Description
Fresh GMP Leukopaks are collected to target a minimum 10 Billion TNC yield and ≥ 90% viability and are shipped fresh. Overnight or international delivery and documentation provided is customizable and compliant with GMP. CGT Global Quality reviews each batch for accuracy and release.
GMP Leukopaks are and collected from IRB-approved consented healthy donors at 3 coast-to-coast FDA registered collection centers by qualified and trained staff using the Terumo Spectra Optia cMNC collection protocol. We determine donor eligibility following the AABB approved Donor History Questionnaire for Hematopoietic Progenitor Cells (HPC-DHQ). Donor eligibility is 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. Our standard infectious disease testing are performed by a qualified provider using FDA-licensed test methods.
For more information or a custom project evaluation, request more information.
