PROCESSING FACILITY

OUR CLEANROOMS

Processing is performed in fully validated, certified and classified Processing ISO Class 5 Isolator inside an ISO Class 7 and Class ISO 8 rooms. All cleaning activities, manufacturing steps, materials, packaging, monitoring and processes are fully monitored by quality control.

STATE OF THE ART PROCESSING

One Biologics is dedicated to advancing 361 tissue allograft development and delivering top-notch, safe, and efficient products to the market. We adhere to the highest standards set by the FDA, the state, and AATB standards, and we are committed to managing the Gift of Life responsibly to provide maximum benefits to patients.

QUALITY ABOVE ALL ELSE

One Biologics is a registered organization with the U.S. FDA CBER for Allograft (HCT/P) manufacturing. All products are processed from human tissue that has been donated, recovered, screened, and tested for infectious diseases. The suitability of the tissue for transplantation is determined by a licensed Medical Director according to all applicable FDA, AATB, and state requirements for donor eligibility and infectious disease testing.