GMP Fresh Leukopak

AllCells’ GMP Fresh Leukopak products are collected by apheresis from peripheral blood of healthy donors. Our Leukopaks contain a high concentration of lymphocyte populations, T Cells, B Cells, NK Cells, and monocytes. AllCells maintains on-site, FDA-registered donor centers for the collection of all products from IRB-consented healthy donors providing customers with a streamlined process for procuring clinical grade primary cells. A Certificate of Analysis (CoA) and summary of record are provided with every order. Clinical Grade Fresh Leukopaks are only available through consultation with an AllCells Made-to-Order representative.

Diverse Donor Pool and Extensive Donor Screening
High viability and stability leukopaks
GMP qualification of SOPs and stringent quality systems
Integrated Project Management approach to meet your specific criteria

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Pre-Characterized Donor Selection Program

AllCells’ Pre-Characterized Donor Selection Program is designed to expedite the donor selection process to accelerate the advancement of cell and gene therapies to the clinic and beyond. We obtain cryopreserved mononuclear cells (MNCs) from GMP eligible donors whose donor attributes, HLA (human leukocyte antigen) and KIR (killer cell immunoglobulin-like receptor) type have been annotated. Immunophenotyping is performed on the cryopreserved MNCs using Discovery Life Sciences’ integrated analytical capabilities.

We empower our clients to seamlessly navigate the process of screening, selecting, and collecting from donors that align with their program-specific criteria. The high-resolution data also provides valuable insight into how the starting material attributes influences the final CGT product. This enables the development of more robust and controlled manufacturing processes, ensuring enhanced consistency and efficiency throughout the entire production workflow.

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Fresh Leukopak Made-to-order

AllCells' on-site GMP collection facility and GMP cleanroom enables us to offer the highest quality, made-to-order (MTO) custom products that will meet your specific needs – from specific donor attributes to cell isolation methods. The AllCells GMP team will partner with you, bringing project management expertise to define, design and deliver your donor program and product, all with regulatory oversight and following FDA guidelines.

We provide custom services at every level:

Donor Management Services
Cell Processing and Product Development
Research-specific Isolation Protocols & Technology Transfers

Technical SpecificationsTech Specs

GMP Leukapheresis Products are enriched in single-donor mononuclear cells (MNCs), allowing for scalability and reproducibility of experiments. Our products are quality controlled for cell count and viability using a validated AO/PI protocol and pass a Sterility Test in accordance with USP71 guidelines using compendial testing.

Anti-coagulant: ACD-A
Volume: NLT 280mL
Viability: NLT 90%
TNC Concentration (x106 cells/mL): NLT 26
Sterility Test (USP71): No Growth
Shipping: 2-8°C

Certificate of AnalysisC of A

Leukopak Resources

At AllCells, we believe that your success is our success. We believe that sharing our knowledge and expertise is more than a business practice, it’s a responsibility. And we believe that collaboration leads to better outcomes. Below is a collection of relevant links to Leukopak resouces including blog posts, webinars and useful protocols to help you become more efficient and more effective. Have technical questions about Leukopak products? Our Customer Success Team is standing by.