About the Institute : Cellular Manufacturing Program
Cellular Manufacturing Program
Interdisciplinary Stem Cell Institute Cellular Manufacturing Program (ISCI-CMP)
Facility Description
The Cellular Manufacturing Program (CMP) exists to facilitate the translational development of cellular therapies from basic research projects to clinical practice. The goal of the CMP is to provide the rapid and safe transition of basic research ideas. This includes the qualification and testing of reagents, scale-up of methods, development of Standard Operating Procedures (SOPs), ongoing process validation, and the provision of a controlled good tissue practice (GTP) and good manufacturing practice (GMP) infrastructure and support for compiling Investigational New Drug (IND) applications.
The CMP consists of three components: a) the Cell Production Facility (CPF), b) the Development Laboratory (DL), and c) the Preclinical Laboratory (PL). Processing of clinical products requiring long term culture is conducted in the CPF, while preclinical development and scale up procedures are undertaken in the DL. Production of cellular products for animal studies is performed in the PL and includes mouse, rat, and pig products for in vitro and in vivo studies and human cell products for studies in NOD/SCID mice.
The CPF occupies approximately 2,500 square feet on the 9th floor of the Biomedical Research Building. The designated Development Laboratory occupies 640 square feet and is conveniently located next to the CPF and the PL. The PL occupies 1344 square feet of laboratory space for production of animal cell products and isolation of cell lines for research studies. The translation of such therapies requires significant development and scale up to meet the stringent clinical standards required for patient infusion. The CMP provides the resources to do this in an effort to facilitate and expedite clinical trials in patients.
Cell Production Facility (CPF)
The CPF is a restricted access (card key controlled) laboratory, in which all essential equipment is continuously monitored and alarmed. QA maintains a controlled documentation system. This system includes document change control and approval as well as document histories. Documentation in this system includes Standard Operating Procedures (SOP) and associated attachments (forms), Certificates of Analysis (C of A), specifications for critical materials, supplies and reagents, and master batch production records. The facility consists of four 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.
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.