GMP CAR-T mRNA Manufacturing Service

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Creative Biolabs stands at the forefront of innovative cell and gene therapy solutions by providing global CDMO services for CAR-T therapy development. As part of our extensive suite of offerings, we specialize in in-vitro transcription (IVT) RNA services manufacturing to facilitate the production and scalability of CAR-T therapies. Our commitment to excellence and quality ensures that every stage of the CAR-T development process is meticulously managed to meet the unique needs of our clients.

GMP CAR-mRNA Manufacturing Platform

At Creative Biolabs, our expertise extends across various domains, and we are particularly proud to offer advanced IVT RNA services tailored to the specialized needs of CAR-T cell therapy. We have developed a Good Manufacturing Practice (GMP) mRNA manufacturing platform that is designed to provide high-quality CAR-mRNA. Our platform ensures that the production of mRNA is precise, scalable, and free from impurities, which are crucial for maintaining the safety and efficacy of the resulting CAR-T cells. The platform is optimized for both small-scale and large-scale production, which caters to different phases of CAR-T therapy development—from preclinical studies to clinical trials and commercialization. This flexibility allows for the efficient scale-up of mRNA production, ensuring a seamless transition through the various stages of therapy development.

Our Capabilities

Our comprehensive suite of analytical methods for plasmid, mRNA, and mRNA-LNP products ensures final product quality. We support your project from in-process controls and release testing through to stability studies, all tailored to your specific requirements.

Analysis and testing of GMP CAR-mRNA Manufacturing. (Creative Biolabs Original)

Manufacturing Steps

Our proprietary process combines precision engineering, traceable documentation, and automated control to deliver mRNA suitable for CAR-T applications and clinical translation.

Workflow of GMP CAR-mRNA Manufacturing. (Creative Biolabs Original)

Quality Control

Attribute	QC Test
Purity, Concentration, and Integrity Analysis	UV-Vis spectroscopy, agarose gel electrophoresis, capillary gel electrophoresis
mRNA Sequence Analysis	Sanger sequencing or next-generation sequencing (NGS)
Residual DNA Analysis	qPCR
Endotoxin Testing	KCA assay
Microbial Testing	Sterility testing, bioburden testing
Protein Contamination	Western Blot, ELISA
Capping and Poly A tail Analysis	LC-MS, capillary gel electrophoresis

One-stop IVT CAR-RNA and LNP Manufacturing Services

Creative Biolabs offers a comprehensive suite of CAR-IVT RNA and LNP manufacturing services designed to accelerate the development of CAR-T cell therapies. Our advanced GMP mRNA manufacturing platform and state-of-the-art facility ensure that we consistently deliver high-quality, scalable solutions that meet the rigorous demands of modern therapeutic development. Partner with us to leverage our expertise and drive your CAR-T projects toward successful clinical and commercial outcomes.

Advantages

Advanced GMP laboratory: Our cleanrooms are classified to meet stringent GMP standards, ensuring contamination-free environments for mRNA production.
Robust Quality Control Systems: We implement rigorous quality control measures at every stage of the manufacturing process to ensure the highest product quality and consistency.
Specialized Equipment: Our facility houses state-of-the-art equipment for mRNA synthesis, purification, and analytical testing.
Expert Team: Our team comprises seasoned scientists and biomanufacturing experts with deep expertise in RNA technologies and therapeutic development.

Production Scale & Flexibility

Creative Biolabs offers customizable scales to meet each stage of CAR-T program development.

Production Level	Typical Batch Yield	Intended Use
Research Grade	10 µg – 1 mg	Feasibility & screening studies
Preclinical Scale	1 – 100 mg	In-vivo / toxicity studies
GMP-like Scale	0.1 – 1 g	IND-enabling production
Full GMP Transition	> 1 g	Clinical trials / regulatory submission

Frequently Asked Questions

What is the difference between GMP-like and full GMP manufacturing?

GMP-like follows the same controlled environment, qualified personnel, and analytical testing as full GMP, but is intended for preclinical or IND-enabling studies. Full GMP adds regulatory audits, QP release, and documentation for clinical use.

Can I provide my own plasmid template?

Yes. Clients may supply verified plasmids, and we will perform sequence validation and process optimization for IVT.

What are the typical deliverables?

You will receive mRNA material, full analytical reports, CoA, batch record, and storage recommendations.

Is the product suitable for preclinical or IND studies?

Absolutely. Our GMP-like mRNA meets preclinical/IND readiness standards and can be directly scaled to full GMP.

Client Feedback

"Creative Biolabs delivered our CAR-T mRNA faster than expected, with exceptional purity and consistent quality. Their documentation made our IND package submission seamless." — B***C.

"We transitioned from GMP-like to full GMP with zero process changes. Highly recommend their technical team." — H**P.

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