Fresh GMP Leukopaks

Two options are available for our fresh GMP Leukopaks - a standard protocol option (CliniPrime Fresh Leukopaks), which save time and resources, and a customizable option (GMPrime Fresh Leukopaks) to address your specific program needs. Both options maintain GMP compliance throughout the collection process and meet regulatory requirements from process development to commercialization.

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CliniPrime Fresh Leukopaks

Processed using a standard GMP-compliant collection protocol, CliniPrime fresh leukopaks provide GMP starting materials with the least resource investment and most rapid access.

  • About the Product

    Product Benefits:
    Benefits of a standard collection protocol include reduced time and required resources. CliniPrime fresh leukopaks offers a high-quality, fresh GMP-compliant leukopak for your program, within our most rapid timeframe.

    Application: 
    Process development → Pre-Clinical → Clinical Phases → Commercialization

    Quality Assurance and Regulatory Compliance:
    Compliant with 21 CFR 1271, 210, 211 and international regulatory requirements for HCT/Ps as applicable. We meet all relevant accreditation and licensure standards, including FDA, AABB, CLIA, EMA and PMDA. Click here for more information on our quality and regulatory standards.

    Donor Requirements:
    Click here to learn more about our unparalleled donor management and recruitment expertise to support your GMP project. 

    Shipping Information:
    Click here for information about our shipping capabilities for GMP-compliant cellular starting materials.

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GMPrime Fresh Leukopaks 

Processed using a customizable GMP-compliant collection protocol, GMPrime fresh leukopaks provide the ability to tailor the GMP leukopak collection protocol to meet your unique project needs. GMPrime fresh leukopaks may include additional donor characterization, donor testing, SOPs, staff training and validation during collection, as required by your specific project.

  • About the Product

    Product Benefits:
    Have the flexibility to implement modifications to our standard fresh GMP Leukopak collection protocol to meet the specific demands of your program. You will receive a high-quality, fresh GMP-compliant leukopak, processed in accordance with your requested requirements, while ensuring the support you need to advance your program through consultation with our in-house operations, quality, and regulatory departments.

    Application:  
    Process development → Pre-Clinical → Clinical Phases → Commercialization

    Quality Assurance and Regulatory Compliance: 
    Compliant with 21 CFR 1271, 210, 211 and international regulatory requirements for HCT/Ps as applicable. We meet all relevant accreditation and licensure standards, including FDA, AABB, CLIA, EMA and PMDA. Click here for more information on our quality and regulatory standards.

    Donor Requirements:
    Click here to learn more about our unparalleled donor management and recruitment expertise to support your GMP project.

    Shipping Information: 
    Click here for information about our shipping capabilities for GMP-compliant cellular starting materials.  

cover of the ultimate leukopak guidebook

How Much Do You Really Know About Leukopaks?
Find out what they are and why they are important for immune research and cell therapy development. Our comprehensive guide covers best practices, considerations, applications, and in-depth characterizations for leukopak collections.
Download Guidebook

Cryopreserved GMP Leukopaks

Cryopreserved GMP leukopaks can help eliminate challenges and simplify complex logistics, while maintaining stability and consistency when high-quality human raw materials are needed for clinical use. With our industry-leading cell cryopreservation expertise, leukopaks are cryopreserved and processed using GMP-compliant protocols in a cleanroom environment shortly after collection to preserve quality, maintain maximum viability, and functionality.

Our cryopreserved GMP Leukopaks are available with a standardized protocol option (CliniPrime Cryopreserved Leukopaks), to quickly obtain starting materials with less resource investment, and a customizable protocol option (GMPrime Cryopreserved Leukopaks), which allows modifications to our standard protocols to fit your specific project needs. Both options comply with GMP standards throughout the manufacturing process and meet regulatory requirements from the process development to commercialization. 

 

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CliniPrime Cryopreserved Leukopaks

Processed using a standard GMP-compliant manufacturing protocol in a cleanroom environment, CliniPrime™ Cryopreserved Leukopaks provide the most rapid access to needed GMP starting materials for clinical use with less resource investment.

  • About the Product

    Product Benefits:
    Benefits of a standard manufacturing protocol include reduced time and required resources. CliniPrime Cryopreserved Leukopaks offers a high-quality, cryopreserved GMP-compliant leukopak for your program, within our most rapid timeframe.

    Application:
    Process development → Pre-Clinical → Clinical Phases → Commercialization

    Quality Assurance and Regulatory Compliance:
    Compliant with 21 CFR 1271, 210, 211 and international regulatory requirements for HCT/Ps as applicable. We meet all relevant accreditation and licensure standards, including FDA, AABB, CLIA, EMA and PMDA. Click here for more information about our GMP complaint cleanrooms and about our quality and regulatory standards.

    Donor Requirements:
    Click here to learn more about our unparalleled donor management and recruitment expertise to support your GMP project.

    Shipping Information:
    Click here for information about our shipping capabilities for GMP-compliant cellular starting materials.

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GMPrime Cryopreserved Leukopaks 

Processed using a customizable GMP-compliant manufacturing protocol in a cleanroom environment, GMPrime Cryopreserved Leukopaks give you the flexibility to tailor our protocols when processing a cryopreserved GMP Leukopak. GMPrime Cryopreserved Leukopaks may include additional donor characterization, donor testing, SOPs, staff training and validation during manufacturing, to meet your project demands.

  • About the Product

    Product Benefits: 
    Have the flexibility to implement modifications to our standard cryopreserved GMP Leukopak manufacturing protocol to meet the specific criteria of your program. You will receive a high-quality, cryopreserved GMP-compliant leukopak, processed in accordance with your requested requirements. While ensuring the support you need to advance your program through consultation with our in-house operations, quality, and regulatory departments.

    Application: 
    Process development → Pre-Clinical → Clinical Phases → Commercialization

    Quality Assurance and Regulatory Compliance: 
    Compliant with 21 CFR 1271, 210, 211 and international regulatory requirements for HCT/Ps as applicable. We meet all relevant accreditation and licensure standards, including FDA, AABB, CLIA, EMA and PMDA. Click here for more information on our quality and regulatory standards.

    Donor Requirements:
    Click here to learn more about our unparalleled donor management and recruitment expertise to support your GMP project.

    Shipping Information:
    Click here for information about our shipping capabilities for GMP-compliant cellular starting materials.

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