GMP Products

CGT Global Clinical Leukopaks and Whole Blood are GMP-compliant and intended for use in Cell Therapy manufacturing processes. GMP 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. CGT Global laboratories are FDA and CLIA registered and standard infectious disease testing is performed by a qualified provider using FDA-licensed test methods.