By: Joanna Wirkus
Despite exponential progress in the field of biology, inherited and preventable diseases continue to burden billions of people worldwide. Bridging the gap between laboratory discoveries and transformative clinical therapies remains a significant challenge, , and an urgent opportunity. High-quality biospecimens are foundational to this effort, enabling the advancement of cell and gene therapy research and powering the development of next-generation treatments like CAR-T cell therapy for life-threatening conditions like hematopoietic malignancies.
For over 15 years, scientific innovators across the global cell and gene therapy community have relied on CGT Global for critical clinical-grade blood products and specialized services. By delivering expertly managed donor solutions and high-quality, cGMP (certified Good Manufacturing Practice) whole blood and Leukopaks, CGT Global drives the accelerated development of life-changing biologics-based treatments. Our integrated clinical capabilities support the end-to-end pipeline of therapy development, t—from preclinical research through to commercial-scale manufacturing, —empowering our partners to move from discovery to delivery with confidence.
Services
Clinical donor recruitment:
Research centers developing off-the-shelf allogeneic therapies rely on a consistent, high-quality supply of cellular starting materials. A dependable cell supply chain is critical to advancing cell and gene therapy clinical trials, securing regulatory approvals, and scaling for long-term commercial success. The development of safe and effective therapies is time-intensive and costly, requiring the orchestration of multiple moving parts, including products, protocols, and personnel.
Delegating healthy donor recruitment to CGT Global’s Contract Research Organization (CRO) allows research teams to concentrate on core scientific and operational priorities, such as manufacturing, delivery, and clinical oversight, while we manage the logistics of donor engagement and management. Our large, pre-screened, and diverse donor pool can be tailored to protocol-specific needs, offering customized demographic selection and reliable repeat donors. Scientists who leverage our recruitment expertise and recallable donor network reduce their drug development timelines and accelerate the path to market by months to years. By collaborating togethercollaborating, we can deliver life-changing treatments sooner, providing patients with renewed hope and enhanced quality of life.
Clinical donor screening:
Cell and gene therapy innovators navigate high risks to deliver life-changing rewards. Patients' lives depend on accurate, thorough screening of healthy donors for clinical-grade products. The procedures necessary to determine donor eligibility are important, involved, and costly. To address the need for pre-qualification of clinical donors—a critical requirement in the industry—we have streamlined procedures for adhering to the FDA’s Donor Eligibility regulations under Title 21 Code of Federal Regulations (CFR) part 1271 subpart C (Title 21).
- Donor screening on paper: Vetting donors includes an extensive inquiry into lifestyle-related risk factors and their medical history. Eligibility is determined following the American Association of Blood Banks (AABB) Hematopoietic Progenitor Cell-Donor History Questionnaire (HCP-DHQ).
- Donor blood testing: All donors undergo a physical examination and are tested within 7 days of donation for relevant communicable diseases (HIV, Hepatitis B & C, HTLV, CMV, and others) using FDA-approved testing methods conducted in a CLIA-certified laboratory, complete with rigorous, regulatory-compliant documentation. Additional infectious disease testing can be customized to align with the specific needs of your specialized protocols.
- Beyond basic eligibility, we offer scientists options to further characterize important biologic variables including donors’ ABO RhD typing, HLA, KIR, and genomic screening.
Once donors are deemed eligible, they provide informed consent under ethical oversight, in accordance with IRB-approved forms and procedures. We guarantee that all products will be delivered on time, with a backup donor on standby to prevent any potential delays.
With our skills and expertise, we are dedicated to helping scientists find the right donors for their translational research initiatives. With customizable donor recruitment and screening services, we offer both research use only (RUO) and clinical-grade GMP whole blood, Leukopaks, and cryopreserved PBMNCs. The FDA closely scrutinizes the sourcing of human biospecimens along the research pipeline, so choosing the same vendor for RUO and GMP products is crucial for IND approval.
Why take unnecessary risks with internal donor recruitment and screening when it demands highly trained labor, time, and capital? Eliminate the headaches by outsourcing your GMP biospecimen acquisition to our experienced team. Our professionals handle the key quality control and compliance requirements, allowing your scientists to focus on research priorities—introducing transformative therapies to patients.
cGMP Leukopaks and Whole Blood
Screened and eligible donors come into our state-of-the-art collection clinics for leukapheresis or phlebotomy. Leukapheresis is conducted with highly trained apheresis technicians using the Terumo Spectra cMNC collection protocol into ACD-A anticoagulant bags. The goal is to collect at least 10 billion TNC with ≥90% cell viability per Leukopak. For cGMP whole blood, skilled phlebotomists can collect 250 mL per bag with CPD anticoagulant.
Considering donor-to-donor differences, we characterize and document the percentages for different cell-type populations in each Leukopak so scientists can benefit from predictability and optimize batch-to-batch comparability for downstream isolations and assays.
cGMP Cell Isolations (Coming Soon)
CGT Global’s laboratory houses a CliniMACS Prodigy®, an automated, closed-system platform that enables cGMP-compliant cell isolation without the need for a full-scale GMP lab. It performs cell washing and fractionation with magnetic bead-based enrichment or depletion in a streamlined, sterile process—supporting any cell type isolation without compromising function. Standard protocols and kits are included, with options for full customization. A temperature-controlled chamber supports cell culture and expansion, media changes, and gentle centrifugation, while a built-in microscope allows for real-time monitoring.
By connecting leukapheresis directly to cell separation, the system eliminates environmental exposure and contamination risk. Its standardized workflows reduce human error, support scale-up, and ensure consistent, high-quality manufacturing of autologous and allogeneic cell therapies. FDA-approved and ISO 13485–certified, CliniMACS offers a complete solution for healthcare facilities without dedicated GMP infrastructure.
GMP Shipping and Delivery
For all our clinical-grade products, we provide GMP-compliant shipping, including same-day, overnight, and international deliveries to research centers locally and globally. Frozen and fresh biospecimens are shipped in temperature-controlled, validated shippers with temperature monitoring and data collection to ensure quality control throughout transport. The proper temperature of cryopreserved products is maintained in dry cryogenic shippers with vapor-phase liquid nitrogen, protected from movement and breakage during transit with cassettes and racks. Specialty couriers deliver products directly to research facilities immediately after air transport, ensuring expedited shipment timelines. Customization options for cGMP-compliant documentation, shipping containers, and carriers are available to meet the specific needs of each project.
Accelerating Your Cell & Gene Therapy Program
You’re doing important work; let’s work together to bring life-saving therapies to market faster.
Are you ready to partner with collaborators who understand the high stakes and complex demands of cell and gene therapy development? CGT Global has been supporting scientists leading medical innovation in biotech, pharma, and academia for 15 years, providing donor management, human biospecimen procurement, and primary cell isolations. Our three FDA- and CLIA-certified Stem Cell Collection Centers—located in the US (Folsom, CA; East Norriton, PA; and Boston, MA)—include collection clinics co-located with cell processing laboratories, ensuring quality and high cell viability through rapid sample processing. Our optimized recruitment and screening protocols have established the industry’s largest donor pool—diverse, recallable, and well-characterized—giving you streamlined access to the high-quality biological materials essential for bringing your novel biologics-based therapeutics to market faster. Equipped with RUO and GMP capabilities, we look forward to supporting your translational research throughout the therapeutic commercialization continuum, from development to scalable post-approval rollout. Backed by a proven track record in navigating international customs regulations and managing cold supply chain logistics, we deliver key materials for cell and gene therapy development locally and globally. We pride ourselves on going above and beyond to meet the needs of our research collaborators, offering many options for customization.
Need donor management services or clinical grade biospecimens for cell and gene therapy development? Contact our team today to discover how partnering with CGT Global’s Clinical Solutions will accelerate the development of your next life-changing therapy.
List of Abbreviations
ABO – ABO Blood Group System
ACD-A – Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A
CFR – Code of Federal Regulations
cGMP – current Good Manufacturing Practice
CMS – Center for Medicare & Medicaid Services (CMS)
CGT – Cell and Gene Therapy
CLIA – Clinical Laboratory Improvement Amendments Law of 1988, regulatory compliant
CMV – Cytomegalovirus
cMNC – Circulating Mononuclear Cells
CPD – Citrate Phosphate Dextrose
CRO – Contract Research Organization
FDA – Food and Drug Administration
HCT/P – Human Cells, Tissues, and Cellular and Tissue-Based Products
HIV – Human Immunodeficiency Virus
HLA – Human Leukocyte Antigen
HTLV – Human T-cell Leukemia Virus
IND – Investigational New Drug
IRB – Institutional Review Board
ISO – International Organization for Standardization
KIR – Killer-cell Immunoglobulin-like Receptors
PBMNC/PBMC – Peripheral Blood Mononuclear Cells
RhD – Rhesus D Antigen
RUO – Research Use Only
SOP – Standard Operating Procedure
TNC – Total Nucleated Cells
WBC – White Blood Cell
