GMP-compliant Fresh Leukopak

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

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.

Fresh Leukopak

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 CofA
Leukopak Resources
GMP Cryopreserved Leukopak
Cryopreserved Leukopaks
AllCells Cryopreserved Leukopaks are now available for all of your Clinical Grade applications.
GMP Mobilized Leukopak
Mobilized Leukopak
Mobilized, large-scale collections of Clinical grade CD34+ hematopoietic stem and progenitor cells.
GMP-Compliant PBMCs
Isolated from whole blood or leukopaks, GMP PBMCs are ideal for Clinical Grade applications.

Request a quote for your next order of high quality human primary cells.

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