Hzymes Biotech: Your Trusted Partner for Comprehensive mRNA CRO Services

In recent years, mRNA technology has emerged as a game-changer in the field of medicine, powering revolutionary advances in vaccines and therapeutics. As the demand for mRNA-based solutions continues to grow, so does the need for specialized support in research, development, and production. Hzymes Biotech, a global supplier of core mRNA raw materials, is proud to offer end-to-end mRNA CRO (Contract Research Organization) services to accelerate innovation in life sciences.

Global Leader in mRNA CRO Services

Hzymes Biotech has established itself as a trusted name in the mRNA biotechnology industry, supplying premium-quality raw materials and technical services to over 100 biopharmaceutical and vaccine companies worldwide. With exports to more than 25 countries and regions, the company’s international presence reflects its commitment to driving scientific progress across borders.

At the heart of our mission is the goal to streamline mRNA drug and vaccine development, making cutting-edge treatments more accessible and efficient.

One-Stop Solution for mRNA Development

At Hzymes, we simplify complexity. Our one-stop mRNA CRO solution covers every step of the development pipeline—from sequence design and plasmid construction to mRNA synthesis, Lipid Nanoparticle (LNP) formulation, and quality control.

Whether you're in early-stage research or scaling up for production, our integrated services are tailored to meet your unique needs. This holistic approach reduces time-to-market and enhances project success rates.

Stable and Self-Sufficient Raw Material Supply

Unlike many CRO providers, Hzymes Biotech produces its own raw materials, including enzymes for in vitro transcription (IVT) and mRNA synthesis components. Our proprietary T7 RNA polymerase mutants and other in-house materials ensure high performance, batch-to-batch consistency, and uninterrupted supply.

This self-reliance empowers us to deliver dependable, high-quality solutions while maintaining flexibility in customization.

Unmatched Quality Control System

Quality is our promise. Hzymes Biotech has built a rigorous quality control system with industry-recognized testing protocols. Our proprietary kits enable:

• dsRNA (double-stranded RNA) quantitative detection
• DNase residue detection
• RNase residue detection

These methods have become trusted tools for many biopharmaceutical companies and have been included in the official group standard T/FDSA 0055-2024, which guides the development of mRNA-LNP-based cellular immunotherapy products.

Innovative mRNA Technology Platform

Driven by scientific excellence, our mRNA technology and application platform integrate advanced tools and methodologies to deliver full-process services, including:

• High-efficiency plasmid template preparation
• High-throughput screening of enzymatic systems
• The proprietary STAR real-time fluorescence detection method for IVT analysis

These innovations not only ensure accuracy but also significantly shorten the timeline for mRNA vaccine and drug development.

Our Full Range of mRNA CRO Services

Hzymes Biotech offers a comprehensive suite of mRNA-related services:

• mRNA Vaccine and Drug Proof-of-Concept Studies
• Customized mRNA and LNP Synthesis
• mRNA Quality Inspection Services
• Process Development and Optimization

Each service is customizable and supported by expert teams dedicated to your success.

Case Sharing

Step 1 Sequence Design

1.Confirm amino acid sequence 

Based on the AI intelligent tool - Alphafold protein structure prediction and analysis tool, and in cooperation with the State Key Laboratory of Microbiology of Shanghai Jiaotong University, a protein structure prediction and optimization system were built

2.Decoding DNA nucleotide sequences

• Hzymes Biotech utilizes various sequence optimization tools to output nucleotide sequence files, providing support for the next optimization step
Target determination: Identify the targets for drug development.
• Optimization design: Based on MFE and CAI multi parameter combination, output multiple candidate sequences and sort them.
• Screening scheme: Based on the MFE and CAI of the selected sequence, with the standard of covering all sequence sets as comprehensively as possible, select candidate sequences and use them for wet experiments 
• Experimental verification: Through wet experiments, select the best sequence.

• Delivery of optimal sequence: The sequence delivered to the customer will be rigorously screened and most likely to become the optimal candidate for drug phenology.

3.mRNA sequence optimization

• Kozak sequence significantly increases protein expression

+ Kozak

• UTR adaptability affects the expression effect of CDS sequences

• Transcription initiation sequence

• Verification of A-tail sequence of mRNA.

4. Software predicts the secondary structure of candidate sequences

Predict the secondary structure of candidate sequences to avoid sequences with stable or hyperstable complementary structures at the 5 'level.

saRNA-EGFP MFE -2718.90

Step 2 Gene Synthesis and Plasmid Amplification

1.Strain screening - controlling yield and super helix ratio

2. Fermentation process - control OD600 and plasmid yield 

Optimize various parameters for different receptive states and plasmids:

• Cultivation medium formula 
• Fermentation tank parameters 
• Feeding formula and feeding strategy

• Fermentation tank control parameters

3. Important indicator for plasmid optimization - PolyA tail stability 

Different receptive state transformation plasmids, selecting monoclonal antibodies with stable A tail

After fermentation amplification of different plasmid skeletons, the heterozygosity of PolyA tail in sequencing quality inspection varies

By screening the receptive/monoclonal/plasmid backbone and optimizing the fermentation process, we ultimately obtained plasmids with high helix ratios and stable PolyA tails

4. Purification process

• Optimization of Cracking Process

• Molecular sieve chromatography to remove RNA

• Affinity chromatography to remove open-loop plasmids

• Ion exchange chromatography to remove endotoxins

5. Product release testing

Step 3 In Vitro Transcription to Synthesize mRNA

Product release testing

Step 4 Translation - Level Detection

Step 5 LNP Encapsulation

LNP microfluidic control preparation process

Hzymes Biotech has explored and optimized the downstream purification process for LNP, mainly focusing on the development of inlet flow rate, Trans Membrane Pressure Drop (TMP), membrane pore size, membrane area, membrane material, hollow fibers, and flat plate membrane package. The process time can be controlled at around 3.5 hours, and the stability of mRNA LNP preparation at -80 ℃ can reach more than 18 months, and it can be frozen and thawed 10 times without affecting physical and chemical indicators

Freeze thaw stability of mRNA LNP formulations

Product release testing 

Streamlined Service Process

Our mRNA CRO process is built for efficiency and transparency:

1.Submit Requirements
2.Sales Confirmation
3.mRNA Sequence Design & Optimization
4.Gene Synthesis & Plasmid Amplification
5.In Vitro Transcription (IVT) to Synthesize mRNA
6.Cellular Translation-Level Evaluation
7.mRNA-LNP Preparation
8.In Vivo Biological Evaluation

9.Final Delivery

From consultation to delivery, our team ensures smooth communication and high-quality outcomes at every stage.

A Commitment to the Future of Medicine

As a pioneer in mRNA technology, Hzymes Biotech is deeply committed to advancing human health through scientific innovation. Our goal is to empower researchers, developers, and manufacturers to create next-generation mRNA therapies that change lives.

Through our reliable mRNA CRO services, cutting-edge tools, and unwavering dedication to quality, we strive to be the partner of choice for companies shaping the future of healthcare.

Partner with Hzymes Biotech Today

Whether you're launching a new mRNA vaccine, optimizing an existing process, or seeking dependable raw materials, Hzymes Biotech has the expertise and infrastructure to support you every step of the way.