Axogen, a company specializing in developing and marketing surgical solutions for peripheral nerve injuries, today announced the successful first week of processing for Avance Nerve Graft at the newly opened Axogen Processing Center (APC), in Dayton, Ohio.
The commencement of Avance processing in the APC is an important step towards the biologics validation that will support the submission of the BLA. The new 107,000 square feet facility includes ISO14644 clean rooms, internal quality labs, a surgeon and tissue agency training lab, and state-of-the-art support systems and redundancies required of high-quality, biologic processes. The APC provides up to three times the current processing capacity and was designed for future growth and expansion.
“The local team in Dayton has done an impressive job in the construction of this world-class processing center,” remarked Todd Puckett, Vice President, Manufacturing. “We have assembled an excellent team of nearly 100 employees who are deeply committed to honoring the gift of tissue donation as we continue to revolutionize the science of nerve repair. We also appreciate our partnership with the State of Ohio, the City of Vandalia, and the Dayton Development Coalition for their support in the development of the APC.”
