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GMP-like 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 specializes in the development and manufacturing of CAR-T cells. Recognizing the pivotal role of RNA in the realm of gene therapy and immunotherapy, we offer comprehensive in vitro transcription (IVT) RNA manufacturing services for CAR-T, enabling enhanced therapeutic efficacy and safety. Our expertly tailored services ensure the highest quality and efficacy, empowering our clients to pioneer groundbreaking therapeutic solutions.

GMP-like mRNA

GMP-like mRNA refers to mRNA that is produced following the guidelines and principles of GMP but may not fully comply with all GMP requirements. It is often used for research and preclinical purposes where full GMP compliance is not mandatory but high quality and safety standards must still be maintained. At Creative Biolabs, we offer GMP-like mRNA manufacturing tailored for CAR-T therapies. This service aligns with GMP standards, ensuring high quality and safety for mRNA products used in therapeutic applications.

Fig.1 Application of GMP-like mRNA. (Creative Biolabs original)

GMP-like mRNA Manufacturing Service

At Creative Biolabs, we have developed a state-of-the-art GMP-like mRNA manufacturing platform. Our platform integrates the latest advancements in mRNA synthesis, purification, and quality control to deliver mRNA products that meet stringent regulatory and clinical standards. By following GMP-like standards, we ensure every batch of mRNA is produced with consistency, purity, and stability, minimizing risks associated with batch-to-batch variabilities.

Our lab is equipped with world-class facilities dedicated to the manufacturing of mRNA and lipid nanoparticles (LNP) encapsulated formulations. Our facilities adhere to the highest standards of quality and compliance, ensuring that our production environments are contaminant-free and optimized for the highest efficiency.

Workflow

Our manufacturing process starts from plasmid DNA templates that are meticulously designed and validated. The IVT is carried out using T7 RNA polymerase-driven transcription systems, ensuring the synthesis of mRNA with high fidelity. Post-transcriptional modifications, including capping and polyadenylation, are performed to enhance the stability and translational efficiency of the mRNA. Each batch undergoes rigorous quality control testing, including purity assays, sequence verification, and functionality tests, all conforming to GMP-like standards. The platform is designed to be scalable, providing flexibility for various levels of production needs, whether for small-scale research or large-scale preclinical applications.

Fig.2 Workflow of GMP-like mRNA manufacturing. (Creative Biolabs original)

Features

  • High Purity: Ensures that the mRNA produced is free of contaminants and impurities that could affect its function or safety.
  • Consistency: Batch-to-batch consistency is maintained to ensure reliable results in repeated experiments.
  • Traceability: Detailed documentation and traceability of production processes and materials are maintained.
  • Safety: While not fully GMP-compliant, GMP-like mRNA still adheres to many safety and quality guidelines to ensure its safe use in non-clinical settings.

At Creative Biolabs, we are committed to advancing the development of CAR-T therapies with our robust and reliable mRNA and LNP manufacturing services. Partner with us to unlock the potential of your therapeutic innovations and make strides towards transformative healthcare solutions. Please contact us for your GMP-like CAR mRNA project.

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