Clinical-Quality Products

StemExpress facilities comply with strict guidelines regarding the production, processing, and management of tissue-based cellular products to ensure overall quality. StemExpress’ facilities comply with FDA CFR 21 Part 127 requirements of current Good Manufacturing Practices/Good Tissue Practices (cGMP/cGTP) regulations covering human cells, tissues or tissue-based cellular products (HCT/Ps) for the use in clinical applications. The cGMP/cGTP compliant facilities operate under strict, approved standard operating procedures (SOPs) and are managed using FDA CFR 21 Part 11 compliant Enterprise Resources Planning software (ERP) and a Quality Management System (QMS), used for blood donor management and cell manufacturing. In addition, human tissue collection protocols are approved by StemExpress’ Medical Review Board and Independent Review Board (IRB) in accordance with FDA CFR 21 Part 50 and 56.

 

Collection

Clinical-quality tissues are collected using clinical consent forms, reagents, and components. The collection of StemExpress’ Clinical-Quality Nontransfusable Leukopaks® and Clinical-Quality Nontransfusable Mobilized Leukopaks® takes place on an FDA approved closed, continuous-flow apheresis system. In addition, Clinical-Quality Nontransfusable Bone Marrow, Cord Blood, Leukopaks and Mobilized Leukopaks are collected using aseptic techniques with FDA approved clinical grade reagents and components that are manufactured and controlled under an ISO 13485 certified quality system.

Manufacturing

Clinical-Quality Nontransfusable Primary Cells are isolated in a cGMP cell manufacturing facility. StemExpress’ cGMP facility meets ISO 8 standards for air quality under static and dynamic conditions. All cell isolation components, including reagents, tubing sets, instruments, and buffers, are manufactured and controlled under an ISO 13485 certified quality system under FDA oversight. Cell culture procedures, including open manipulation of vials, final filling, and closure of finished products, are performed inside ISO 5 air quality processing chambers and are located within the cGMP facility.

Quality Assurance

Regular testing of the air handling system includes particle counts, room air volume change rate, air pressure differentials, and HEPA (High-Efficiency Particle Arresting) filter integrity, all of which consistently meet domestic and international regulatory standards for preparation of clinical-grade cell products.

Laboratory personnel receives appropriate training in aseptic technique, gowning, and line clearance. StemExpress’ line clearance SOP specifies the procedures for routine disinfection within the BSCs before and after use.

StemExpress performs in-house analytical characterization of cell products using flow cytometry. Flow cytometry quality-control functions are performed under SOPs by appropriately trained and qualified laboratory personnel. Once the primary cells are properly characterized, a controlled-rate freezer is used for the customized cryopreservation of primary cells under the most optimal conditions for maintenance of cell viability.

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