GMP Leukopaks Engineered for Clinical Excellence
HIGH-YIELD, HIGH-QUALITY STARTING MATERIALS TRUSTED IN CELL AND GENE THERAPY TRIALS AND MANUFACTURING.
GMP leukopaks for critical applications in cell and gene therapy, collected, processed, and delivered with unmatched precision and regulatory assurance.
Meet Your Clinical Team
Why Choose CGT Global’s GMP Leukopaks?
Pre-Clinical (RUO) vs. Clinical (GMP) Products
At CGT Global, we understand that every project is different. That’s why we work closely with each client to determine the specific compliance requirements based on how our materials will be used.
With over a decade of experience as a trusted provider of RUO and GMP-compliant healthy donor materials, we offer flexible, customizable solutions to support researchers and drug developers at every stage of their work.
Partner with CGT Global, where expertise meets flexibility.
Dependable Donors for Reproducible Science
At CGT Global, we recognize that allogeneic therapies, such as CAR-T, demand the right donor, qualified through rigorous screening and compliant with 21 CFR 1271 Subpart C. These donors must meet strict eligibility requirements and undergo extensive testing before contributing raw material for clinical manufacturing.
To address this critical need, we offer a unique, program-specific donor solution managed by our specialized donor recruitment and collection team. Whether you’re launching a new program or scaling an existing one, our team works closely with you to build a tailored strategy that supports every stage, from donor recruitment through to product fulfillment.
Start Your Program with Confidence
CGT Global will guide you through the startup and ordering process, collaborating with you to deliver a solution that fits your exact needs. Contact us today to schedule an introductory or exploratory evaluation of your program
- Location-specific donor collection in geographic proximity to your Manufacturing facility
- Complex donor screening and pre-qualification
- Specific donor recruitment or eligibility criteria
- Additional infectious disease testing (HHV6, 7, 8, Babesia, Toxoplasma, etc.)
- IRB-approved donor Informed Consent Forms (ICF)
- Supplemental Donor History Questionnaires (DHQ)
- Customized Certificate of Analysis (CoA)
- Analytical testing & other donor or collection characterization
- Shipping containers and carriers
This service includes: Leukapheresis and Whole Blood
- FDA compliant Infectious Disease Testing panels
- Additional Infectious Disease Testing provided by approved vendors
- Donor characterization including HLA, KIR, genomic screening
- Location-based donor recruitment for supply chain optimization
- Dedicated donor management to your clinical program
- Further customization by evaluation
FAQ's
Tour Our GMP Cell Processing Facility
Step inside CGT Global’s advanced GMP laboratory, where precision meets compliance. Our facility is purpose-built to support clinical-grade manufacturing, providing a controlled environment for the processing, expansion, and cryopreservation of critical cell populations.
Cryogenic Storage & Preservation
CGT Global GMP Laboratory houses LN2 cryogenic storage systems, including vapor-phase cryo tanks equipped with automated temperature monitoring and backup power redundancy to maintain sample integrity at all times. All cryopreserved materials undergo validated controlled rate freezing protocols and are tracked through our validated inventory system.
Closed-System Cell Processing with CliniMACS Prodigy®
We utilize automated, closed-system cell isolation and enrichment, minimizing contamination risk and supporting GMP-grade reproducibility. For phenotypic analysis of expanded cell populations, we employ flow cytometry. Together, these technologies support applications such as CD34+ enrichment, T-cell subset selection, and detailed immunophenotyping.
Integrated QC & Traceability
Samples move through a fully integrated workflow that includes:
- Real-time viability and phenotyping via flow cytometry
- Mycoplasma and endotoxin testing for Cryopreserved GMP Leuakopaks
- Digital chain-of-custody tracking
We welcome collaborators and clients to tour the facility virtually or in person, and witness firsthand the rigor and reliability that define CGT Global’s clinical operations.
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Clinical Leukopaks and Whole Blood Products
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GMP Fresh Clinical Leukopaks
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GMP Cryopreserved Clinical Leukopaks
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GMP Clinical Whole Blood
Select options This product has multiple variants. The options may be chosen on the product page
