As a platform technology, some advantages of mRNA therapy as a new therapeutic modality over conventional methods are its relatively simple manufacturing, short production cycle and flexibility. mRNA has the potential to deliver almost all proteins as a means of infectious disease prevention, tumor therapy, cell therapy, gene editing and other application. –

Hzymes provides one-stop custom mRNA CRO servicess, including sequence design, proof-of-concept study(POC), custom mRNA(LNP) synthesis production, mRNA analytical development&testing services which help to accelerate your R&D process from scientific discovery to massive production.

Part One: mRNA Sequence Design and POC Service

Our mRNA Proof of concept (POC) study services consist of mRNA sequence design, plasmid construction, IVT&LNP encapsulation as well as protein expression and immunogenicity validation in vivo/ in vitro which can help clients rapidly complete the feasibility study of any new mRNA target/gene.

Feature:

Experienced with multiple POC projects for human/veterinary vaccines from sequence design to in vivo assay.

Provide guidance to antigen and sequence design by predicting the secondary structure of proteins with alphafold.

Comprehensive QC tests panel to ensure the quality of mRNA and LNP

Timeline and Deliverables

Service	Timeline (Business day）	Deliverables
Sequence design	5	10 candidate sequences
Plasmid construction and amplification	30	Provide synthesised original plasmid (1-2 μg), with its sequence files
mRNA synthesis	5	Provide a test report for mRNA solution
In Vitro mRNA expression validation	10	Provide a test report for mRNA expression levels in cells
LNP encapsulation	10	mRNA-LNP for custom gene with its test report
In vivo expression validation +Cellular immunity +humoral immunity (optional)	20	Test report

Case Study: POC of a mRNA vaccine for infectious disease

Part Two: Custom mRNA(LNP) Synthesis Production Service

To help customers obtain a customized mRNA or LNP for R&D, Hzymes provides custom mRNA (LNP) synthesis production service from 500ug to gram scale.

Feature:

Comprehensive QC tests panel to ensure the quality of mRNA and LNP
Cost-effective and short project timeline.
Concise and scalable microfluidic platform for mRNA-LNP production
Complete one-stop solution with flexible choice from 500ug to gram scale production

Timeline and Deliverables

Service	Timeline（Business day）	Deliverables
Sequence Design	5	Sequence files
From Template preparation to mRNA synthesis	20	Provide sequence files of plasmid and mRNA solution with its COA. Provide synthesised original plasmid (1-2 μg) if required by client.
LNP Encapsulation	5	LNP and COA

Part Three: mRNA Analytical Development & Testing Service

Quality control is one of the most important aspects of drug development. Hzymes provides One-stop CMC quality control services for mRNA drug substance and LNP.

Feature:

mRNA capping efficiency detection
mRNA Poly(A) distribution detection
Plasmid analysis method development and validation
Development and validation of analytical methods for LNP component content analysis
Product and process impurity studies

Timeline and Deliverables

Service	Timeline（Business day）	Deliverables	Method
Capping efficiency Detection Probe  Design & synthesis	5	Probe	/
Capping efficiency Detection	10	Detection report	LC-MS
Poly（A） distribution detection	10	Detection report	LC-MS
dsRNA	1	Detection report	ELISA
Total protein residues	1	Detection report	Nano Orange
DNA template residue	1	Detection report	Quantitative Real-time PCR
endotoxin	1	Detection report	LAL
RNase residue	1	Detection report	Fluorescence probe method
DNase residue	1	Detection report	Fluorescence probe method
Host DNA residue	1	Detection report	Quantitative Real-time PCR
NTP and cap analogue residue	1	Detection report	HPLC
mRNA Integrity	1	Detection report	CE