Building on mRNA's success against viral pathogens, Creative Biolabs' Immunotherapy related mRNA Development Service uses it as a transient blueprint for TAA/TSA, encoding antigens or immune modulators in situ to bypass traditional vaccine limits. The service delivers end-to-end solutions, including personalized neoantigen mRNA design, cytokine/mAb-encoding mRNA, and targeted LNP formulations. Backed by advanced nucleoside modification, IVT platforms, and in vivo T-cell validation, it ensures robust expression and maximum immune activation, accelerating preclinical progress while avoiding insertional mutagenesis risks.
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This platform acts as a flexible genetic template, utilizing the cell's own machinery to direct the in vivo production of immunologically relevant proteins or antigens. This mechanism allows for the robust and potent functional outcome necessary to elicit strong and specific anti-tumor immune responses, offering a non-integrating and highly scalable solution for cancer treatment.
The versatility of the mRNA platform at Creative Biolabs extends well beyond simple antigen presentation, enabling complex strategies for TME modulation:
Fig.1 mRNA regulates the tumor microenvironment in vivo by inducing the death of diseased cells, regulating tumor-associated dendritic cells, regulating inhibitory cells, regulating the cytokine environment, and generating tumor-specific T cells.1,3
The combination of our specialized engineering and the inherent features of the mRNA modality provides significant advantages for oncology:
The development process at Creative Biolabs is structured into clear, milestone-driven phases, ensuring accountability and measurable outcomes at every stage.
To initiate a project, clients typically provide:
Identify and prioritize Tumor-Specific Antigens (TSA), Tumor-Associated Antigens (TAA), or therapeutic protein sequences (Cytokine/mAb). Design and optimize the mRNA sequence (UTR modification, Codon optimization).
Synthesize the DNA template and perform large-scale in vitro transcription (IVT) using proprietary protocols, including 1-methylpseudouridine (m1Ψ) nucleoside modification and Anti-Reverse Cap Analogues (ARCA) capping.
Mandatory HPLC purification to remove residual double-stranded RNA (dsRNA) impurities, achieving the state of immunological silence.
Encapsulate the purified mRNA into optimized Lipid Nanoparticle (LNP) carriers. Engineer the LNP surface with targeting moieties (e.g., specific ligands) for preferential delivery to Antigen-Presenting Cells (APCs).
Conduct comprehensive in vitro and in vivo evaluation to assess T-cell activation, specific cytokine expression levels, and anti-tumor efficacy in relevant preclinical models.
Final Deliverables: Upon completion, you will receive a Certificate of Analysis (CoA) for mRNA Purity (>95%), a Comprehensive In Vivo Immunogenicity Report detailing T-cell activation and protein expression, and the Final LNP Formulation Protocol.
Estimated Timeframe: The typical timeframe for this service ranges from 12 to 20 weeks, depending on the complexity of the neoantigen identification and the scope of the in vivo efficacy studies.
Creative Biolabs delivers a full suite of customizable services designed to overcome the core technical hurdles in developing high-performance mRNA immunotherapy candidates. We combine proprietary methods with stringent quality standards to deliver potent, clinical-ready products.
Customized mRNA Construct Design
Sequence optimization (UTRs, Codons) for maximized protein translation efficiency, tailored to expression in specific cell lines or target tissues.
Advanced IVT Capabilities
High-yield, scalable in vitro transcription utilizing premium nucleoside modification (e.g., 1-methylpseudouridine) and capping technologies (e.g., ARCA) to boost stability and expression by reducing innate immune interference.
Clinical-Grade Purity
Mandatory HPLC purification to achieve Immunological Silence (dsRNA elimination), ensuring a non-immunogenic transcript that directs specific anti-tumor immunity rather than non-specific inflammation.
Precision LNP Engineering
Bespoke Lipid Nanoparticle (LNP) formulation services, including tailored lipid ratios and the incorporation of targeting moieties for cell-specific delivery (e.g., Antigen-Presenting Cells) and optimal biodistribution.
Therapeutic Payload Versatility
Custom development for diverse payloads, including personalized neoantigen vaccines, pro-inflammatory cytokines, and mRNA-encoded monoclonal antibodies (mAbs) for intricate TME modulation strategies.
Synergy-Ready Candidates
Strategic design of therapeutics to maximize synergistic effects when combined with Immune Checkpoint Inhibitors (ICIs), significantly enhancing anti-tumor efficacy.
End-to-End Validation
Comprehensive analytical and preclinical in vivo validation (immunogenicity, biodistribution, T-cell response) to generate the robust data required for critical regulatory milestones.
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Some studies have proposed the idea of constructing mRNAs containing SCL-12, anti-CD137, and anti-TGF-β to enhance the intratumoral immunotherapy effect of mRNAs. The results in the figure show the construction scheme. After obtaining the corresponding mRNA, it was transfected into different target cells to detect the expression effect of IL-12. The anti-TGF-β and anti-CD137 effects were detected by ELISA experiments and flow cytometry, and positive results were obtained.
Fig.2 Construct mRNA-encoded functional constructs containing the anti-TGF-β and anti-CD137 properties of SCL-12 and scFv, and detect their expression and functions.2,3
We address instability through two critical engineering steps. First, we use nucleoside modifications (like m1Ψ) during IVT to enhance stability and longevity. Second, we custom-engineer Lipid Nanoparticles (LNPs), which act as robust shields, protecting the mRNA from degradation and ensuring highly efficient delivery and release into the target cell's cytoplasm.
Immunological Silence is vital because unpurified mRNA impurities (dsRNA) can trigger a non-specific innate immune response (Type-I IFN) that actually suppresses the production of your therapeutic protein/antigen. Our rigorous HPLC purification removes these impurities, silencing the unwanted signal so the therapeutic signal (the encoded antigen) is translated with maximum potency to activate the desired, specific T-cell response.
Unlike generic carriers, our LNP optimization service customizes the cationic and helper lipid composition to influence biodistribution, preferentially directing the payload to lymphoid tissues. Furthermore, we can incorporate targeting moieties (ligands or antibodies) onto the LNP surface to achieve high-efficiency delivery to desired cell types, such as Dendritic Cells, significantly optimizing the vaccination process.
Absolutely. Our most advanced offerings are centered on ICI synergy. We design mRNA constructs that encode potent pro-inflammatory cytokines (like IL-12 or IL-15) which re-program the tumor microenvironment, effectively converting immune-exclusionary 'cold' tumors into 'hot,' immune-infiltrated tumors, maximizing their responsiveness to subsequent ICI treatment.
At Creative Biolabs, we transform the theoretical promise of mRNA into a potent, personalized, and manufacturable clinical reality. Our integrated platform, which includes In Silico Structure Prediction, IVT Optimization, HPLC purification for Immunological Silence, and Custom Delivery Vehicle Engineering, ensures every component of your therapeutic is engineered for success. We are your dedicated partner for accelerating lead candidates in precision oncology, especially those targeting TME modulation and ICI synergy.
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| Cat. No | Product Name | Promoter |
|---|---|---|
| GTVCR-WQ0010MR | IVTScrip™ pT7-VEE-mRNA-TGFB1 Vector | T7 |
| GTVCR-WQ12MR | IVTScrip™ pT7-VEE-mRNA-Anti-S, 2130 Vector | T7 |
| GTVCR-WQ13MR | IVTScrip™ pSP6-VEE-mRNA-Anti-S, 2130 Vector | SP6 |
| GTVCR-WQ15MR | IVTScrip™ pT7-VEE-mRNA-Anti-TNFRSF17, 2857916 Vector | T7 |
| GTVCR-WQ17MR | IVTScrip™ pSP6-VEE-mRNA-Anti-TNFRSF17, 2857916 Vector | SP6 |
| Cat. No | Product Name | Type |
|---|---|---|
| GTTS-WQ010MR | IVTScrip™ mRNA-β gal, 5-Methoxy-U modified (Cap 1, 30 nt-poly(A)) | Reporter |
| GTTS-WQ11MR | IVTScrip™ mRNA-Anti-S, 2130(Cap 0, N1-Methylpseudo-UTP, 120 nt-poly(A)) | Antibody |
| GTTS-WQ12MR | IVTScrip™ mRNA-Anti-S, 2130(Cap 1, N1-Methylpseudo-UTP, 120 nt-poly(A)) | Antibody |
| GTTS-WQ13MR | IVTScrip™ mRNA-Anti-S, 2130(Cap 0, N1-Methylpseudo-UTP, 30 nt-poly(A)) | Antibody |
| GTTS-WQ14MR | IVTScrip™ mRNA-Anti-S, 2130(Cap 1, N1-Methylpseudo-UTP, 30 nt-poly(A)) | Antibody |
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