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.
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.|