Responsible Sourcing at CGT Global

Ethical Collection. Transparent Practices. 

At CGT Global, we uphold a strict commitment to the ethical, legal, and responsible sourcing of all human biological materials. We recognize that our clients—researchers, clinicians, and biotechnology leaders—demand integrity and compliance at every stage of their supply chain. We also understand the importance of being transparent with the public about our sourcing practices.

This page outlines what we do when it comes to sourcing materials for advanced cell and gene therapy applications.

What We Source

We only collect and provide the following material types:

  • Peripheral blood from healthy adult donors

  • Mobilized Leukopaks using standard, IRB-approved mobilization protocols

  • Bone marrow from healthy adult volunteers

  • Cord blood, exclusively from full-term deliveries with maternal consent

  • Fresh and cryopreserved immune cells, derived from the above collection

Informed Consent and IRB Oversight

All donor materials are collected under Institutional Review Board (IRB)-approved protocols that meet or exceed federal regulations for human subject research.

Our IRB protocols include:

  • Independent ethical review by a federally registered IRB, ensuring that all collection procedures are in compliance with U.S. Department of Health & Human Services regulations (45 CFR 46).

  • Documented informed consent from each donor, including:

    • A clear explanation of the purpose of donation

    • How donated material may be used in research or manufacturing

    • The voluntary nature of participation and the donor’s right to withdraw consent

  • Privacy and confidentiality protections in compliance with HIPAA and 21 CFR Part 50

In the case of cord blood collections, CGT Global only collects material after full-term deliveries and with separate consent from the mother. No materials are collected from pre-term births or elective procedures.

Our protocols are reviewed and renewed on a regular schedule, and every donor encounter is documented and traceable according to Good Tissue Practice (GTP) guidelines.

Compliance and Regulatory Framework

Our collections and operations are conducted within CGT Global’s FDA-registered, CLIA-certified facilities. We adhere to:

  • 21 CFR Part 1271 for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

  • Good Tissue Practices (GTP)

  • HIPAA and applicable state privacy laws

  • Internal SOPs that exceed minimum federal compliance requirements for quality, traceability, and donor safety