The Human T Cell Selection, Activation and Expansion Kit – Clinical Ready (CR) was designed to gently isolate highly pure T cells and activate them for use in cell therapy workflows. The kit is manufactured under strict adherence to GMP guidelines and tested to accepted standards for Ancillary Materials in Cell and Gene Therapy, with requirements for safety met.
In this positive selection workflow, T cells are isolated, activated, and expanded using Akadeum’s Selection, Activation & Expansion Microbubbles – CR in combination with an antibody cocktail (CR) that targets CD3 and CD28. Highly scalable to support various cell input requirements for cell therapy, the workflow yields large numbers of activated and transducible cells needed in the manufacturing of T cell based therapies. The gentleness of flotation-based separation and activation results in fewer exhausted cells compared to legacy activation methods, enabling better therapies with healthier cells.
Ancillary Materials Standards Adherence: ISO 20399, ISO 10993, USP <1043>
GMP Compliance per 21 CFR 820, 211, 210 and 11
Greater activation and lower cellular exhaustion for healthier cells, enabling better therapies
Improved expansion of highly activated effector T cell populations.
Closed-system in-bag workflows available
Healthy cells in a fraction of the time enable improved production of therapeutic CAR-T cells. For meaningful outcomes.
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 targeting CD3 and CD28. BACS™ Selection, Activation & Expansion Microbubbles – CR 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.
Additional Information:
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.
Kit components sterilized by filtration or electron beam irradiation
Go from research scale to commercialization with microbubbles. Just use more or less to suit your research needs and keep performance maintained.
Alerion™ Microbubble Cell Separation System compatibility with clinical ready reagents coming in early 2025
The Right Products to Support Your Pipeline
The Human T Cell Selection, Activation and Expansion Kit – CR is ideal to support Phase I to commercialization of cell therapy workflows. Prior to Phase I, a GMP kit is available for process development and preclinical work.
Manufacturing by a third party, FDA-registered facility is available, please contact us.
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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 and regulatory efforts.
Clinical Ready
Clinical Ready kits undergo additional testing beyond the requirements of GMP.
Akadeum is compliant with following standards for the Human T Cell Selection Activation Expansion Kit-CR:
ISO 20399 – Biotechnology – Ancillary materials present during the production of cellular therapeutic products and gene therapy products
ISO 10993 – Biological Evaluation of Medical Devices
USP <1043> – Ancillary Materials in Cell, Gene and Tissue Engineered Products
ICH Q3D(R2) Guideline for Elemental Impurities
The Human T Cell Selection Activation Expansion Kit – CR has been tested per the following biocompatibility tests (as determined in Table A.1: Biocompatibility Evaluation Endpoints, FDA, SEP2023*), reviewed by a certified toxicologist and have met specifications:
Cytotoxicity
Intracutaneous Reactivity
Acute Systemic Toxicity (IV and IP)
Hemolysis
Sensitization
Material Mediated Pyrogenicity
Thrombogenicity (with magnetics predicate)
The Human T Cell Selection Activation Expansion Kit – CR contains serum free and virus free antibodies, tested per ICH guidelines.
*“Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” FDA Guidance, SEP2023
GMP Grade
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
Additional Regulatory Information
Kit components are sterilized by filtration or electron beam irradiation. Akadeum is compliant with ISO 11137: Sterilization of Health Care Products – Radiation (2024)
Manufacturing by a third party, FDA-registered facility is available, please contact us.
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