Clinical Grade Non-Transfusable Products
From the initial phase of discovery and development to preclinical research and on into the final phase of clinical trials, the use of StemExpress' Clinical Grade Non-Transfusable products provide a smooth and easy transition from laboratory prototype to commercial production and can ease the path through the FDA approval process making time-to-market achievable in a shorter period of time. These Clinical Grade Non-Transfusable products are ideal for the development, design, and control of studies relating to transplantation, cell therapy, regenerative medicine, investigational new drugs, and medical device production.
Clinical Grade Non-Transfusable human tissues are collected using clinical consent forms, reagents, and components. The collection of StemExpress’ Clinical Grade Non-Transfusable Leukopaks® and Clinical Grade Non-Transfusable Mobilized Leukopaks® takes place on an FDA approved closed, continuous-flow apheresis system. In addition, Clinical Grade Non-Transfusable Bone Marrow, 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.
Clinical Grade Non-Transfusable Human Primary Cells are isolated in a cell manufacturing facility that adheres to cGMP guidelines. Cell culture procedures, including open manipulation of vials, final filling, and closure of finished products, are performed inside ISO 5 air quality processing chambers, which are located within a cell manufacturing facility. 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.
StemExpress facilities comply with strict guidelines regarding the production, processing, and management of human tissue-based cellular products to ensure overall quality. StemExpress’ facilities follow FDA CFR 21 Part 1271 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 as well as Good Laboratory Practices (GLP) FDA CFR 21 Part 58 assuring the quality and integrity of the data collected. Each facility operates under strict, approved standard operating procedures (SOPs) and is 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 Institutional Review Board (IRB) in accordance with FDA CFR 21 Part 50 and 56.
Why use Clinical Grade Non-Transfusable products for your research?
Clinical Grade Non-Transfusable products adhere to the same regulations as clinical grade transfusable products in regards to GMP guidelines, documented training, QA issued production records, dedicated production preparation, testing and release of raw materials, analytical method qualification, dedicated supplies, and validated cleaning methods. These high-quality products ensure the integrity and clinical relevance of the data being collected by eliminating irreproducible results and misinterpretation of the data in the research and preclinical stages of development, which can lead to failure of clinical outcomes and setbacks to market launches.
Frequently Asked Questions
- Procures healthy and diseased human tissue and blood
- Isolates cells
- Processes whole blood (umbilical cord, adult peripheral, and maternal)
- Cultures selected cell types
- Isolates DNA and RNA
- Conducts immunophenotyping using flow cytometry
Although StemExpress' Clinical Grade Non-Transfusable products follow FDA guidelines they are not an FDA approved product and cannot be used in humans.
Clinical grade non-transfusable products are collected using FDA approved clinical grade reagents and components that are manufactured and controlled under an ISO 13485 certified quality system, while research grade products are collected using research grade reagents and components.
Although they are not GMP grade products, StemExpress' Clinical Grade Non-Transfusable products are GMP-quality and are designed to help researchers and clinicians transition smoothly from a laboratory setting to clinical trials. Read our blog to learn more about the importance of using GMP-quality products.
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