GMP-like mRNA Manufacturing Services

Accelerate your mRNA project to IND enabling study with
GenScript’s trusted preclinical manufacturing platform from 7 weeks

GMP-like mRNA Manufacturing Service Highlights Contact Us

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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

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	UTR and Sequence	Modifications and PolyA tail length	QC methods
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	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 N1-Me-Ψ 5moU Ψ & 5meC Cy5-UTP or Thio-CTP Unmodified PolyA tail length 100A tail Custom tail ≤ 120A No tail	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 >>

Selecting the cap

UTR and Sequence

Modifications and PolyA tail length

QC methods

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

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

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

PolyA tail length

100A tail
Custom tail ≤ 120A
No tail

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 >>

Service Highlights

Template Design & Optimization

Codon optimization, UTR engineering, and ORF screening based on your target application

IVT mRNA Synthesis

DOE optimized co-transcriptional capping method with polyA built in plasmid as template, product mRNA with low dsRNA from the beginning

Capping & Tailoring

Post transcriptional enzymatic capping and tailing method available

Purification

Optimized Purification technologies to remove dsRNA and residuals to recover full length mRNA with high purity

Formulation

mRNA in storage buffer or pre-formulated with LNP for functional delivery

Comprehensive QC Panel

Our QC tests cover identity, content integrity, purity, potency, and safety attributes >>

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.

Comparison with Research and GMP-like

	RUO mRNA	GMP-like mRNA
Intended Use	Research only (e.g., screening, discovery)	Preclinical & IND-enabling studies
Regulatory Compliance	No regulatory documentation	IND support documentation, CoA, TSE/BSE statements
Cleanroom Standard	Not required	Grade C cleanroom environment
Quality Control (QC)	Standard QC (e.g., RNA length, yield)	Enhanced QC including residuals, endotoxin, BioBurden, etc.
Documentation Provided	Basic data sheet	Batch records, CoA and analytical test, preclinical-grade documentation, TSE/BSE statement
Process Traceability	Limited	Full traceability with controlled procedures
Customizability	Sequence, modifications, tail length	Fully customizable with phase-appropriate QC and documentation
Typical Use Cases	Screening, basic functional studies	Toxicology, biodistribution, IND submissions
Turnaround Time	Fast 2 weeks	From 6 weeks, flexible based on customers’ requirement

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.

Get Started Today

Quote/Order

FAQ

How does GMP-like differ from full GMP?

GMP-like follows near-GMP standards but is optimized for speed and cost in early development, whereas full GMP is required for Phase I/II/III and commercial supply. Schedule a consult
What QC testing is included?

We offer a comprehensive QC panel covering identity, integrity, purity, potency, residual DNA/RNA template, endotoxin, sterility, and encapsulation efficiency (for LNPs RUO). Stability testing and method development support are also available to ensure product shelf-life and regulatory readiness.
Can I transition from GMP-like to full GMP at GenScript?

We can provide cGMP mRNA through our sister company ProBio. Please contact our technical support team.

Related Services

Discover and Screening services

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LNP Formulation

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Production Services

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EMAIL

gene@genscript.com

PHONE

1-877-436-7274

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