Clinical Leukopaks, Fresh
StemExpress Clinical Leukopaks are GMP-compliant and intended for use in Cell Therapy manufacturing processes. Clinical Leukopaks are and collected from IRB-approved consented healthy donors at 6 coast-to-coast FDA registered collection centers by qualified and trained staff using the Terumo Spectra Optia cMNC collection protocol. Donor eligibility is determined following the AABB approved Donor History Questionnaire for Hematopoietic Progenitor Cells (HPC-DHQ) and in compliance with FDA 21 CFR Part 1271 subpart C for infectious disease testing and physical examination. StemExpress laboratories are FDA and CLIA registered and standard infectious disease testing is performed by a qualified provider using FDA-licensed test methods.
Full Clinical Leukopak collections target a minimum 10 Billion TNC yield and ≥ 90% viability and are shipped fresh for same day, overnight or international delivery and documentation provided is customizable and compliant with GMP. StemExpress Quality Assurance reviews each batch for accuracy and release.
For more information or a custom project evaluation, request more information.
|Cell and Tissue Source|
Zika NAT* inquire, HCV Ab, Additional Testing* inquire, HBV Ab Core + Reflex, HBV Ab Surface Ag + Reflex, HTLV I & II Ab + Reflex, Syphilis Ab, West Nile Virus NAT, T. Cruzi (Chagas) Ab, CMV Total, CMV Total with Reflex to IgM (Only performed if CMV total test result is positive), HIV I & II Ab + Reflex, CMV Total with Reflex to IgM and IgG/IgM (Only performed if CMV total test result is positive), HIV/HBV/HCV NAT