New Clinical Grade Non-Transfusable Products
StemExpress, a Folsom CA-based leading supplier of human biospecimens, announces the release of Clinical Grade Non-Transfusable products to customers developing studies relating to transplantation, cell therapy, regenerative medicine, investigational new drug (IND) development, and the research and development (R&D) of medical devices in preclinical and clinical phases. The NEW Clinical Grade Non-Transfusable Products support a smooth transition from laboratory prototype to commercial production.
The new product line features:
Why use Clinical Grade Non-Transfusable products for your research?
Research into cell-based therapies, such as cellular therapy and regenerative medicine to treat and cure human diseases, have increased drastically in the last decade with over 900 clinical trials underway.1 From research to market, each new therapy takes 10-12 years and costs roughly $2.6 billion to produce, but the time and money spent do not always guarantee FDA approval.2 In fact, only a handful of therapies have been approved by the FDA within the last few years.3 Given the growing competitive market with high financial costs on the line, a smooth and speedy transition from research to the clinic is essential.
Clinical Grade Non-Transfusable products adhere to the same regulations as clinical grade products in regard 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.4
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. Each facility operates under strict, approved standard operating procedures (SOPs) and is managed using an Enterprise Resources Planning (ERP) software and an FDA CFR 21 Part 11 compliant 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.
All Clinical Grade Non-Transfusable 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 reagents and components that are manufactured and controlled under an ISO 13485 certified quality system.
Clinical Grade Non-Transfusable Primary Cells are isolated in a cell manufacturing facility that complies with GMP guidelines.
All cell isolations that occur within the cell manufacturing facility use reagents, tubing sets, instruments, and buffers that 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.
The Bottom Line
By providing a consistently high-quality, readily available commercial source of cell products that comply with FDA regulations, StemExpress helps researchers accelerate their manufacturing, scale-up production, and shorten developmental timelines to quicken the time to market and the availability for patient use.
StemExpress is a leading Biospecimen Provider of human bone marrow, cord blood, peripheral blood, mobilized peripheral blood, maternal blood, disease state products, and human primary cells. Samples are collected from our own national network of Stem Cell Collection Centers or within regionally partnered hospitals by our own procurement staff. Fresh whole samples are sent directly to our clients or quickly processed to a primary cell population at one of our on-site GLP regulatory-compliant laboratories. We streamline the entire workflow, from donor recruitment all the way to shipping the final product, guaranteeing every sample arrives with the highest purity, viability, and quality researchers need to ensure confidence in their results.
Get in touch with us to discuss your needs and see how we can support your project.
1. The Alliance for Regenerative Medicine Releases Q2 2018 Data Report, Highlighting Sector Trends and Metrics. https://alliancerm.org/press-release/the-alliance-for-regenerative-medicine-releases-q2-2018-data-report-highlighting-sector-trends-and-metrics/
2. “Innovation in the Pharmaceutical Industry: New Estimates of R&D Costs”, J Health Econ. May 2016 (47)20-33, doi.org/10.1016/j.jhealeco.2016.01.012.
3. Approved Cellular and Gene Therapy Products. https://www.fda.gov/biologicsbloodvaccines/cellulargenetherapyproducts/approvedproducts/default.htm
4. F. Atouf, “The Role of Quality Standards for Biomanufacturing Raw Materials“, BioPharm International 30 (8) 2017.