AllCells® GMP Cryopreserved Leukopak

Discovery’s AllCells® GMP Cryopreserved Leukopaks are collected from the peripheral blood of IRB consented donors who meet FDA 21 CFR 1271 requirements. Cells are immediately processed for cryopreservation at an adjacently located GMP ISO 7 clean room. A certificate of analysis and summary of record are provided with every order.

GMP Cryopreserved Leukopaks are available as made-to-order according to the program specific donor attributes and infectious disease marker testing, or as made-to-stock which meet standard 21 CFR 1271 donor requirements.

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AllCells® GMP Cryopreserved Leukopaks provide flexibility in both timeline and logistics without compromising quality. Our leukopaks are quality controlled for cell count and viability using a validated AO/PI protocol and pass a sterility test in accordance with USP <71> guidelines through compendial testing.

  • Catalog Number: CG, LP, CR, Solo 2.5 – 3.0B
  • Anti-Coagulant: ACD-A
  • Format: OriGen CS250 bag with target volume 70mL, minimum 3 bags per lot
  • Cryopreservation Media: Cryostor® CS10
  • Pre-Cryopreservation TNC Count per Bag: NLT 2.5 billion cells
  • Pre-Cryopreservation Cell Viability: NLT 90%
  • Retain Vials: Up to 8
  • Sterility Test USP <71>: No growth
  • Shipping Conditions: <-150°C in a validated shipping container with temperature logger
  • Documentation: Certificate of analysis, summary of records, immunophenotype report, and CBC 5-part differential report

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 Project Managers are standing by.

WEBINARS
BLOG POSTS
RESOURCES

Our GMP Cryopreserved Leukopak Difference

  • Seamlessly transition from process development to manufacturing with AllCells® RUO and GMP Cryopreserved Leukopaks
  • Build a robust manufacturing process with high quality cells, ensured by minimal time between collection to processing and validated cryopreservation protocols, to yield high cell viability and low granulocyte contamination
  • Maximize downstream manufacturing success by effectively screening, selecting, and retaining donors with desired attributes
  • Accelerate timelines with off-the-shelf GMP Cryopreserved Leukopaks collected from donors who meet FDA 21 CFR 1271 requirements only

GMP Cleanroom

All cryopreservation steps occur within the class ISO 7 cleanroom with grade A and B zones according to Master Batch Record.

  • Adjacently located to collection facility
  • Robust environmental monitoring
  • Step-down suites and one-way product flow
  • Cryogenic storage with continuous temperature monitoring and alarming
  • Dedicated controlled environment room operations, equipment management, and trained staff

Pre-Characterized Donor Selection Program

Discovery’s 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 our integrated analytical capabilities.

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