About GMP PBMCs from Charles River

Our fresh and cryopreserved GMP PBMCs complement our existing Research Use Only (RUO) PBMC offerings, providing you with readily available CGMP-compliant isolated mononuclear cells.

GMP PBMCs are offered with either standardized protocols (CliniPrime™ PBMCs) or customizable options (GMPrime™ PBMCs), and they are available in both fresh and cryopreserved formats. All GMP PBMC products maintain strict GMP compliance throughout the collection process and meet all regulatory standards from process development to commercialization. 

Why Choose Charles River?


Explore GMP PBMCs: Fresh and Cryopreserved

GMP PBMCs are available in fresh and cryopreserved formats, with two flexible options to support your needs.

Need help choosing? Connect with a specialist

Fresh and Cryopreserved GMP PBMCsCliniPrime™
GMP PBMCs		GMPrime™
GMP PBMCs
Application
Process Development → PreClinical → Clinical Phases → Commercialization		blue check markblue check mark
Standardized Protocol
Standard Master Batch Record (MBR) and workflows for quicker access to GMP material		blue check mark 
Fully Customizable Protocol
Custom Master Batch Record (MBR) with process deviation from Charles River Standard Operating Procedures (SOPs)		 blue check mark
Quality Assurance and Regulatory Compliance
Compliant with 21 CFR 1271, 210, 211, and international regulatory requirements for HCT/Ps as applicable. We maintain accreditation and licensure by the FDA, AABB, CLIA, EMA, and PMDA standards.		blue check markblue check mark
Donor Recruitment and Management
Donor selection and screening		blue check markblue check mark
Donor Infectious Disease Testing Panelblue check markblue check mark
Manufacturing
Processed using a closed and automated system in a cleanroom environment.		blue check markblue check mark
Product Testing
(e.g., Sterility, Mycoplasma, Endotoxin, etc.)		blue check markblue check mark
Cellular Characterization Data
(e.g., Flow Cytometry)		blue check markblue check mark
Packaging
Conveniently packaged in bags. Vials are available upon request.		blue check markblue check mark
Qualified Shipping Courierblue check markblue check mark

To receive further detailed product specifications, contact us 

digital image of natural killer cells targeting cancer cells

Optimize Cell Therapy Manufacturing Efficiency with Cryopreserved Cells
View this webinar to learn how purified and cryopreserved cell populations streamline logistics, reduce variability, and enhance transduction efficiency in CAR-T production.
Watch on Demand

 

4 Reasons to Choose Charles River for GMP PBMCs

1. Unmatched Quality and Compliance

All GMP PBMC products are processed using a closed and automated system in a cleanroom environment, ensuring the highest safety, traceability, and reproducibility standards.

Our GMP PBMC products are quality-assured, regulatory-compliant, and CGMP-manufactured under rigorous SOPs. They ensure superior quality, yield, and purity of mononuclear cells while significantly minimizing the presence of unwanted cells, such as granulocytes, red blood cells, and platelets, that can affect the viability and functionality of the MNCs.

2. Global Reach, Local Support

With a worldwide distribution network and dedicated scientific support, we deliver GMP PBMC solutions wherever your research takes you.

3. Customizable Solutions

Tailor your order to your specifications – donor selection and recruitment, processing, and delivery options are all designed to fit your unique research needs.

4. Trusted by Leaders

Join the world’s top scientists and institutions who trust Charles River for their cell therapy research and advanced therapies.


Ready to Accelerate Your GMP PBMC Research?

Experience the difference with our fresh and cryopreserved GMP PBMCs portfolio. Contact us today to discuss your project, and let us help you take your research to the next level.

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Frequently Asked Questions (FAQs) About Human GMP PBMCs

  • Can I buy cryopreserved GMP PBMCs in vials?

    Yes, cryopreserved GMP PBMCs are available for purchase in vials, upon request. If you’re interested in purchasing GMP PBMCs in vials, please contact us.

    Related products:

  • What are the benefits of using GMP PBMCs as starting material for cell therapy development?

    The primary benefits of using GMP PBMCs as starting material would be a lower risk of expanding unwanted cell types (especially in the case of oncology), using less vector because certain cell types will bind (platelets) or eat (macrophages) vector, causing you to need more to achieve the same transduction efficiency. 

    Additionally, the amount of vector added is based on the total number of viable cells, so if you are using a mixed population, you would need more vector than if you just had the isolated target cells (i.e., T-cells).

    We've found that purified starting material does better when freezing/thawing and shipping.

  • I’m ready to move forward with my GMP project. What is needed from me prior to my first GMP PBMC collection?

    Before the initial collection, our clients are required to provide the GMP PBMC documentation items listed below:

    CDA/NDA
    Confidential Disclosure Agreement / Non-disclosure Agreement    		A contract that protects against the unauthorized disclosure of confidential information and requires both parties to keep specified information confidential. The parties involved must maintain the confidentiality of any proprietary information under the agreement.
    MSA
    Master Sales Agreement    		A contract that establishes the terms and conditions that govern all current and future activities, agreements and responsibilities between parties.
    CRQ
    Customer Request Questionnaire    		A document outlining product requirements as specified by the requestor/client. This includes donor demographics, testing requirements, and any additional specifications required.
    QTA
    Quality Technical Agreement    		A document that defines quality parameters and responsibility for their execution. The level of detail varies depending on the project's development phase.
    SOW
    Statement of Work    		A document that describes the requirements for a given project. It outlines project-specific activities, the scope, timeline and deliverables of a project. The document will also include standard regulatory and governance terms and conditions, requirements, and pricing.
  • How soon can I expect to receive my shipment of GMP PBMCs?

    Shipping will vary depending on the scope of your GMP project. Please contact us to further discuss GMP timelines.