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mRNA Services

Comprehensive End-to-End mRNA Solutions

We provide fully integrated, end-to-end mRNA development, production, delivery, and analytical services to support projects from early research through IND filing and commercial scale-up. Our platform combines advanced sequence design, plasmid construction, IVT mRNA synthesis, high-purity purification, LNP formulation, and GMP manufacturing under one streamlined workflow—enabling faster timelines, superior consistency, and reduced technical risk. With deep expertise across mRNA therapeutics, mRNA vaccines, gene editing (Cas9 mRNA + gRNA), saRNA, circRNA, and mRNA-LNP delivery, we help innovators accelerate discovery and confidently advance their programs toward success. Whether you require milligram-scale research material or large-scale GMP batches, our one-stop mRNA solutions empower you to design, develop, and deliver next-generation nucleic acid medicines with speed and reliability.

Structure of an mRNA moleculeFigure 1: Schematic of an mRNA molecule

Why mRNA?

Unlocking the Next Generation of Therapeutics

Messenger RNA (mRNA) has rapidly emerged as one of the most transformative modalities in modern medicine. Its unique ability to encode virtually any protein, combined with flexible manufacturing and strong safety attributes, positions mRNA as a powerful platform for vaccines, therapeutics, and advanced cell and gene engineering.

A Versatile Platform for Multiple Applications

  • Enables the expression of virtually any protein for vaccines, gene editing, immunotherapy, and protein replacement.
  • Easily adaptable to new targets through sequence redesign without changing the manufacturing workflow.
  • Supports rapid prototyping, allowing fast iteration during discovery and preclinical development.
  • Applicable across infectious diseases, oncology, rare diseases, regenerative medicine, and next-generation biologics.

A Rapid and Scalable Manufacturing Modality

  • Produced through a cell-free IVT process that is faster and more efficient than traditional biologics manufacturing.
  • Easily scalable from microgram research batches to large GMP.
  • Highly reproducible, enabling parallel development of multiple constructs.
  • Ideal for programs requiring short timelines, such as pandemic response or personalized medicine.

A Safe, Non-Integrating Expression System

  • Delivers transient protein expression without integrating into the host genome.
  • Minimizes risks associated with viral vectors or DNA-based therapeutics.
  • Expression window can be controlled via sequence design, chemical modifications, and delivery strategy.
  • Well-suited for applications demanding precise, reversible, or localized expression.

A Modality Enhanced by Advanced Delivery Technologies

  • LNP, polymer, liposome, and exosome delivery systems improve stability and cellular uptake.
  • Enables targeted delivery to specific tissues, including liver, spleen, immune cells, and tumors.
  • Enhances protein expression efficiency through optimized formulation and encapsulation.
  • Expands therapeutic reach across systemic, local, and cell-engineering applications.

How does mRNA work in therapeutics Figure 2: How mRNA works in therapeutics

Our One-Stop mRNA Service Overview

Comprehensive mRNA Services From Research to Commercialization

We offer a broad portfolio of customizable services to accelerate every stage of your mRNA therapeutic program.

mRNA Core Services

  • mRNA, saRNA, circRNA, eRNA synthesis
  • Codon & UTR optimization
  • Plasmid design, cloning, and production
  • Linear DNA template preparation
  • IVT reaction development

Formulation & Delivery Solutions

  • LNP formulation platforms
  • Polymer- and liposome-based delivery
  • Exosome / EV delivery (optional)
  • Electroporation for immune or stem cells
  • Formulation screening & optimization
  • Stability study and buffer development

Analytical & Characterization Services

  • Identity, purity, and integrity analysis
  • dsRNA quantification
  • Capping efficiency testing
  • Potency and expression assays
  • LNP analytical panel (size, PDI, EE, zeta)
  • Method development & validation

GMP Manufacturing Services

  • GMP-grade mRNA
  • GMP plasmids
  • GMP LNP formulation
  • Fill-finish support (optional)
  • Batch release testing

Flexible Production Grades

To match your development stage and budget:

  • Research Grade
  • Preclinical Grade
  • GMP-like / Pre-GMP
  • GMP Grade
  • Commercial Grade

Custom Project Support

  • Tailored development roadmaps
  • Feasibility studies
  • Tech transfer
  • Dedicated project managers
  • IP-safe development environment

Table 1 Production Grades

Grade Application QC Level Release Documents
ResearchDiscovery & in vitroBasic QCData sheet
PreclinicalAnimal studiesExtended QCCOA
Pre-GMPTox studiesGMP-likeBatch record summary

One-Stop mRNA Workflow

End-to-End mRNA Development & Manufacturing Process

Our integrated mRNA platform streamlines every phase of development—from sequence design to GMP manufacturing—ensuring high-quality, consistent, and regulatory-ready materials. Each step is supported by cutting-edge technologies, advanced analytics, and a dedicated scientific team.

1Sequence Design & Codon/UTR Optimization

We design high-performance mRNA sequences tailored to your target protein and therapeutic goals. Key capabilities include:

  • Codon optimization for enhanced translation efficiency
  • 5'/3' UTR engineering for improved stability and protein expression
  • Signal peptide and ORF structure optimization
  • Poly(A) tail length design (50-300 A)
  • AI-assisted sequence evaluation

2Plasmid Construction & Linearized Template Preparation

Our plasmid team provides rapid vector construction and template preparation for IVT. Highlights:

  • High-accuracy cloning into standard or customized vectors
  • Plasmid production across Research → Pre-GMP → GMP grades
  • Linearization using restriction enzymes or PCR
  • Full QC including sequencing, gel analysis, and endotoxin testing

3In Vitro Transcription (IVT) mRNA Production

We synthesize high-quality mRNA using optimized IVT chemistry. Capabilities include:

  • mRNA / saRNA / circRNA / gRNA production
  • Modified nucleotides (N1-Me-Ψ, Ψ, 5moU, 5meC, m6A, etc.)
  • Capping options: Cap0, Cap1, ARCA
  • Poly(A) tail engineering
  • Scalable IVT: μg → mg → g → 250 g per batch
  • High-yield enzymatic reaction optimization

4Purification & dsRNA Removal

To ensure therapeutic-grade purity, we apply advanced chromatographic and enzymatic purification technologies. Capabilities:

  • Oligo dT affinity purification
  • HPLC / SEC / TFF workflows
  • Effective dsRNA removal
  • Removal of enzymes, DNA template, and process impurities
  • Integrity analysis via Bioanalyzer / CE

5mRNA Delivery & Formulation (LNP, Polymer, Liposome, Exosome)

A comprehensive delivery platform designed for functional expression in vitro and in vivo. Our formulation solutions include:

  • LNP encapsulation using microfluidics
  • Polymer-based delivery systems
  • Liposome formulations
  • Exosome / EV-based delivery (optional)
  • Cell engineering solutions: electroporation, lipid-mediated transfection
  • Stability & buffer optimization
  • Release QC: particle size, zeta potential, encapsulation efficiency

6Analytical Characterization & QC Testing

Rigorous quality control ensures regulatory compliance and reliable performance. Tests include:

  • Identity (MS, sequencing)
  • Purity (HPLC/CE/SEC)
  • Capping efficiency
  • Poly(A) tail analysis
  • dsRNA detection (dot blot / ELISA)
  • Integrity (Bioanalyzer)
  • Endotoxin & sterility
  • Potency assays (in vitro expression)
  • LNP QC (particle size, PDI, zeta, EE)

7GMP Manufacturing & Regulatory Support

Full support for IND and commercial production. Features:

  • GMP-compliant cleanrooms (Grade A/B/C)
  • Raw material traceability & qualification
  • Batch records, CoA, validation documents
  • Stability studies
  • CMC documentation support
  • Tech transfer & commercial-scale supply

Technical Capabilities

Advanced Engineering, Scalable Manufacturing, and Platform-Level Innovation

Our technical capabilities go far beyond standard mRNA synthesis. We operate a fully integrated mRNA engineering platform built for scalability, manufacturability, quality, and next-generation therapeutic innovation. This section highlights our core technology strengths, not individual workflow steps.

Platform Architecture & Modular Design Capability

We operate an engineering-driven mRNA platform that enables rapid adaptation across diverse RNA modalities and therapeutic strategies.

Key strengths:

  • Modular design framework supporting mRNA, saRNA, circRNA, eRNA, CRISPR mRNA, and RNA standards
  • Platformized sequence optimization models for expression, stability, and manufacturability
  • Multi-parameter design algorithms enabling de novo construct creation
  • Integrated data backbone linking design → process → QC → release
  • Rapid prototyping engine enabling parallel sequence screening

Next-Generation Delivery Science

Our capabilities extend across multiple delivery technologies, enabling tailored solutions for each therapeutic indication.

We support:

  • Proprietary LNP formulation design and lipid library screening
  • Organ-targeted delivery optimization (liver, spleen, tumor, immune cells)
  • Polymer, liposome, and hybrid carrier development
  • Electroporation engineering for immune and stem cells
  • Formulation stability engineering

Advanced Analytical & Characterization Technologies

Our analytical ecosystem provides deep structural and functional insight, surpassing basic QC requirements.

Capabilities include:

  • Structural analytics for long/complex RNA constructs (up to 20 kb)
  • dsRNA fingerprinting & impurity profile mapping
  • mRNA-LNP interaction and physicochemical modeling
  • Proteomic-based potency evaluation
  • Stability behavior prediction using accelerated stress models
  • Multi-parameter release specifications aligned with global CQA standards

RNA Chemistry Expertise

We combine molecular biology with RNA chemistry to deliver high-performance, functionally optimized mRNA constructs.

We specialize in:

  • Modified nucleotide chemistry & immunogenicity engineering
  • UTR functional tuning for application-specific expression kinetics
  • Tail-length engineering for durability & translation stability
  • Large RNA (>10kb) manufacturability optimization
  • Design of low-immunogenic or high-expression RNA variants

Table 2 mRNA Formats & Capabilities Matrix

RNA Type Max Length Modification Support Formulation Options Typical Use Case
mRNA20 kbFully supportedLNP/Polymer/LiposomeVaccines, Protein Therapy
saRNA10 kbPartialLNPVaccines
circRNA5 kbCustom optionsLNPLong-term expression
gRNA/sgRNA20–200 ntN/AElectroporationCRISPR Editing

Quality Control

Comprehensive Analytical Testing for mRNA & LNP Products

We provide a full suite of analytical assays to ensure that every mRNA product meets strict quality, safety, and regulatory standards. Our QC panel covers all critical quality attributes (CQAs) required for preclinical, GMP, and commercial use.

Identity Testing

  • Mass spectrometry (MS) for RNA identity
  • Sequence confirmation via NGS/Sanger sequencing
  • Cap structure confirmation

Purity & Impurity Analysis

  • HPLC (RP/IE/SEC)
  • Capillary electrophoresis (CE)
  • dsRNA quantification (dot blot / ELISA)
  • Residual DNA template measurement
  • Residual proteins, enzymes, nucleotides
  • RNA purity (% full-length vs truncated RNA)

Integrity & Structural Assessment

  • Bioanalyzer / Fragment Analyzer
  • Agarose gel electrophoresis
  • Poly(A) tail length measurement
  • 5'/3' end analysis

Potency & Expression Assays

  • In vitro translation assays
  • Cell-based expression quantification
  • Reporter protein assays (e.g., luciferase, GFP)
  • Functional potency testing for LNP-mRNA formulations

Capping & Modification Analysis

  • Capping efficiency measurement
  • Modified nucleotide incorporation ratio
  • mRNA modification mapping (optional)

LNP Formulation QC

  • Particle size (DLS)
  • Polydispersity Index (PDI)
  • Zeta potential
  • Encapsulation efficiency (EE%)
  • Lipid ratio verification
  • Stability and aggregation testing

Safety & Release Testing

  • Endotoxin (LAL assay)
  • Sterility testing
  • Bioburden testing
  • pH, osmolality, appearance
  • Residual solvents (if applicable)

Stability & Stress Testing

  • Accelerated and long-term stability studies
  • Freeze-thaw cycling
  • Thermal and light stability evaluation
  • Stability profiling for GMP batches

Table 3 QC Testing Matrix

CQA Category Test Method Purpose Included in
IdentityMS, sequencingConfirm RNA structureAll grades
PurityHPLC, CEDetect impuritiesPreclinical/GMP
IntegrityBioanalyzerFull-length RNAAll grades
dsRNADot blot / ELISASafety & efficacyPreclinical/GMP
PotencyCell-based assayFunctional activityPreclinical/GMP
LNP QCDLS, zeta, EE%Delivery performanceLNP batches

Applications Across mRNA-Based Modalities

Empowering Innovation Across the mRNA Therapeutic Landscape

Our end-to-end mRNA platform is purpose-built to accelerate breakthroughs across the most dynamic fields in modern medicine. From vaccines and gene editing to cell therapy and regenerative medicine, we provide the technical expertise, manufacturing capacity, and regulatory readiness needed to advance your program with confidence.

mRNA Vaccines

Transforming Prevention and Personalized Immunity

mRNA enables rapid, flexible vaccine development by encoding viral antigens or tumor neoantigens directly inside host cells. Whether targeting emerging infectious diseases or designing personalized cancer vaccines, mRNA offers unmatched adaptability and speed.

How we support your vaccine program:

  • Rapid antigen sequence design and optimization
  • High-yield IVT mRNA
  • LNP formulations engineered for strong immunogenicity
  • Full CQA vaccine analytics and stability studies
  • GMP manufacturing

Gene Editing

Precision Tools for Next-Generation Genetic Medicines

mRNA is the gold standard for delivering gene editing machinery safely and transiently, minimizing off-target risks while enabling highly efficient genome modification.

Supported use cases:

  • CRISPR-Cas9 / Cas12a / Cas13 mRNA
  • Base and prime editing
  • sgRNA / crRNA / tracrRNA production
  • In vivo and ex vivo editing platforms

How we accelerate your gene editing work:

  • Large ORF-compatible mRNA engineering
  • Electroporation-optimized formats for T, NK, and stem cells
  • LNP systems for in vivo genome editing
  • Potency, integrity, and editing-performance analytics

Protein Replacement Therapies

Restoring Function Through mRNA-Encoded Proteins

mRNA provides a powerful alternative to recombinant proteins by enabling sustained, endogenous expression of therapeutic proteins without genomic integration or viral vectors.

Applicable protein classes:

  • Enzymes for metabolic disorders
  • Hormones and growth factors
  • Transporters and functional proteins
  • Monoclonal antibodies and engineered fragments

Our support includes:

  • High-expression constructs with optimized UTRs
  • Low-immunogenic modified mRNA
  • Organ-targeted LNP delivery
  • Protein expression and potency assays

mRNA-Encoded Antibodies & Immune Modulators

Redefining Biologics With In Vivo Expression

mRNA can encode complex therapeutic antibodies directly within the patient, enabling rapid response capabilities and superior pharmacokinetic profiles.

Use cases include:

  • Neutralizing antibodies
  • Bispecifics and multi-specifics
  • Immunomodulatory proteins for oncology and autoimmune disease

Our platform capabilities:

  • Co-expression strategies for heavy/light chains
  • High-fidelity synthesis of long and complex mRNA
  • Formulation systems optimized for systemic delivery

CAR-T / TCR Cell Engineering

Faster, Safer, Non-Integrating Gene Delivery

For ex vivo cell therapy, mRNA offers rapid, non-integrating expression of CARs, TCRs, co-stimulatory molecules, and editing enzymes, accelerating manufacturing without genomic disruption.

We empower your cell therapy workflows with:

  • Electroporation-ready GMP mRNA
  • High-purity sgRNA for genome engineering
  • Scalable supply for CAR-T manufacturing
  • Potency assays and expression analytics in immune cells

Regenerative Medicine

Driving Tissue Repair and Functional Recovery

mRNA delivers precise, transient expression of growth factors and regenerative signals—an ideal modality for tissue repair without long-term genetic alteration.

Applications include:

  • Angiogenesis (VEGF, FGF)
  • Bone and cartilage regeneration (BMP family)
  • Wound healing cytokines
  • Anti-inflammatory mediators

Our value:

  • Tailored expression kinetics
  • LNP or local-delivery formulations
  • Scalable GMP supply

Rare Disease Therapeutics

Rapid, Flexible Solutions for Ultra-Orphan Indications

For monogenic disorders, mRNA enables targeted protein restoration with minimal development timelines—an essential advantage in rare disease drug development.

Our capabilities include:

  • Long and complex mRNA up to 20 kb
  • Ultra-pure GMP manufacturing for niche indications
  • Customized release and stability testing
  • CMC-ready documentation for accelerated approval pathways

RNA Diagnostics & Molecular Tools

High-Precision Synthetic RNA for Analytical Innovation

Synthetic mRNA and RNA standards are essential tools for molecular diagnostics, assay development, and analytical workflows.

We provide:

  • High-fidelity mRNA/RNA reference standards
  • Ultra-pure IVT RNA controls
  • Flexible mg-g scale supply
  • Sequence-verified, degradation-resistant formulations

Ready to Accelerate Your mRNA Research and Development?

Our scientific and engineering teams are committed to supporting your mRNA innovation—from sequence design and IVT production to advanced formulation, delivery optimization, and comprehensive analytical characterization. With a fully integrated platform and deep expertise across RNA modalities, we help you move faster, scale smarter, and achieve consistent high-quality results. Collaborate with a partner who understands the science and the technology behind next-generation mRNA solutions. Connect with our experts to discuss your project needs.

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