Clinical-Quality 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-quality nontransfusable products provides a smooth and easy transition from laboratory prototype to industrialized production and can ease the path through the FDA approval process making time-to-market achievable in a shorter period of time. These clinical-quality nontransfusable products are ideal for the development, design, and control of studies relating to transplantation, cell therapy, regenerative medicine, investigational new drugs (INDs), and medical device production.

Clinical-quality nontransfusable product line:

  • Clinical-Quality Nontransfusable Bone Marrow
  • Clinical-Quality Nontransfusable Leukopaks®
  • Clinical-Quality Nontransfusable Mobilized Leukopaks®
  • Clinical-Quality Nontransfusable Primary Cells

StemExpress facilities comply with strict guidelines regarding the production, processing, and management of tissue-based cellular products to ensure the overall quality of each product.

Read more about the Collection, Manufacturing, and Quality Assurance of StemExpress’ clinical-quality nontransfusable products.

Why use clinical-quality products for your research?

Clinical-quality nontransfuable products adhere to the same regulations as clinical-grade products in regards to documented training, QA issued production records, dedicated production suite 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.

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