The Biologics Production Facility meets Good Manufacturing Practice (GMP) and Good Tissue Practice (GTP) regulations, which provide investigators with the environmental controls, quality management and security required for the manufacture of drugs, vaccines and human cells, tissues and cellular or tissue-based products (HCT/Ps) for medical therapy purposes.
The 20,000 square foot facility includes six individual clean room suites that achieve class 10,000 to 100 air quality as well as a completely segregated suite for other clinical projects such as xeno transplantation. These suites share a quality control laboratory for release testing of products and other assays; a media preparation room for bulk reagent production; and cleaning, disinfecting and sterilization equipment.
A comprehensive quality system is in place that applies to all projects within the facility, including controlled access, personnel and training; documentation, production and process controls; environmental monitoring; and management of occurrences, deviations, adverse events and correction action.
Other features of the facility include:
- Accreditation by the Foundation for the Accreditation of Cellular Therapy (FACT), AABB and the College of American Pathologists (CAP).
- 100 percent outside air serves 20,000 square feet of class 10,000 to 100 clean room areas dedicated to the development, scale-up and manufacturing of HCT/Ps and Investigational New Drug (IND)-regulated therapeutics.
- Fully integrated building and equipment monitoring systems provide 24-hour surveillance.
- Code of Federal Regulations (CFR) compliant electronic database systems that support supply, reagent and equipment inventory utilization, product and sample accessioning, storage and International Society for Blood Transfusion (ISBT)128 compliant labeling and bar coding.
- Continuously monitored liquid nitrogen freezers LN2 for long-term storage of cryopreserved products, supplied by a dedicated 3,000 gallon bulk LN2 supply system. Sterile processing areas that utilize an in-house USP purified water system for cleaning and terminal sterilization of reusable instruments.