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IND Grade CAR-T Manufacturing Service

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All products and services are For Research Use Only and CANNOT be used in the treatment or diagnosis of disease.

CAR-T Cell Mechanism

CAR-T cells are created by re-engineering an individual's T lymphocytes in the lab to express receptors that can recognize tumor antigens. Once these cells have been proliferated ex vivo, they are re-infused into the individual to identify and attack tumor cells.

Fig.1 The focus and objectives for innovating CAR-T cell engineering.Fig. 1 The various aspects of CAR-T cell design and development.1

When the CAR binds to an antigen on the surface of tumor cells, it activates the T cells, prompting them to proliferate and release cytokines, thereby enhancing the immune response. Activated CAR-T cells can directly kill tumor cells primarily by releasing cytotoxic molecules such as perforin and granzymes. The design of CAR-T cells aims to enhance their persistence and memory within the body, allowing for a rapid response in the event of tumor recurrence. Gene editing technologies are being utilized to modify CAR-T cells, enhancing their anti-tumor capabilities and their ability to withstand the tumor microenvironment. Next-generation CAR-T cells (such as fourth-generation CAR-T cells) are designed to secrete immune-modulating factors that improve their survival in the tumor microenvironment and counteract the immunosuppressive effects of tumors.

IND Grade CAR-T Manufacturing at Creative Biolabs

Creative Biolabs provides a comprehensive suite of services, beginning with the development of processes and test methods that are tailored to meet specific project needs while adhering to GMP standards. We offer flexible production scales and process designs for the manufacturing of CAR-T cells. We also ensure that our methods are validated by focusing on specificity, accuracy, precision, and other essential parameters. Additionally, we conduct stability studies that encompass long-term, accelerated, and shipping stability assessments.

1-1-27-7-2-ind-grade-car-t-manufacturing-service-2

By employing closed and automated cell culture equipment, Creative Biolabs aligns with global industry standards, ensuring efficiency and consistency. Our cell manufacturing facility is designed to achieve higher cell proliferation rates and effectively address challenges related to low positive rates. With extensive experience in manufacturing clinical samples and handling IND submissions, Creative Biolabs welcomes collaboration and invites you to reach out for partnership opportunities.

Frequently Asked Questions

Q1: What are the components of quality control in the context of CAR cell manufacturing?

A1: Quality control in CAR cell manufacturing includes routine tests such as appearance, pH, osmolality, cell counts, and cell viability. It also involves safety tests, which assess CAR gene copy number, endotoxin levels, sterility, and mycoplasma presence, as well as impurity assessments.

Q2: How does your team ensure the efficient progression of a client's project?

A2: Our team ensures the efficient progression of a client's project through expert project management, which involves handling intricate details and ensuring the timely and accurate completion of all stages. This approach reduces the burden on the client's internal team, allowing them to focus on other critical tasks.

Reference

  1. Huang, R., et al. "Recent advances in CAR-T cell engineering." Journal of hematology & oncology. 13.1 (2020): 86. Distributed under Open Access license CC BY 4.0, without modification.
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