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GMP CAR-T mRNA 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.

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.

Workflow

Our GMP mRNA manufacturing process includes several key steps:

  • Template Preparation: We utilize high-fidelity DNA templates to ensure accurate transcription of mRNA.
  • In Vitro Transcription: Our optimized IVT protocols maximize yield and purity, producing mRNA with minimal impurities.
  • Post-transcriptional Modifications: We employ advanced capping strategies and polyadenylation to enhance mRNA stability and translation efficiency.
  • Purification: Using cutting-edge chromatographic techniques, we ensure the removal of any residual contaminants.

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.
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