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Home » IVT RNA Production Services » IVT mRNA Production » GMP-like mRNA Manufacturing Services

Overview

GenScript offers high-quality, scalable, and regulatory-compliant mRNA production to support your preclinical, IND, and early-phase clinical studies.

We provide comprehensive support across all key preclinical stages—including assay design for preclinical optimization, assay qualification for clinical trial readiness, analytical procedures and method development, stability studies under various environmental stressors, and toxicology studies for preclinical safety assessment.

All processes are conducted in Grade C clean room environments to ensure consistent quality and minimize contamination risks.

Our GMP-like services bridge the gap between research and full cGMP manufacturing, accelerating time to market while ensuring cost efficiency.

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IVT RNA Services

Accelerated Timelines for Preclinical and IND-Enabling Studies

Our GMP-like service is designed to fast-track your mRNA development process. With optimized workflows and rapid turnaround times, we help you move from research to IND submission more quickly—without compromising on quality.

Scalable and Customizable Production

Whether you're developing a vaccine, therapeutic, or genetic medicine, we offer flexible options in mRNA design—cap structures, modifications, poly(A) tail length, and comprehensive QC testing—to support your specific scientific and regulatory needs at scale.

Phase-Appropriate Quality with Regulatory Alignment

We offer rigorous quality control and documentation, including batch records, CoAs, and TSE/BSE statements, performed under Grade C clean room conditions. The quality of mRNA drug substances and products depends on their design, manufacturing process, and the specifications applied throughout development. Our testing approach includes validated analytical methods for starting materials, in-process monitoring, release, and stability to ensure product consistency, safety, and efficacy. We assess critical quality attributes—such as identity, purity, integrity, potency, and encapsulation efficiency—at each stage to support comparability, shelf-life, and IND-enabling decisions.

Service Highlights

Template Design & Optimization

Licensable GenCap™
Technology

Leverages a proprietary co-transcriptional capping method to deliver mRNA with ≥95% capping efficiency, enhancing transcript stability and translation yield

Template Design & Optimization

Strong Expertise in optimized IVT system to improve yield & reduce dsRNA

6,200+ projects delivered. Expertise in mRNA codon optimization, UTR engineering, and ORF screening based on your target application

Capping & PolyA tail

IVT mRNA Synthesis & Characterization

Strong mRNA characterization platform and experienced team to provide advanced QC analysis for RNA characterization and support your IND filing data preparation

Comparison with Research and GMP-like

GMP-like mRNA RUO mRNA
Intended Use Preclinical & IND-enabling studies Research only (e.g., screening, discovery)
Cleanroom Standard Grade C cleanroom environment; ISO classified production suites Not required
Quality Control (QC) Preclinical QC including identity, purity, quantity, physical state (integrity) and safety aligned with USP guidelines Standard QC (e.g., RNA length, purity, impurity)
Regulatory Compliance IND support documentation, CoA, TSE/BSE statements No regulatory documentation
Documentation Provided Batch records, CoA, preclinical-grade documentation, TSE/BSE, manufacturing summary report Basic data sheet
Process Traceability Full traceability with controlled procedures Limited
Customizability Fully customizable with phase-appropriate QC, documentation, process development/engineering Sequence, modifications, tail length
Typical Use Cases Toxicology, biodistribution, IND submissions Screening, basic functional studies
Turnaround Time From 7 weeks, flexible based on customers’ requirement Fast
2 weeks
Additional Capabilities Master cell bank generation, product-specific master batch records, environmental monitoring -

Why Choose GenScript’s GMP-like mRNA Manufacturing?

mRNA Development Pathway: From RUO to pre-clinical stage from 7 weeks

Comprehensive mRNA Cap, Tail, and QC Configuration for Preclinical Use

Selecting the Cap

  • No Cap
  • Cap 0
  • Cap1AG: m7G(5’)pppA(2’-O-Me)pG
  • Cap1AU: m7G(5’)pppA(2’-O-Me)pU
  • GenCap™ (Patented technology)
  • Other. Customer provided Cap analogues

UTR and Sequence

  • Proprietary UTRs designed for tissue-specific and tumor-targeted expression
  • Enable customized mRNA design for greater expression control and application-specific performance
  • GenSmart or X5 codon optimization for higher expression

Modifications and PolyA tail length

Modifications

  • N1-Me-Ψ
  • 5moU
  • Ψ & 5meC
  • Cy5-UTP or Thio-CTP
  • Unmodified

PolyA tail length

  • 100A tail
  • Custom tail ≤ 120A
  • No tail

QC methods

  • Preclinical standard
  • Preclinical upgrade
  • Our GMP-like mRNA services follow the latest industry guidance and cover extensive quality control attributes including identity, integrity, purity, potency, and safety.
More Info >>

QC Specifications

Quality Attribute Method Specification
Identity Sequencing Sanger Sequencing > 98% alignment
Sequencing NGS by Illumina Q20 Ratio > 95%
Content Concentration UV Absorbance 0.5 - 2.0 mg/mL or Target ± 5%
Concentration Qubit 0.5 - 2.0 mg/mL or Target ± 5%
Length mRNA Length TapeStation Target ± 15%
mRNA Length Capillary Electrophoresis Target ± 15%
mRNA Length Agarose Gel Electrophoresis Expected band size detected
Purity A260/280 Ratio UV Specification 1.70 - 2.30
Size-Based Purity Capillary Electrophoresis < 5kb: ≥85%
> 5kb: ​≥80%
Capping Efficiency Enzyme Digestion to LC-MS ≥ 95%
Poly(A) Tail Length Enzyme Digestion to LC-MS Target ± 5%
Residual Protein NanoOrange Assay ≤ 0.1%
Residual DNA Template qPCR ≤ 0.05%
dsRNA Immunoblot ≤ 0.1%
dsRNA ELISA ≤ 0.1%
Aggregate mRNA SEC-HPLC < 20%
Fragment mRNA RP-HPLC < 25%
Safety Endotoxin Quantitative < 1 EU/mg
Bioburden Direct Inoculation No growth after 72 hours
Other Appearance Visual Inspection Clear and free of foreign particles
pH pH Strip or pH meter Target ± 0.5
Buffer Specification Client Specification N/A

Partner with GenScript

With over 20 years of nucleic acid expertise and a global track record in biologics manufacturing, GenScript is your trusted partner for early-stage mRNA development. Whether you are optimizing a new therapeutic or preparing for clinical scale-up, our GMP-like service is designed to help you move fast, stay compliant, and reduce risk .

Start Your Project

Contact us to discuss your project and receive a free consultation on how GenScript’s GMP-like mRNA services can support your pipeline.

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EMAIL

gene@genscript.com

PHONE

1-877-436-7274

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