IND Grade CAR-T Manufacturing Service

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 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.

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.

Technical and Facility Capabilities

We specialize in providing IND-grade manufacturing support for innovative anti-cancer cell therapies, spanning from initial material collection to the final infused cell product. Whether you are advancing an autologous or allogeneic therapy, we act as your trusted manufacturing partner — delivering flexible, scalable, and quality-driven services to help you progress into the clinical phase.

Key Advantages

• Modular Manufacturing Platform: Our standardized production lanes allow faster ramp-up and reduced variability across projects.
• Scalable from Clinic to Commercial: We support seamless transition from early clinical batches to higher-volume manufacturing, reducing the risk of technology transfer disruption.
• Dedicated Project Management: Each client benefits from a dedicated team managing communication, timelines, and transparency throughout the project life cycle.

Client Feedback

"Partnering with Creative Biolabs enabled us to move from starting material to first patient dose in record time. The project management team kept us fully informed, and the hand-off to clinical supply went smoothly." — Senior Director, Immuno-Oncology Biotech.

"Their flexible manufacturing platform allowed us to scale seamlessly from Phase I to Phase II without changing the contract manufacturer. That transition alone saved us months and significant cost." — Head of Cell Therapy Development.

"The technical expertise and quality-control support were outstanding. We felt confident submitting our IND knowing the manufacturing partner had deep experience and full analytical capabilities." — Chief Scientific Officer, Gene-Engineered Cell Therapy Company.

Frequently Asked Questions

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.