Akadeum’s Human T Cell Depletion Kit – CR 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 workflow, unwanted T cells expressing CD3 are positively isolated using a cocktail of biotinylated anti-CD3 antibodies (CR), which are then captured using buoyant Human T Cell Depletion Microbubbles – CR that gently float the targeted cells to the top of the sample. This leaves a highly pure sample of engineered cells untouched and ready for downstream formulation. The highly scalable nature of this process means that it can easily be incorporated into a wide variety of cell therapy manufacturing workflows.
Ancillary Materials Standards Adherence: ISO 20399, ISO 10993, USP <1043>
GMP Compliance per 21 CFR 820, 211, 210 and 11
Highly pure CD3 negative cells post-depletion.
Increased recovery of gene-edited cells for downstream formulation.
Gentle process maintains the viability of the cell therapy product
Akadeum’s process offers an elegant solution for highly effective and scalable T cell depletion. Biotinylated anti-CD3 antibodies (CR) bind to untransduced T cells still expressing the CD3 epitope. Streptavidin coated Depletion Microbubbles – CR then selectively bind to the antibodies labeling the undesired cells. Due to inherent buoyancy, the microbubbles naturally float to the surface of the culture vessel bringing along CD3+ cells. The bubble-bound cells can then be easily extracted off the surface with the depletion microbubbles – CR, leaving untouched engineered cells.
Additional Information:
Storage: 4°C
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 coming in early 2025
The Right Products to Support Your Pipeline:
With the appropriate safety testing completed, the Human T Cell Depletion Kit – CR is ideal for Phase I to commercialization of cell therapy workflows. GMP and RUO kits are also available for earlier stages of cell therapy pipelines.
Manufacturing by a third party, FDA-registered facility is available, please contact us.
Resources
User Guide
Publications & References
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 Depletion 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 Depletion 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 Depletion 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
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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