mRNA vaccines have revolutionized vaccinology with their speed and versatility, but first-generation linear mRNA has instability and inefficiency issues. Creative Biolabs focuses on the next-generation saRNA platform and LNP delivery strategies, offering customized services for developing high-potency mRNA therapeutics for infectious diseases and oncology. Our services accelerate therapeutic development, provide high-potency mRNA, and streamline pre-clinical processes. We deliver end-to-end solutions, ensuring maximum potency and a rapid transition to the clinic.
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The fundamental mechanism involves delivering the mRNA payload, protected within a Lipid Nanoparticle (LNP), into a target cell.
Fig.1 The mechanism of action of mRNA vaccines.1,3
A successful mRNA vaccine requires optimization of three main components:
The combined potency of the mRNA platform provides specific, high-impact advantages for cancer immunotherapy:
Our process is designed for clarity, efficiency, and high-quality outcomes, ensuring full transparency at every stage. We establish a collaborative pipeline that is suitable for visualization as a high-precision flowchart, making every step clear to our potential clients.
To initiate a custom project and ensure optimal design, clients typically provide us with the following critical information:
We start with your antigen sequence and design the mRNA (linear or saRNA) construct. This includes meticulous codon optimization using proprietary algorithms and strategic nucleoside modification (e.g., pseudouridine) to balance stability, reduce innate immune sensing, and maximize translational efficiency.
Utilizing our large-scale in vitro transcription (IVT) capabilities, we synthesize the pure RNA payload. Rigorous multi-step purification and detailed QC checks (including integrity, purity via HPLC, and concentration) are performed to meet stringent standards.
This crucial step involves screening our library of proprietary ionizable lipids. We fine-tune the LNP composition to control size (Dynamic Light Scattering), PDI, and surface charge for enhanced stability, controlled tissue biodistribution, and superior endosomal escape.
We conduct comprehensive functional testing, beginning with in vitro gene expression or saRNA amplification kinetics. This is followed by critical in vivo immunogenicity studies (T-cell activation via ELISpot/Flow Cytometry and humoral response via ELISA/neutralization assays) in relevant animal models.
Upon successful pre-clinical results, our team provides consultation on transitioning the optimized formulation and synthesis protocol to larger scales, focusing on Quality-by-Design (QbD) principles.
As a biology expert, you understand that success in the mRNA space hinges on balancing potency, stability, and manufacturability. Creative Biolabs' Custom mRNA Vaccine Development Service offers end-to-end, fully customized solutions designed to de-risk your program and maximize therapeutic impact, particularly for complex oncology and chronic disease applications.
Proprietary Self-Amplifying RNA (saRNA) Platform
Access to our specialized Alphavirus replicon technology, which delivers exponential gene expression and dramatically reduces the required therapeutic dose, cutting costs and improving safety profiles.
Customized LNP Formulation and Screening
Dedicated Lipid Nanoparticle (LNP) optimization to achieve ideal size, PDI, and surface characteristics for targeted delivery and superior endosomal escape in extra-hepatic tissues.
Precision RNA Stabilization & Optimization
Advanced services including proprietary codon optimization algorithms and strategic nucleoside modification to ensure high fidelity replication and maximum translational efficiency, even for large saRNA constructs.
Comprehensive Pre-Clinical Data Package
Provision of a full suite of in vitro QC and in vivo immunogenicity data, including T-cell profiling and functional efficacy studies, critical for smooth transition into clinical development.
One-Stop Regulatory Support
Our well-established quality system and robust documentation procedures support your efforts toward regulatory submission, ensuring quality assurance from sequence design through final product analysis.
Immune checkpoint inhibitors (ICIs) can only significantly improve the survival period of a small number of patients. The reason for this poor therapeutic effect lies in the immunosuppressive properties of the tumor microenvironment (TME). Some studies have shown that systemic injection of highly immunogenic mRNA nanoparticles can induce cytokine/chemokine responses similar to viremia, thereby resetting the immune microenvironment throughout the body and within tumors, and making drug-resistant tumors sensitive to ICIs again. By constructing the COVID-19 mRNA vaccine, the expression of PD-L1 in the tumor cells of patients vaccinated with the COVID-19 mRNA vaccine will be higher. The average TPS value of PD-L1 in patients who had received the COVID-19 mRNA vaccine within 100 days before biopsy was 24% higher than that in patients who had not received the COVID-19 mRNA vaccine before biopsy. Moreover, mRNA vaccines targeting non-tumor-associated antigens can stimulate a strong anti-tumor immune response, thereby making tumors more sensitive to immune checkpoint inhibitors (ICI).
Fig.2. The clinical outcomes of mRNA vaccines in increasing PD-L1 expression on tumors and improving the histology of various tumors.2,3
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Our solution is two-fold: First, we use Self-Amplifying RNA (saRNA), which exponentially replicates itself inside the cell, ensuring sustained expression long after the initial dose. Second, we apply strategic Nucleoside Modification and use custom-optimized LNPs to protect the RNA payload from degradation, guaranteeing the template remains viable until endosomal escape.
The saRNA platform is highly versatile. Its core advantage—sustained, high-level protein production—makes it ideal for Protein Replacement Therapy (e.g., genetic disorders). By requiring far fewer doses than linear mRNA, it significantly improves patient compliance and reduces the frequency of administration.
Yes, LNP customization is a cornerstone of our service. We do not use generic formulations. We screen and optimize the composition of the ionizable and helper lipids to achieve the necessary biophysical characteristics (size and charge) for Targeted Delivery and enhanced tropism to specific extra-hepatic tissues, such as the spleen, for potent immune activation.
We implement a rigorous Quality-by-Design (QbD) approach. Every batch undergoes comprehensive analytical testing, including HPLC for RNA purity, DLS/PDI for LNP size and uniformity, and encapsulation efficiency checks. Our detailed Final Analytical Data Package ensures transparency and regulatory readiness for your pre-clinical submission.
The primary advantage is Potency and Durability. While linear mRNA provides a burst, our saRNA ensures sustained T-cell immunity, which is critical for clearing solid tumors and overcoming the immunosuppressive microenvironment. Furthermore, the inherent adjuvant effect, combined with our Customized Neoantigen Payload integration, maximizes the therapeutic index.
Creative Biolabs is your specialized partner for accelerating next-generation therapeutics. By leveraging our expertise in Self-Amplifying RNA (saRNA) design, proprietary LNP delivery optimization, and a workflow grounded in peer-reviewed scientific breakthroughs, we solve the critical challenges of dose, durability, and efficacy for your most ambitious programs. Let us help you transition from concept to clinic with confidence and speed.
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| Cat. No | Product Name | Promoter |
|---|---|---|
| GTVCR-WQ49MR | IVTScrip™ pSP6-VEE-mRNA-Anti-B4GALNT1, 14.18 mAb Vector | SP6 |
| GTVCR-WQ52MR | IVTScrip™ pT7-VEE-mRNA-Anti-EPCAM, 17-1A Vector | T7 |
| GTVCR-WQ53MR | IVTScrip™ pSP6-VEE-mRNA-Anti-EPCAM, 17-1A Vector | SP6 |
| GTVCR-WQ55MR | IVTScrip™ pT7-VEE-mRNA-Anti-CD37, 177lu-DOTA-HH1 Vector | T7 |
| GTVCR-WQ57MR | IVTScrip™ pSP6-VEE-mRNA-Anti-CD37, 177lu-DOTA-HH1 Vector | SP6 |
| Cat. No | Product Name | Type |
|---|---|---|
| GTTS-WQ30MR | IVTScrip™ mRNA-Anti-S, 2130(Cap 1, 2-Thio-UTP, 30 nt-poly(A)) | Antibody |
| GTTS-WQ31MR | IVTScrip™ mRNA-Anti-S, 2130(Cap 0, 5-Methyl-CTP, 120 nt-poly(A)) | Antibody |
| GTTS-WQ32MR | IVTScrip™ mRNA-Anti-S, 2130(Cap 1, 5-Methyl-CTP, 120 nt-poly(A)) | Antibody |
| GTTS-WQ33MR | IVTScrip™ mRNA-Anti-S, 2130(Cap 0, 5-Methyl-CTP, 30 nt-poly(A)) | Antibody |
| GTTS-WQ34MR | IVTScrip™ mRNA-Anti-S, 2130(Cap 1, 5-Methyl-CTP, 30 nt-poly(A)) | Antibody |
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