Cell Production Facility (CPF)
The CPF is a restricted access (card key controlled) laboratory, in which all essential equipment is continuously monitored and alarmed. Quality Management Program is well established and maintained. This system includes monitoring of production process, approval of supply qualification, Standard Operating Procedures (SOP), equipment qualifications and quality control, product outcome and analysis. The facility consists of six separate production suites which contain a BSC, incubators, bench top centrifuge, and microscopes. The laboratory is HEPA filtered, under appropriate air handling (positive pressure) and meets class 10,000 specifications in the manufacturing suites (1-4) and class 100,000 in the general laboratory, LN2 freezer room, storage room and gown in/out areas. Laboratory equipment is cleaned and maintained according to the established quality control (QC) schedule. Open manipulations are performed in class 100 Bio Safety Cabinets (BSCs). The comprehensive quality system includes, but is not limited to, both internal and external audits, assuring compliance with the current federal (FDA) requirements (21 CFR Part 1271 & 21 CFR Part 210 & 211) and other applicable standards AABB, FACT, and JCAHO (CLIA). The quality system is organized to monitor CMP day-to-day operational and manufacturing activities, to prevent, detect and correct deficiencies that could affect donor and patient safety and the safety, purity, potency, or efficacy of manufactured products.
Facility holds 13 ongoing clinical trials with variety of conditions, ranging from cardiovascular disease, idiopathic pulmonary fibrosis (IPF), frailty, burns, brain tumor, and Schwann cells for spinal cord injury patients.
Our CPF has been actively generating human mesenchymal stem cells for several years. We follow best practices and have established processes that address the entire lifecycle of project operations starting from establishment of a contract with the Principal Investigator to project completion and close-out. Our facility has extensive experience in contract research. The Interdisciplinary Stem Cell Institute was selected as a Cell Manufacturing Facility in 2014, for the Cardiovascular Cell Therapy Research Network (CCTRN). For this grant, more than a dozen reputable cell processing facilities competed. The grant is funded by the National Institutes of Health, National Heart, Lung, and Blood Institute (NHLBI). The CCTRN network conducts research to evaluate the use of cell-based treatment strategies for people with cardiovascular disease – an area in which the Interdisciplinary Stem Cell Institute (ISCI) has been a leader in the nation since 2008. For the CCTRN grant, our CPF will manufacture MSCs from autologous bone marrow and c-kit+ cardiac stem cells (CSCs) from endomyocardial biopsies. The selection of our CPF for the CCTRN grant to produce regenerative cells is a testimony of the experience, expertise, and superior quality of work products delivered by our facility.
Our facility was recently awarded the prestigious PACT: Production Assistance for Cellular Therapies from National Heart Lung and Blood Program (NHLBI) as a facility assisting investigators nationwide in developing the pre-clinical products that will eventually translate into products to be used in clinical trials. We have built an organization that delivers excellence every day.
We are FACT accredited and are in the process of pursuing AABB accreditation. We have developed several new products in a short period of time and are actively collaborating with other leaders in the field such as University of Maryland, Cornell University, University of Indiana, Ocata Therapeutics Inc, and RxMP Therapeutics, LLC.; our team processes Schwann cells for transplant after spinal cord injury, in collaboration with the Miami Project for Cure Paralysis and, we process Dendritic cells for Sarcoma and Giloblastoma trials for the Sylvester Cancer Center. In addition, we are on target to increase cell production of our bone marrow derived stem cells to fulfill our NIH contract needs for the CCTRN Network (a nationwide network of seven centers conducting clinical trials of stem cell therapy for cardiovascular diseases).
Cell Sorting Room (CSR)
A cell sorting room is part of the CPF and meets Class 100,000 requirements. In the Flow room we have a MoFlo XDP high speed cell sorter, this instrument has the capacity to sort at speeds up to 70,000 cells per second with multi parameter sorting capabilities. The MoFlo is contained within a biosafety cabinet, so all cell manipulation and sorting is performed at class 100 level.