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mRNA Manufacturing & CDMO Services

End-to-end mRNA manufacturing workflow End-to-end mRNA manufacturing workflow

End-to-End GMP Manufacturing for mRNA, LNP, and Drug Product Fill-Finish

Our integrated mRNA manufacturing platform provides biotech and pharmaceutical partners with a fully unified, GMP-compliant workflow encompassing sequence engineering, plasmid DNA production, high-yield IVT synthesis, advanced purification, precision LNP formulation, and aseptic drug product fill-finish. Designed for programs requiring robust scalability, high purity, and consistent performance, our end-to-end system ensures seamless coordination across every stage of production. With data-driven process control, high-throughput analytics, and tightly aligned upstream and downstream operations, we deliver reliable RNA and LNP materials that support rapid development cycles, efficient scale-up, and reproducible manufacturing outcomes—empowering partners to accelerate innovation while maintaining uncompromising quality.

Our mRNA CDMO Capabilities

Plasmid DNA (pDNA) Manufacturing

High-quality plasmid DNA optimized for IVT mRNA production.

Capabilities include:

  • Research-grade, GMP-like, and GMP production
  • High-copy and low-copy constructs
  • Enzymatic linearization
  • Endotoxin-controlled purification
  • Custom QC analytics

Deliverables: MCB/WCB, plasmid DNA, linearized DNA templates.

mRNA Process Development & IVT Synthesis

A robust, scalable in vitro transcription platform engineered for consistent high yields.

Services include:

  • mRNA sequence design & optimization
  • Modified nucleotides (e.g., N1-methyl-pseudouridine)
  • Small- to large-scale IVT reactions
  • Removal of DNA, dsRNA, and process-related impurities
  • Chromatography & TFF-based purification

Scale Options:

  • R&D: 1-50 mg
  • Preclinical: 50 mg-1 g
  • GMP: 1-10+ g per batch (expandable)

LNP Formulation & Characterization

Precision microfluidic delivery systems optimized for mRNA, saRNA, and circRNA.

Key strengths:

  • Customizable lipid compositions
  • Particle size tuning (50-120 nm)
  • High encapsulation efficiency
  • Low PDI for uniform performance
  • DOE-based formulation screening

Applications: vaccines, gene-editing, protein-replacement therapies.

GMP Drug Product Fill-Finish

Sterile manufacturing and cold-chain-ready packaging.

  • Aseptic filling into vials or syringes
  • Multiple storage temperature options
  • Stability programs and release testing
  • Flexible batch sizes
Package Includes Best For
RNA Build PackagePlasmid → IVT mRNARapid prototyping
Delivery PackagemRNA → LNP formulationDelivery optimization
Full-Stack mRNA PackagePlasmid → mRNA → LNPOne-stop development
DP PackageLNP → Fill-FinishFinal product preparation

Analytical & Quality Testing

mRNA analytics

Integrity and purity (CE / Bioanalyzer)

  • 5' cap analysis
  • Poly(A) tail characterization
  • dsRNA quantification
  • HPLC & LC-MS-based assays

LNP analytics

  • Particle size & PDI
  • Encapsulation efficiency
  • Lipid ratio confirmation
  • Zeta potential
  • Morphology characterization

GMP and general QC

  • Sterility
  • Endotoxin
  • Residual DNA/RNase
  • Osmolality & pH
  • Appearance and identity tests

Why Partner With Us?

Choosing the right CDMO partner is critical for accelerating RNA program development while ensuring consistency, scalability, and uncompromising quality. Our platform combines integrated manufacturing, advanced analytics, GMP-compliant operations, and deep technical expertise to help biotech and pharmaceutical teams progress faster with confidence. We deliver a seamless end-to-end experience—from plasmid DNA and IVT mRNA to LNP formulation and final drug product—supported by data-driven process control and transparent project communication.

  • One Partner From Sequence to Final Drug Product: Reduce time, complexity, and fragmentation with a unified workflow covering plasmid DNA → mRNA → LNP → fill-finish.
  • High-Performance Manufacturing Designed for Scale: Support for R&D batches up to multi-gram GMP-level production with identical process architecture for seamless scale-up.
  • Data-Rich Manufacturing & Transparent Project Management: Real-time updates, milestone reporting, and detailed analytics ensure visibility and predictable delivery.
  • Industry-Grade Quality Systems: Robust GMP facilities and validated workflows ensure reproducibility, traceability, and exceptional product quality.
  • Flexible, Fast, and Built for Innovation: Optimized for rapid onboarding, short lead times, and customizable technical workflows tailored to each program.

Our Manufacturing Strength

Advanced Infrastructure Built for Scalability, Quality, and Consistency

Our manufacturing ecosystem is engineered to support high-quality mRNA and LNP production across a wide range of research and development needs. With a combination of precision equipment, automated workflows, and fully integrated process controls, we deliver reliable, reproducible output at every scale.

Engineering-Centered Production Environment

  • Dedicated production suites designed for high-purity RNA synthesis and formulation
  • Controlled environments for RNA handling, storage, and processing
  • Streamlined material flow to minimize contamination risk
  • Automated mixing, purification, and filtration systems for consistent performance

High-Capacity Equipment & Flexible Scale Options

  • Scalable IVT reactors supporting microgram to multi-gram production
  • High-throughput purification systems using chromatography and TFF
  • Microfluidic-based LNP formulation lines optimized for uniform particle generation
  • Integrated stability and characterization equipment to support development workflows

Integrated Analytical Ecosystem

  • Purpose-built QC labs supporting identity, purity, integrity, and delivery analytics
  • Continuous monitoring and data capture for process transparency
  • Consistent performance benchmarking across batches and platforms

Built for Speed, Reliability, and Expansion

  • Parallel production lines for fast turnaround
  • Modular infrastructure designed to accommodate new RNA and delivery modalities
  • Dedicated technical support teams to optimize scale, yield, and consistency

This manufacturing foundation ensures your programs benefit from repeatable, scalable, and high-performance production, regardless of complexity or sequence type.

Equipment & Instrumentation

Category Key Equipment Purpose
UpstreamBioreactors, plasmid fermenterspDNA preparation
IVTAutomated IVT reactorsHigh-yield transcription
PurificationTFF/UFDF systems, chromatographyHigh-purity RNA
LNPMicrofluidic mixersControlled particle formation
QC LabsHPLC, CE, DLS, LC-MSAnalytical characterization

Our Differentiators

A Platform Engineered for Innovation, Precision, and High-Performance mRNA Solutions

We are more than a supplier—our platform is built to help innovators move faster, solve complex technical challenges, and unlock new therapeutic possibilities. Our differentiators reflect deep expertise across mRNA engineering, delivery science, process design, and advanced analytics.

Integrated End-to-End mRNA Platform

Unlike fragmented service providers, we offer a seamless ecosystem encompassing design, synthesis, purification, formulation, and analytics—all under one unified platform. This reduces variability, accelerates development, and enhances data continuity.

Advanced Delivery Science Across Multiple Modalities

We offer more than standard LNP formulation.

Our delivery portfolio includes:

  • LNP with customizable lipid compositions
  • Polymer- and liposome-based carriers
  • Exosome-inspired delivery concepts
  • Electroporation-optimized formats for cell-based applications

This breadth supports a wider range of research strategies and biological targets.

Deep Expertise in Complex and Large RNA Constructs

We specialize in challenging RNA formats, including:

  • Long ORFs up to 20 kb
  • Self-amplifying RNA (saRNA)
  • Circular RNA (circRNA)
  • Multi-component systems (mRNA + gRNA)

Our engineering-first approach ensures efficient production and consistent quality, even for demanding constructs.

Data-Driven Process Optimization & Predictive Engineering

Our development workflows leverage:

  • Statistical DoE models
  • Real-time process monitoring
  • Predictive analytics for expression and stability
  • Batch-to-batch performance benchmarking

This enables faster optimization cycles and superior reproducibility.

High-Quality Output Enabled by Precision Purification

Our purification technologies ensure:

  • Ultra-low dsRNA content
  • High full-length RNA percentage
  • Stable and uniform LNP populations
  • Clean impurity profiles optimized for downstream evaluation

Quality is built into every stage—not just tested at the end.

Cross-Disciplinary Innovation Culture

Our teams integrate expertise across RNA biology, chemistry, nanotechnology, materials science, and process engineering.

This cross-functional structure empowers us to solve problems creatively and support unconventional research paths.

Industries & Use Cases

Our mRNA manufacturing platform supports a wide spectrum of applications across the biotechnology and pharmaceutical sectors. Each area is backed by scalable mRNA production, advanced LNP delivery, and robust quality systems.

Vaccine Developers

Supporting next-generation mRNA and saRNA vaccine pipelines.

  • Antigen-encoding mRNA production supporting infectious disease and oncology programs.
  • Rapid sequence-to-material workflows for fast iteration and candidate screening.
  • LNP formulation optimization to achieve desired immunogenicity and delivery profiles.
  • High-purity RNA manufacturing designed for strong expression and low innate immune activation.
  • Flexible batch sizes for prototype, pilot, and scale-up manufacturing.

Protein & Antibody Expression

(mRNA-encoded Biologics)

Accelerating programs requiring controlled, transient expression of functional proteins.

  • High-yield IVT mRNA synthesis for antibody chains, cytokines, and therapeutic proteins.
  • Codon/UTR/poly(A) optimization to enhance translation efficiency and stability.
  • Customized modified-nucleotide incorporation for improved protein expression.
  • LNP delivery tuning to adjust biodistribution and expression kinetics.
  • Analytical characterization ensuring integrity, purity, and expression consistency.

Gene Editing & Delivery

Designed for RNA-delivered genome engineering systems.

  • Cas mRNA manufacturing with high integrity and low dsRNA content.
  • Production of guide RNAs (gRNA) or other regulatory RNAs to support CRISPR-based workflows.
  • LNP formulation for nuclease delivery, including particle size tuning for intracellular uptake.
  • High-purity RNA processing to reduce off-target immune responses.
  • Scalable workflows supporting rapid prototyping of gene-editing payloads.

RNA Therapeutics Innovators

Enabling differentiated therapeutic programs across multiple modalities.

  • mRNA synthesis for rare disease and metabolic disease applications.
  • Platform-based RNA manufacturing for companies building large therapeutic pipelines.
  • Support for novel constructs, including long mRNAs and multi-domain designs.
  • Microfluidic LNP engineering for targeted or tissue-selective RNA delivery.
  • Custom QC panels aligned to the specific mechanism of action of the RNA therapeutic.

RNA Technology Platform Developers

(saRNA, circRNA, novel RNA designs)

Supporting emerging RNA modalities with specialized manufacturing and analytics.

  • saRNA manufacturing with optimized IVT workflows for longer-length RNA templates.
  • Circular RNA (circRNA) production, including template preparation and purification.
  • Sequence engineering support for stability and extended expression profiles.
  • Advanced characterization tools suitable for complex RNA structures.
  • LNP formulation for next-generation delivery systems, with adjustable physicochemical profiles.

Drug Delivery & Nanomedicine

Providing advanced formulation and nanoparticle characterization capabilities.

  • Custom LNP development using diverse lipid compositions.
  • Particle size, charge, and PDI tuning for desired delivery outcomes.
  • Encapsulation efficiency optimization for mRNA, saRNA, and circRNA.
  • Material compatibility and stability studies across storage temperatures.
  • Scalable LNP manufacturing for R&D, pilot, and gram-scale production.

Discovery & Preclinical Program Teams

Helping research organizations generate material quickly for exploratory work.

  • Rapid mRNA prototyping for early feasibility studies.
  • Low- to mid-scale batches supporting multiple design iterations.
  • Flexible LNP screening using microfluidic systems.
  • Fast analytical turnaround to evaluate purity, expression, and delivery performance.
  • Consistent processes that allow seamless scale-up to larger batches as programs advance.

Accelerate Your mRNA Program with a High-Performance CDMO Partner

Our end-to-end manufacturing platform delivers the reliability, scalability, and technical depth needed to advance modern RNA therapeutics. Whether you are optimizing early prototypes or scaling established processes, we provide the infrastructure and expertise to help you move faster—without compromising quality.

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