Microbial CRDMO Solutions with excellence in quality and global regulatory compliance
mRNA CDMO Services
Since establishing its mRNA platform in 2022, Yaohai Bio-Pharma has supported over 800 RNA projects for universities, research institutes, and biotech companies. Built on expertise in plasmid DNA production, IVT process development, purification, LNP formulation, and analytical testing, our integrated platform supports mRNA programs from early development to GMP manufacturing, helping global partners accelerate timelines with reliable CMC support.
Built on over 10 years of experience in the mRNA field and fully integrated mRNACRDMO capabilities, Yaohai Bio-Pharma proudly offers the “RNASUP” platform. Our end-to-end mRNA services cover plasmid preparation, mRNA synthesis and purification, LNP encapsulation, GMP manufacturing, and regulatory support.
Protein Replacement Therapies
mRNA-encoded Immunogens
Antibody Therapeutics (e.g., T-cell Engagers)
mRNA Vaccines
In Vivo CAR Therapies
In Vivo Gene Editing
Our end-to-end mRNA CRDMO platform supports projects from early-stage R&D (mg scale) to commercial-scale production (tens of grams), while meeting EMA and FDA GMP requirements.
RNASUP End-to-End mRNA CRDMO Platform
The platform covers plasmid template preparation, mRNA synthesis and purification, process scale-up and GMP manufacturing, as well as mRNA quality analysis and quality control.
Service Platform
Yaohai Bio-Pharma has established robust and mature platforms for plasmid production, mRNA synthesis, and LNP formulation, providing end-to-end support for global clients across key development stages, from early R&D and clinical-stage process development to GMP manufacturing, analytical testing, drug product fill-finish, and regulatory submission support.
Integrated mRNA Service Platform
Our service platform supports mRNA projects across the full development stages, from early research to commercialization.
Service Highlights
Why Choose Our mRNA CRDMO Services
End-to-End mRNA Solutions
Our end-to-end mRNA CRDMO services cover the full workflow, from plasmid production and mRNA drug substance preparation to LNP-formulated drug product manufacturing, enabling efficient execution and reliable project delivery.
Comprehensive Lifecycle Support
We support mRNA projects across the full development lifecycle, from early R&D and clinical-stage process development to GMP manufacturing, analytical testing, fill-finish, and regulatory support, with flexible solutions tailored to each project.
Strict QualitySystem
Leveraging extensive platform experience, Yaohai Bio-Pharma has established a scalable mRNA platform designed for high capping efficiency, high integrity, and low residual impurities, helping accelerate project progression to commercialization.
Global Compliance
Our cGMP facilities operate in compliance with U.S. and EU GMP standards, supported by proven regulatory experience across global development and manufacturing programs.
mRNA CRDMO Service Cases
Representative mRNA CRDMO case results demonstrate Yaohai Bio-Pharma’s capabilities in plasmid quality control, linearization efficiency, capping efficiency, and poly(A) characterization throughout mRNA development and manufacturing.
mRNA Manufacturing FAQs
What different RNA formats are supported by your mRNA platform?We provide a comprehensive IVT mRNA platform supporting the production and customization of various RNA configurations, including:
Non-replicating mRNA: Linear mRNA and high-purity circular RNA (circRNA) produced via our proprietary preparative HPLC purification processes.
Self-amplifying mRNA: Industry-leading self-amplifying RNA (saRNA / taRNA) based on vectors such as VEEV, designed for more prolonged protein expression in vivo.
What lipid formulations and targeting modifications do you support for LNP delivery systems?We not only provide routine encapsulation services for classic formulations (such as SM-102, ALC-0315, and MC3 LNP), but also feature advanced targeted LNP (tLNP) technology platforms:
SORT LNP: Formulations incorporating DOTAP or 18PA to enhance organ tropism, such as spleen-targeting delivery.
Active Targeting: Validated antibody-conjugated LNP (Ab-LNP) and peptide-conjugated LNP technologies for precise cellular or organ-targeted delivery.
What starting materials do clients need to provide?
For sequence design and synthesis services: You only need to provide the peptide or nucleotide sequence (supporting natural or engineered UTRs, varying PolyA tail lengths, and codon optimization).
For in vitro transcription (IVT) or purification services: You can directly provide linearized plasmid templates or PCR products.
What are the available product forms and specifications for final delivery?We offer flexible delivery formats:
Product Types: Delivery options include purified naked RNA, LNP-encapsulated products, or a rich inventory of ready-to-use reporter genes, pathogen antigens, tumor antigens, and gene-editing mRNA/circRNA/saRNA samples.
Packaging Specifications: Flexible specifications ranging from microgram scales (100mg, 200mg) to milligram scales (1mg to 10mg), delivered in either liquid solution or lyophilized powder forms according to your requirements.
What are your quality control (QC) and LNP encapsulation standards?We utilize microfluidic mixing technology for LNP encapsulation and execute rigorous quantitative analyses of critical quality attributes (CQAs):
Core LNP Metrics: Encapsulation efficiency (EE > 85%), particle size (Size < 200nm), and polydispersity index (PDI < 0.2).
Physicochemical & Biological Testing: Includes appearance, pH, osmolarity, RNA integrity (CGE-LIF), capping efficiency (LC-MS), residual dsRNA, host cell protein/DNA residues (HCP/HCD), and in vitro/in vivo potency testing.
Do you support CMC and GMP regulatory filings from preclinical to clinical stages?Yes. We have established comprehensive analytical method development and validation systems covering plasmids, mRNA/circRNA drug substances (DS), and LNP drug products (DP). We offer complete batch testing, release testing, and custom quality standards research services, fully compliant with preclinical and clinical-stage filing requirements.
Yaohai Bio-Pharma delivers tailored solutions for global clients, meeting diverse project requirements with excellence and efficiency.
Proven Project Excellence
Proven track record of over 100 successful projects, spanning preclinical studies and Phase I/II/III clinical trials, including US–China dual submissions and Australian regulatory filings.
Regulatory Compliance Assurance
A robust GMP-aligned quality system with standardized SOPs, fully compliant with global regulatory guidelines across the entire product lifecycle.
Expert Team Support
Powered by industry-leading scientists and cross-functional experts, our team delivers CRDMO projects with speed, precision, and deep technical insight.