This program encompasses the different perspectives from two facilities (an institution that provides GMP laboratory and manufacturing services to multiple sponsors and researchers and an academic hospital-based processing laboratory). Release testing before distribution is an important requirement ensuring patients' safety treated with cellular tissue-based products. The quality and value of these tests can be affected by many factors, including validation of tests and staff training and proficiency. Description of tests and quality control required before release and distribution either for further manufacturing or as a final (finished) product for the administration of human cellular tissue-based products (HCTPs), both minimally manipulated and more than minimal manipulation (361 and 351 type products) will be discussed in this session.
Describe the different laboratory tests commonly used for the release of HCTPs (both 361 and 351 products).
Compare common laboratory tests between the different products.
Identify regulatory requirements for release criteria.
Evaluate different techniques and implementation procedures as well as lot to lot comparison, when appropriate.
Director, Cell Therapies Manufacturing Facility,
Hackensack University Medical Center
MT, SBB, HP (ASCP) CABP (AABB),
Assistant Operations Director of the Cell Therapy Facility,
Moffitt Cancer Center