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Akadeum Selection Activation and Expansion Kit

Akadeum Selection Activation and Expansion Kit GMP

Human T Cell Selection, Activation, and Expansion Kit – GMP Grade

SKU:
13310-224GMP800 Categories: T Cell Isolation Products, Cell Therapy, Activation & Expansion Products, Immunology

Less Exhausted Cells for Better Therapies

The Human T Cell Selection, Activation and Expansion Kit – GMP was designed to gently isolate highly pure T cells and activate them for use in cell therapy workflows and is manufactured under stringent adherence to GMP requirements. In this positive selection workflow, T cells are isolated, activated, and expanded using Akadeum’s Selection, Activation & Expansion Microbubbles – GMP, in combination with a GMP antibody cocktail that targets CD3 and CD28. Highly scalable, this process yields large numbers of activated and transducible cells needed for process development and preclinical research of T cell based therapies. The gentleness of flotation-based separation and activation results in fewer exhausted cells compared to legacy activation methods, leading to better T cells and improved cell therapy workflows.

GMP Compliance per 21 CFR 820, 211, 210 and 11
Sterile, low endotoxin kit components per USP guidelines
Greater activation and lower cellular exhaustion for healthier cells, enabling better therapies
Improved expansion of highly activated effector T cell populations.
Scalable: process billions of cells with the Alerion™ Microbubble Cell Separation System
Closed-system in-bag workflows available
Clinical Ready Grade available to support clinical trials through commercialization of your cell therapy pipeline

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Product Details

How it Works:

Akadeum’s novel approach to positive selection for CAR-T cell production provides improvements over current industry standard methods, and the innate scalability of BACS™ microbubbles allows for rapid optimization of cell therapy workflows.

Using washed leukopak material or PBMCs as a starting material, T cells are labeled with biotinylated antibodies (GMP grade) targeting CD3 and CD28. BACS™ Selection, Activation & Expansion Microbubbles – GMP are mixed into the sample where they bind to the labeled cells and gently float them to the surface. Unwanted cells can be removed from below the microbubble layer, and the positively selected T cells transferred to a culture vessel.

BACS™ are inherently inert and do not impact culture conditions. Over time and with cell division, cells gently settle to the bottom of the plate where they continue to expand until collection.

selection activation expansion workflow

Additional Information:

Compatible with the Alerion™ Microbubble Cell Separation System
Kit components sterilized by filtration or electron beam irradiation
Antibody Cocktail (biotinylated, GMP): CD3 and CD28
Storage: 4°C
Cell Type: T Cells
Sample Species and Source: Human PBMC or platelet washed Leukopak material
Cell Separation Method: Positive Selection
Capacity: 800 x 10⁶ nucleated cells

This Kit Comes With:

Selection, Activation & Expansion Microbubbles – GMP
Selection Activation & Expansion Antibody Cocktail – GMP

View the Checklist for Using Akadeum Cell Therapy Kit Products

Key Features

Scalability

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

Human T Cell Leukopak Isolation Kit, human t cell leukopak, human t cell leukopak isolation, human t cell leukopak, human t cell leukopak separation, human t cell leukopak isolation product

The Right Products to Support Your Timeline

The Human T Cell Selection, Activation and Expansion Kit – GMP is ideal for process development through preclinical stages, with the Clinical Ready version available to support Phase I to commercialization of cell therapy workflows.

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

Resources

User Guide

For processing on the Alerion™ Microbubble Cell Separation System, please refer to:

App Notes

Publications & References

Video

Follow along with our expert-in-residence, Jason Ellis, PhD, as he demonstrates the protocol with PBMCs and apheresis materials.

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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