.
“The establishment of this manufacturing facility is an important step toward the advancement of our products in clinical trials. We now have the capability to produce cellular products for multiple clinical sites. This accomplishment supports our commercial model to manufacture our own products after gaining FDA-approval,” said Tom Amick, Chairman and Chief Executive Officer of Aldagen.