Creative Biolabs' One-Stop mRNA Therapeutic Development Services integrate molecular design and non-viral delivery (including LNP technology) to enable rapid in vivo therapeutic protein production. The service covers key development steps from sequence to IND-enabling data, delivering stable, highly expressed, non-immunogenic constructs. Backed by decades of expertise and advanced engineering platforms, we provide deliverables-based solutions to de-risk programs, address efficacy and targeted delivery challenges, and accelerate pipelines to clinical trials.
Fig.1 The mechanism by which mRNA induces immune responses and eliminates tumor cells.1
Our fully integrated platform covers every critical phase of mRNA therapeutic development:
| Immunotherapy related mRNA Development | Genetic Disease related mRNA Development |
| Design highly potent mRNA for therapeutic vaccines and in vivo cell reprogramming (e.g., Dendritic Cell, T Cell). Optimize antigen-encoding sequences to boost MHC Class I/II presentation, drive durable immunity, and support personalized cancer neoantigen vaccines and infectious disease prophylaxis. Deliver constructs for rapid, high-level antigen expression in target immune cells. | Develop stable, long-acting mRNA for protein replacement to address metabolic/genetic deficiencies. Use specialized modification and UTR optimization to extend translational half-life, enabling transient, non-integrating correction for enzyme deficiency or structural protein missing diseases, and assist in designing repeat dosing protocols. |
| Protein Replacement Therapy related mRNA Development | Regenerative Medicine related mRNA Development |
| Create specialized, high-yield mRNA constructs for systemic delivery and sustained dosing. Focus on systemic diseases (e.g., blood factors, hormones) requiring high concentration and continuous availability. Engineer constructs with minimal innate immune activation to enable safe, frequent re-administration for chronic management. | Use non-integrating mRNA for iPS Cell Reprogramming and localized tissue repair. Leverage mRNA's non-integrating feature (safer than viral vectors) for transient transcription factor expression (e.g., Yamanaka factors) without genomic disruption. Customize delivery systems for localized use in cardiac muscle or chronic wound regeneration. |
| Therapeutic Antibody-coding mRNA Development | mRNA Pharmacology Optimization |
| Encode complex therapeutic antibodies (full-length IgGs, Fab fragments, multi-specific formats) for in vivo transient, high-titer production. Offer a rapid, scalable alternative to traditional mAb manufacturing, enabling high local concentration at administration sites and simplifying manufacturing logistics/cost. | Use In Silico Structure Prediction and in vivo biodistribution studies to optimize dosing, administration route, and expression kinetics. Predict mRNA secondary structures, optimize GC content for stability and ribosomal binding, and fine-tune LNP composition via biodistribution tracking to minimize off-target expression and maximize therapeutic index. |
| mRNA Vaccine Development | |
| Provide full-service development (construct design, modification, formulation, immunogenicity evaluation) for prophylactic/therapeutic vaccines. Support from identifying immunogenic epitope sequences to conducting pre-clinical immune monitoring (e.g., ELISPOT, flow cytometry), ensuring efficacy for infectious disease prevention and potent cellular destruction for cancer treatment. |
We employ a systematic, stage-gated workflow designed for maximum efficiency and robust data generation, ensuring clear decision points for potential clients.
Target protein sequence (cDNA or amino acid) is needed to initiate in silico design. Desired tissue tropism or target cell information guides the selection of appropriate LNP or polymer vehicles. Preliminary vector design or cell line information (if available) helps optimize context-specific construct elements.
Involves sequence analysis, UTR/ORF optimization, and critical immunogenicity profiling. The outcome is an optimized mRNA sequence and construct plan.
Includes IVT production, purification, and critical nucleoside/cap analog modification (e.g., Pseudouridine, ARCA). The outcome is a highly stable, non-immunogenic mRNA drug substance.
Encompasses custom LNP/Polyplex formulation, along with critical particle size and zeta potential characterization. The outcome is a target-specific, clinically relevant non-viral delivery vehicle.
Involves in vitro expression assays, serum half-life testing, and endosomal escape efficiency verification. The outcome is a validated lead formulation and dose range.
Includes preliminary in vivo biodistribution studies and immunogenicity analysis. The outcome is an optimized dosing and administration strategy for IND-enabling studies.
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As your specialized partner, Creative Biolabs delivers more than just synthesis; we provide a fully integrated, customizable scientific roadmap to de-risk your mRNA therapeutic program and position you for clinical success.
Customized Molecular Engineering for Maximum Yield
Proprietary nucleoside modification platforms (e.g., Pseudouridine, 5-Methylcytidine) combined with advanced In Silico optimization to deliver constructs with up to 45% higher protein expression and lowest possible immunogenicity.
Precision Non-Viral Delivery Mastery
Expertise in engineering customized Ionizable Lipids and Hybrid Lipopolyplex Systems specifically tailored to overcome the challenging endosomal escape barrier and achieve targeted tissue tropism (e.g., non-hepatic, CNS, or muscle tissue).
Integrated, End-to-End Program Acceleration
We offer a seamless, single-vendor workflow from sequence design to clinically-relevant, pre-clinical validation, drastically reducing your time to lead candidate selection by up to 30%.
Scalable and Regulatory-Ready Data
All our synthesis and formulation processes are geared toward generating cGMP-compliant data and comprehensive documentation, providing direct, high-quality support for the Chemistry, Manufacturing, and Controls (CMC) section of your regulatory filings.
Specialized Therapeutic Focus
Dedicated platforms and expertise for complex areas including saRNA development, in vivo cell reprogramming (Dendritic Cells, T Cells), and the development of complex Therapeutic Antibody-coding mRNA.
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Our proprietary modification strategy (e.g., using Pseudouridine) specifically mutes recognition by innate immune receptors (TLRs). This minimizes pro-inflammatory cytokine release, thereby reducing the risk of systemic adverse events observed with unoptimized IVT transcripts—a critical aspect we customize for every project.
Commercial reagents offer general delivery, but custom LNPs, which we formulate with precision-engineered ionizable lipids, are optimized for stability, endosomal escape, and, most importantly, specific tissue tropism to maximize efficacy at your target site (e.g., CNS or muscle). If you have a non-hepatic target, a custom formulation is essential.
Yes, our platform is fully equipped for both conventional mRNA and saRNA. We offer specific optimization and stability evaluation assays tailored to the replication mechanism of saRNA to ensure maximum amplification and prolonged protein expression without compromising safety or purity.
Our deliverables include comprehensive documentation, cGMP-ready data, and detailed batch records on formulation and QC. This significantly streamlines the preparation of the Chemistry, Manufacturing, and Controls (CMC) section of your IND application, accelerating your regulatory timeline.
We can often diagnose low-expression issues within 2-4 weeks using our In Silico Optimization and rapid mRNA Stability Evaluation assays. By identifying bottlenecks in UTR, ORF, or capping efficiency, we provide an accelerated, data-driven path to a high-expressing lead construct.
Creative Biolabs offers the industry's most comprehensive One-Stop mRNA Therapeutic Development Services, giving you a strategic advantage in the race toward clinical success. Our platform ensures mastery over the two critical hurdles: superior construct engineering and targeted non-viral delivery.
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