GMP-like mRNA Manufacturing Services

Accelerate your mRNA project to IND

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

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 >>

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 & PolyA tail

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

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

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

Learn More

LNP Formulation

Learn More

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with GenScript IVT mRNA
Production Services

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EMAIL

gene@genscript.com

PHONE

1-877-436-7274

ONLINE FORM

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Quality	Attribute	Method	Specification
Identity	Sequencing	Sanger Sequencing	> 98% alignment
Identity	Sequencing	NGS by Illumina	Q20 Ratio > 95%
Content	Concentration	UV Absorbance	0.5 - 2.0 mg/mL or Target ± 5%
Content	Concentration	Qubit	0.5 - 2.0 mg/mL or Target ± 5%
Length	mRNA Length	TapeStation	Target ± 15%
	mRNA Length	Capillary Electrophoresis	Target ± 30%
	mRNA Length	Agarose Gel Electrophoresis	Expected band size detected
Purity	A260/280 Ratio	UV Specification	1.70 - 2.30
	Size-Based Purity	Capillary Electrophoresis	≥ 75%
	Capping Efficiency	Enzyme Digestion to LC-MS	≥ 90%
	Poly(A) Tail Length	Enzyme Digestion to LC-MS	Target ± 5%
	Residual Protein	NanoOrange Assay	≤ 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	< 4 EU/mg
Safety	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

GMP-like mRNA Manufacturing Services

Accelerate your mRNA project to IND

Overview