Clinical Grade Non-Transfusable Human Primary Cells
Clinical Grade Non-Transfusable Human Primary Cells are high-quality cells that follow the same strict regulations as GMP grade products regarding the collection, processing, analysis, and storage as well as the data associated with the administrative and operational processes. These primary cells are ideal for the development of medical devices, animal studies, and pre-clinical experiments where a high-quality product is desirable to prevent unwanted experimental variables.
Clinical Grade Non-Transfusable Human Primary Cells are for Research Use Only.
Clinical Grade Non-Transfusable Products
StemExpress facilities comply with strict FDA guidelines regarding the production, processing, and management of human tissue-based cellular products to ensure the overall quality of each product.
- Adhere to IRB-approved consent forms and protocols in accordance with FDA CFR 21 Part 50 and 56
- Tissue collections take place on an FDA approved closed, continuous-flow apheresis system or using aseptic techniques with reagents and components manufactured under ISO 13485 certified quality system
- Cell isolations occur within a Cell Manufacturing Facility that follows GMP guidelines and uses reagents, components, instruments, and buffers that are manufactured under ISO 13485 certified quality system
- Cell manipulation procedures are performed inside ISO 5 air quality processing chambers
- Entire process is managed using FDA CFR 21 Part 11 compliant Enterprise Resources Planning software (ERP) and Quality Management System (QMS)
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.
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.
Primary cells are very sensitive to many aspects of the thawing procedure, such as heat, DMSO, agitation, and high centripetal forces. Obtaining high viability after thawing human primary cells can be difficult if not performed quickly and with good laboratory techniques. At StemExpress, our laboratory technicians have years of experience handling and thawing frozen human primary cells and have designed a procedure that will help you obtain the highest viability of your cells. Click Thawing Protocol to access the protocol.
All over the world. We have a variety of shipping methods to meet your needs. Please inquire for more information.