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Human T Cell Leukopak Isolation Kit – GMP Grade

SKU:
13210-221GMP Categories: , , , ,

Isolate Healthier, More Viable Cells

The Human T Cell Leukopak Isolation Kit – GMP was developed with BACS™ Microbubbles to isolate untouched T cells from washed leukopak material via negative selection and is manufactured under stringent adherence to GMP requirements. Leveraging the gentleness of flotation, non-T cells are targeted and removed with antibodies. Negatively selected T cells are suitable for a wide variety of downstream assays, including cell culture, flow cytometry, scRNA-Seq, engineering, or other functional studies. The Human T Cell Leukopak Isolation Kit – GMP has the capacity to isolate T cells from an average half-leukopak (12.5 x 10⁹ total cells).

  • GMP compliance per 21 CFR 820, 211, 210 and 11
  • Leukopak to purified cells in less than one hour, no matter the cell input number
  • Higher recovery of healthier T cells to enhance CAR-T production
  • Reduce cell impurities and improve your  transduction efficiencies
  • Scale up to tens of billions of cells: compatible with the Alerion™ Microbubble Cell Separation System
  • Negative selection workflow eliminates concerns of particles directly bound to T cells
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Product Details

How it Works: The Human T Cell Leukopak Biotin Antibody Cocktail – GMP is added to the leukapheresis product to label unwanted cell populations. BACS™ Streptavidin Microbubbles – GMP are added to the sample and bind to the biotin-labeled cells. Due to their inherent buoyancy, the microbubbles quickly and gently float the non-T cells to the surface. Following centrifugation, the T cells in their original state are collected.

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Additional Information:

  • Compatible with the Alerion™ Microbubble Cell Separation System
  • Kit components sterilized by filtration or electron beam irradiation
  • Antibody Cocktail (biotinylated): CD14, CD16, CD19, CD20, CD36, CD56, CD123, CD235ab.
  • Storage: 4°C
  • Target Cell Type: T Cells
  • Sample Species and Source: Washed Human Leukopak
  • Cell Separation Method: Negative Selection
  • Capacity: 12.5 x 109 total cells

This Kit Comes With:

  • BACS™ Streptavidin Microbubbles – GMP
  • Human T Cell Leukopak Biotin Antibody Cocktail – GMP
  • Separation Buffer – GMP (Ca2+ and Mg2+ free PBS containing 2 mM EDTA, 0.5% biotin-free BSA)

View the Checklist for Using Akadeum Cell Therapy Kit Products

Key Features

Scalability

Go from research scale to commercialization scale with microbubbles. Just use more or less to suit your research needs.

Example of scale: 50 million cells in a tube, to 1 billion cells in bag, to 18 billion cells in a BioRise™ Consumable.

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Apheresis material was platelet washed using Thermo Fisher Scientific’s Rotea™ cell washing instrument and then isolated using Akadeum’s negative selection Human T Cell Leukopak Isolation Kit. Samples were processed either in a 50 mL tube at 500 million total starting cells or in a BioRise™ Consumable on the Alerion™ Microbubble Cell Separation System at 5-15 billion cells per consumable. These assays were performed in triplicate.

The Right Products to Support Your Pipeline

The Human T Cell Leukopak Isolation Kit -GMP is ideal for research through preclinical studies. A Clinical Ready version (ISO 20399 and ISO 10993 tested) will soon be available to support Phase I through commercialization of cell therapy workflows.

Manufacturing by a third party, FDA-registered facility is available, please contact us.

 

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Data

High Purity and Yield at Any Scale

Untouched T cells were isolated from platelet-washed leukopak material using the Human T Cell Leukopak Isolation Kit in accordance with the published protocol. Isolation was completed with either 100 million cells in a 5 mL tube or 1 billion cells in a 50 mL tube. Samples were run in triplicate. To determine T cell purity and yield, isolated T cells and an aliquot of the initial sample were labeled with CD45-FITC and CD3-APC Fire/750. The fluorescently labeled cells were analyzed by flow cytometry.  Dead cells and debris were excluded from the analysis.

t cell isolation process stats
yield t cell isolation stats

Resources

Protocol Sheet

View the Human T Cell Leukopak Isolation Kit - GMP Grade User Guide

For processing on the Alerion™, please refer to the:
AlerionTM Human T Cell Leukopak Isolation Kit - GMP User Guide

Application Notes

Lonza Integrates Akadeum's Human T Cell Isolation Kit - GMP on the Cocoon Platform
Unmatched Scalability, from Process Development to Manufacturing, Akadeum has your BACS

Publications & References

View the Human T Cell Leukopak Isolation Kit - GMP Grade Flyer

GMP Compliant BACS Microbubble Bag-Based T Cell Isolation in a Closed System CAR T Cell Manufacturing Workflow

Efficient and Reliable Cell Separation Using Microbubbles for CAR-T Cell Manufacturing

Akadeum Microbubbles: With You from Research to Commercialization

Regulatory

As a supplier of ancillary materials for cell and gene therapy, Akadeum recognizes the criticality of confidence in materials and is committed to developing products with appropriate quality efforts.

Our GMP Grade products are tested per USP <85> Endotoxins and USP <71> Sterility prior to release by certified third-party labs. Functional testing includes cell isolation.

GMP standard adherence includes:

  • 21 CFR 820
  • 21 CFR 210
  • 21 CFR 211
  • 21 CFR 11
  • ISO 11137
  • Use of USP Class VI plastics in production and bottling

in addition to related ICH standards.

 

Kit components are sterilized by filtration or electron beam irradiation.

Akadeum is compliant with ISO 11137: Sterilization of Health Care Products – Radiation (2024)

For more information on Quality at Akadeum, please visit https://www.akadeum.com/about/quality/

To request a GHS SDS or Certificate of Analysis, please contact us at info@akadeum.com

*Manual Clinical Ready Kits Available: Human T Cell Depletion, Human T Cell Selection, Activation, and Expansion; Human T Cell Leukopak Isolation – contact us for more information on availability.

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