Research Grade (RG) CAR-T mRNA Manufacturing Service

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CAR-T therapy has emerged as a groundbreaking approach in the immunotherapy landscape. Given the complexity and specificity of CAR-T therapy, the production of high-quality materials such as in vitro transcribed RNA (IVT RNA) is crucial. IVT RNA plays an essential role in delivering genetic information into T cells, facilitating the expression of CARs. At Creative Biolabs, we are committed to providing top-tier IVT RNA manufacturing services specifically optimized for CAR-T applications. Our advanced platform ensures precision and efficiency, supporting researchers and clinicians in the development and deployment of cutting-edge CAR-T therapies.

RG mRNA Manufacturing Service

At Creative Biolabs, our IVT RNA platform is meticulously designed to meet the diverse needs of researchers and clinicians in developing of CAR-T therapy. This platform integrates state-of-the-art technologies and stringent quality control measures to ensure the production of high-fidelity mRNA transcripts, which are crucial for effective CAR-T cell engineering. Utilizing a comprehensive IVT RNA platform, our experts proudly provide high-quality mRNA tailored for research purposes, ensuring that the initial stages of CAR-T and other advanced therapies are founded on reliable and effective mRNA constructs. By employing our RG mRNA manufacturing platform, researchers can confidently advance their CAR-T studies, armed with the assurance that their mRNA constructs are of the highest quality.

One-stop IVT RNA and LNP Manufacturing

Fig.1 Our services. (Creative Biolabs original)

Our Capabilities

At Creative Biolabs, we provide an integrated mRNA manufacturing platform specifically optimized for CAR-T and other cell-based immunotherapies. Our advanced capabilities cover every stage of mRNA production - from DNA template design to purified, translation-ready mRNA - ensuring high yield, reproducibility, and regulatory compliance.

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

Quality Assurance

To guarantee the integrity, reproducibility, and safety of our research-grade CAR-T mRNA products, Creative Biolabs performs a full panel of in-process controls and release tests. Each mRNA batch undergoes strict analytical validation to ensure compliance with the key quality attributes required for advanced cell therapy applications.

Category Purpose Test Item
Identity Confirms correct mRNA construct and sequence fidelity mRNA length verification (Agarose gel electrophoresis / Capillary electrophoresis)
Sequence confirmation (NGS or Sanger sequencing)
Integrity Ensures full-length mRNA without degradation RNA integrity number analysis
Capillary electrophoresis profile
Purity Confirms removal of impurities and template DNA HPLC / UV-spectrophotometry (A260 / A280 ratio)
dsRNA contamination assay (dot-blot or ELISA)
Residual DNA / protein quantification (qPCR / BCA assay)
Potency / Functionality Verifies that the mRNA produces a functional protein in target cells In-vitro translation assay
Cell transfection efficacy (flow cytometry or fluorescence readout)
Safety Ensures product is non-pyrogenic and microbe-free Endotoxin level (LAL test, ≤ 0.25 EU/µg)
Bioburden test (USP <61>)
Residual Impurities Confirms removal of process-related materials Enzyme residuals (T7 polymerase ELISA)
NTP residual assay

Frequently Asked Questions

Why should I choose the mRNA platform over established lentiviral vectors for my early-stage CAR-T research?

mRNA offers rapid, cost-effective production and, critically, transient expression, which provides an intrinsic safety switch for managing early toxicity. Furthermore, our non-viral method eliminates the risk of insertional mutagenesis associated with integrating vectors, streamlining your regulatory de-risking process.

How scalable is Research Grade mRNA production, and what is the path to GMP manufacturing?

Our RG platform is inherently scalable, moving easily from milligram-scale for early research to multi-gram quantities required for clinical development. The core synthesis and purification processes utilized in our RG service are designed to be compatible with our GMP manufacturing protocols, ensuring a smooth, low-risk technology transfer when you are ready to advance to clinical trials.

What measures does Creative Biolabs take to address the concern of mRNA immunogenicity?

Immunogenicity is primarily driven by double-stranded RNA (dsRNA) contaminants. We employ advanced multi-step purification techniques, including HPLC and TFF, to ensure the final mRNA product achieves exceptional purity, significantly minimizing dsRNA levels and ensuring a low innate immune response in your sensitive cell cultures.

Customer Reviews

Using Creative Biolabs' Research Grade (RG) CAR-T mRNA Manufacturing Service in our preclinical safety assays has significantly reduced off-target cytokine release. The removal of dsRNA contaminants was clearly superior to our in-house IVT methods, resulting in cleaner T cell profiles and more reliable in vivo data. Dr. La FD.

The transient nature of the CAR-T mRNA facilitated toxicity modeling in our solid tumor program. We could precisely control the duration of CAR expression, which was invaluable for establishing a crucial safety window and allowed us to mitigate potential CRS risks before moving to stable transduction methods. Jas Rz.

Highlights

  • Custom Design and Synthesis: We offer bespoke mRNA synthesis services that accommodate unique research needs, from gene sequence design to the final RNA product. Our clients can specify gene sequence design, choice of capping methods, and customizable poly(A) tail length to optimize the performance of their RNA.
  • High Purity and Yield: Our process ensures high yields of mRNA with exceptional purity, minimizing contaminants that could potentially interfere with downstream applications.
  • Scalability: Whether you require small-scale mRNA for preliminary testing or larger batches for extensive research, our platform is equipped to scale production accordingly.
  • Comprehensive Quality Control: Each batch of mRNA undergoes rigorous testing to verify its integrity, including sequencing and in vitro translation assessments, guaranteeing that you receive a product that performs reliably in your experiments.

Working with Creative Biolabs

At Creative Biolabs, we are committed to advancing the field of CAR-T therapy through our specialized IVT RNA and LNP manufacturing services. Our robust RG mRNA manufacturing platform combines scalability, high purity, customization, advanced quality control, and efficient delivery systems to meet the diverse needs of CAR-T researchers. By partnering with us, you gain access to cutting-edge technologies and expert support, empowering you to drive innovation and make significant strides in the fight against cancer.

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

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