FIH CAR-T Manufacturing Service

Chimeric Antigen Receptor (CAR) T cells are genetically engineered cells designed to recognize and attack cancer cells. Recent innovations in the design of various components of CAR structures, including the extracellular domain, transmembrane domain, and intracellular domain, have enhanced the efficacy and persistence of CAR-T cells. At the same time, researchers are exploring multiple target antigens to improve treatment outcomes and have proposed strategies involving dual-target or combination-target CAR-T cells to reduce the risk of relapse due to antigen escape. With advancements in manufacturing technologies and deeper research into CAR-T cells, there is potential for more efficient, safer, and cost-effective CAR-T cell therapies.

Creative Biolabs is at the forefront of providing integrated Contract Development and Manufacturing Organization (CDMO) services for CAR-T therapy, specifically tailored for First-in-Human Grade (FIH).

Comprehensive CDMO Services

Our FIH-grade CAR-T manufacturing services encompass a wide array of offerings designed to meet the diverse needs of our clients. Creative Biolabs offers a comprehensive range of CDMO services for CAR-T cells, leveraging our technology platform to provide high-quality, customized solutions throughout the process. Our services include dossier preparation for ethical and regulatory approvals, tailored process development and validation, and robust quality control measures. We ensure the production of CAR-T cells in a GMP-like environment, with scalable manufacturing capabilities. Additionally, we focus on maintaining storage and shipping stability according to specific project requirements, all while utilizing advanced automated culturing equipment to enhance cell proliferation and meet clinical standards. With extensive experience in manufacturing and supporting IND submissions, Creative Biolabs is committed to advancing cellular therapy products effectively and efficiently.

Our Capabilities

We provide a comprehensive and adaptable manufacturing platform designed to meet the unique requirements of FIH-grade CAR-T development.

• Modular system adaptable to various CAR targets and vectors.
• Configurable batch size for pilot or multi-site studies.
• Data-driven process optimization and digital batch records.
• Technology-transfer capability for external GMP partners.

FIH-grade CAR-T Manufacturing at Creative Biolabs

Our services offer several significant advantages:

• Cryopreserved Cell Preparation: Our independently developed methods ensure high-quality cell preparation.
• Automated Culturing Equipment: We employ closed and automated systems that align with global industry standards, enhancing efficiency and consistency.
• GMP Compliance: Our facilities adhere to stringent clinical and commercial requirements, ensuring high-quality production.
• Improved Cell Proliferation: Our processes effectively address challenges related to low positive rates and proliferation rates.
• Safety and Efficacy: Creative Biolabs implements a comprehensive set of quality control measures for CAR-T cells to ensure safety and efficacy throughout the manufacturing process.
• Smoothness and Effectiveness: Creative Biolabs focuses on ensuring the smooth and effective execution of GMP projects through a dedicated team.

FAQs

Customer Reviews

"Creative Biolabs has been an outstanding partner for our FIH program. Their team ensured consistency across multiple production runs and helped us meet all documentation needs for our ethics submission."— Principal Investigator, A**C.

"Professional communication, timely delivery, and reliable cell performance — the best experience we’ve had with an external manufacturing partner."— Biotech Project Manager, D**B.

"Their CAR-T manufacturing service gave us reproducible results that directly supported our preclinical publications."— Research Scientist, T**G.

Partner with Creative Biolabs

Partner with Creative Biolabs to accelerate your FIH-grade CAR-T development with trusted technical expertise and end-to-end support. Our dedicated team provides full transparency and scientific precision throughout manufacturing, ensuring your project achieves reliable and reproducible outcomes.

In recent years, CAR manufacturing technology has focused not only on reducing production time and improving cell quality but also on employing new technologies and gene editing techniques to enhance the anti-tumor capabilities and longevity of CAR-T cells. Creative Biolabs aims to adhere to established standards and requirements, facilitating the successful implementation of each project. We are looking forward to cooperating with you. Please contact us.