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Custom mRNA Delivery Vehicle Development Services

Introduction mRNA Delivery Vehicle Workflow What We Can Offer FAQ

Introduction

mRNA therapeutics expand beyond vaccines to oncology/genetic diseases, but delivery (protecting mRNA, enabling cytoplasmic entry) is key—non-viral nanoplatforms like LNPs/polymers tackle this.

Creative Biolabs offers custom mRNA delivery services via lipid engineering, polymer chemistry, and eVLP design. We tailor high-performance nanosystems to your mRNA payload, ensuring safety, stability, and efficacy to boost clinical viability.

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Custom mRNA Delivery Vehicle Development Services

Creative Biolabs offers four core development platforms, ensuring a solution perfectly matched to your biological and therapeutic requirements.

The main delivery methods of mRNA include lipid nanoparticles, protein nanoparticles, polymer nanoparticles, viral itch particles, etc. (OA Literature)Fig.1 The main mRNA delivery platform based on nanoparticles.1

Lipid-based Vector Development

Lipid-based vectors, including Lipoplexes and next-generation Lipid Nanoparticles (LNPs), are the industry standard due to their exceptional ability to encapsulate mRNA and facilitate endosomal escape, primarily through the use of ionizable lipids. We customize the lipid component ratio, optimizing head-group chemistry and tail length based on the size (e.g., for standard mRNA versus larger saRNA) and chemical modifications of your transcript.

Polymer-based Vector Development

Polymer-based systems, such as Polyplexes and Micelleplexes, offer superior chemical tunability. We utilize various biocompatible polymers to create stable nanoparticles that can be precisely tailored for controlled release kinetics and specific surface functionalization. This approach is ideal for applications demanding high stability and the integration of specific targeting ligands for improved delivery specificity.

Hybrid Vector Development

The Hybrid Vector platform combines the best features of lipids and polymers, resulting in complex structures like Lipopolyplexes and Cationic Nanoemulsions. These systems are designed to maximize both stability (often provided by a polymeric core) and highly efficient cellular entry (via a lipid or lipid-like shell). Hybrid vectors are essential for complex applications that require simultaneous optimization of multiple physicochemical properties.

eVLP Development

Enveloped Virus-Like Particles (eVLPs) are advanced, non-replicating scaffolds that naturally mimic the fusogenic properties of viruses (e.g., LVLPs, VEEVLPs). They offer a highly efficient, biomimetic pathway for delivery into difficult-to-transfect cell types, yielding potent in vivo results, particularly for high-immunogenicity vaccines where the structural components can act as intrinsic adjuvants.

Characterization

Rigorous characterization is integral to our service. We provide a detailed analysis of Lipid Nanoparticle-formulated Drug Characterization, including size, PDI, Zeta Potential, and encapsulation efficiency, ensuring that the final optimized vector meets all quality control specifications necessary for preclinical success.

Workflow

Our structured, multi-stage workflow provides clarity and efficiency, ensuring that the final delivery system is fully customized and optimized for your unique payload.

Required Starting Materials

To initiate the bespoke design process, clients typically provide:

  1. mRNA Transcript Details: The specific sequence, modifications (e.g., Pseudouridine), and structural information (e.g., size for saRNA, 5' Capping status).
  2. Target Application and Cell Type: The intended therapeutic use (e.g., cancer vaccine, genetic disease) and the target cells (in vivo or ex vivo, e.g., DCs, hepatocytes).
  3. Desired Pharmacological Profile: Key metrics such as required duration of expression, target LD50 (toxicity threshold), and preferred route of administration.
Consultation & Design
Sequence Optimization

Design & Component Selection

Leverage computational modeling to select optimal lipid/polymer ratios and targeting moieties based on payload and target cell traits, delivering an initial vector architecture, optimized parameters (e.g., N:P ratio), and ready-to-synthesize raw materials.

Vector Synthesis & Formulation

  • Precisely synthesize custom components (e.g., ionizable lipids) and formulate via advanced techniques (microfluidics, ethanol injection), yielding crude batches for preliminary quality control and stability testing.
Chemical Modifications
Synthesis & Purification

Physicochemical Characterization

  • Analyze key metrics (particle size, PDI, Zeta Potential, encapsulation efficiency) to refine formulations, ensuring stability and uniform size (e.g., PDI <0.2).

In Vitro Efficacy & Toxicity

  • Test candidates on relevant cell lines for uptake, endosomal escape, protein expression (e.g., Luciferase assay), and cytotoxicity, selecting 2-3 leads with superior expression-to-toxicity ratios.
Quality Control & Validation
Delivery & Support

In Vivo Pilot & Finalization

  • Administer leads in animal models to assess biodistribution, PK, and preliminary PD, resulting in an optimized vehicle ready for scale-up and IND-enabling studies.

Final Deliverables

Upon project completion, clients receive specific documentation and materials:

  1. Comprehensive Formulation Report: Detailed synthesis protocols, component chemical characterization, and optimized manufacturing parameters.
  2. QC & Efficacy Data Package: Raw data and analysis for PDI, Zeta Potential, Encapsulation Efficiency, and both in vitro and in vivo expression/biodistribution.
  3. Vialed Final Optimized Vector: Sufficient quantity of the lead custom delivery vehicle ready for the client's subsequent research phases.
Consultation & Design
Sequence Optimization

Estimated Timeframe

The typical timeframe for this service ranges from 8 to 16 weeks, depending on the complexity of the chosen vector (e.g., LNP vs. custom eVLP) and the scope of the in vivo testing required for the therapeutic target.

What We Can Offer

As a partner to leading biology experts, Creative Biolabs' Custom mRNA Delivery Vehicle Development Services are engineered for unparalleled therapeutic precision and scalability:

End-to-End Delivery Solution
A single, integrated service covering vehicle design, proprietary component synthesis, payload formulation (Lipid, Polymer, Hybrid, eVLP), and rigorous physicochemical characterization, minimizing technical friction and accelerating your timeline.

Payload-Specific Customization
We go beyond standard formulations, optimizing vector composition (e.g., ionizable lipid pKa, N:P ratio) based precisely on your mRNA transcript size, modifications (e.g., saRNA compatibility), and expression kinetics for maximized in vivo efficacy.

Scalable and Robust Formulation
Development of processes using advanced techniques (like microfluidics) that are reproducible and scalable, ensuring a smooth transition from R&D to preclinical and large-scale GMP-compliant manufacturing.

Advanced Quality Assurance
Implementation of a Quality-by-Design (QbD) approach and stringent process controls, providing comprehensive CMC-ready documentation and data packages (including stability, PDI, and Zeta Potential) essential for regulatory submission.

Targeting & Efficacy Tuning
Expertise in surface functionalization and component selection to tune the nanosystem for specific cell targeting and controlled immunogenic profiles (immune-evading vs. immune-activating), giving you control over the therapeutic environment.

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Customer Reviews

  • Optimized Expression:Using Creative Biolabs' Custom mRNA Delivery Vehicle Development Services, our research achieved significantly improved sustained expression of the cytokine payload in the spleen. Their focus on polymer chemistry also enabled us to reduce the required dose by nearly a third.

    June 2025, Dr. James Harris

  • Superior Targeting: The enveloped virus-like particle (eVLP) system from Creative Biolabs delivered the targeted cellular uptake we could not achieve with standard lipid nanoparticles (LNPs). The dramatic increase in antigen presentation on dendritic cells (DCs) directly facilitated our cancer immunotherapy work.

    February 2025, Dr. Katherine Wang

  • Enhanced Stability: We required a vector stable under aerosolized conditions for lung delivery. Creative Biolabs provided a robust, pH-responsive peptide-based system that retained 95% encapsulation efficiency post-nebulization—far surpassing the alternatives we tested.

    November 2024, Dr. Maria Alvarez

FAQs

Q: Which delivery vehicle—LNP, Polymer, or eVLP—is best suited for my cancer vaccine project?

A: The optimal vehicle depends entirely on your antigen and target immune cell. While LNPs are widely used, a custom eVLP might offer superior T-cell activation due to its biomimetic structure. Conversely, a mannose-targeted LNP can drastically improve DC uptake.

Q: How do you ensure the stability of the final mRNA delivery system for scale-up?

A: Stability is addressed at multiple stages. First, through component selection (e.g., specific stabilizing PEGylation); second, through fine-tuning formulation parameters to achieve optimal Zeta Potential and PDI (uniformity); and third, by providing detailed QC protocols designed to predict long-term stability and guide your CMC strategy.

Q: Are your delivery systems compatible with Self-Amplifying RNA (saRNA) payloads?

A: Yes. saRNA presents a unique challenge due to its large size. We specialize in designing custom Polymer and Hybrid vectors that can efficiently condense and protect these larger transcripts, enabling strong, sustained antigen expression from a lower dose.

Q: My target cell is difficult to transfect; can a custom vehicle help with that, or should I consider electroporation?

A: Custom delivery vehicles, particularly eVLPs and highly optimized Polyplexes, are often designed to overcome inherent cellular resistance better than bulk methods like electroporation, which can damage cells and lack targeting specificity in vivo. Our vectors are engineered for high-efficiency cellular entry and endosomal escape, making them ideal for challenging cells.

Creative Biolabs offers unparalleled expertise in synthesizing, modifying, and delivering your mRNA therapeutic. Our customized vector solutions, covering Lipid, Polymer, Hybrid, and eVLP platforms, accelerate your project by providing high stability, superior targeting, and maximal efficacy, transforming your scientific discovery into a viable clinical product.

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Reference

  1. Lin, Yang, et al. "An overview of nanoparticle-based delivery platforms for mRNA vaccines for treating cancer." Vaccines 12.7 (2024): 727. https://doi.org/10.3390/vaccines12070727. Distributed under Open Access license CC BY 4.0, without modification.
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