GenScript, a global leader in life science research tools and services support, has expanded its mRNA synthesis and formulation capabilities with the launch of a GMP-like mRNA manufacturing service, designed specifically to support preclinical studies and IND-enabling research. This new offering is expected to fill a critical gap for early-stage biotech and pharmaceutical companies that require fast delivery and cost effective high-quality regulatory-aware material for preclinical and IND (investigational new drug) studies.
A Scalable Alternative for Preclinical Teams
Fueled by the success of mRNA vaccines and the broader interest in RNA therapeutics for oncology, gene editing, cell therapy, and protein replacement therapies, the demand for high quality and fast delivery of customized mRNA in drug development has increased sharply over the past five years. However, many early-stage biotech companies face significant barriers in moving from research-grade to GMP materials for safety, toxicity, and early clinical studies.
GenScript’s GMP-like mRNA service provides a strategic solution—bridging the gap between discovery and clinical readiness. Manufactured in ISO 7-classified cleanroom environments, the service adheres to key quality and documentation principles while remaining cost-efficient and timeline-sensitive.
“Our GMP-like service was designed with flexibility in mind,” said Dr. Fengmei Pi , Head of mRNA Product Development and Manufacturing at GenScript. “Customers are seeking rapid delivery of high-purity, functional mRNA to generate preclinical data, validate delivery systems, and perform initial toxicology studies. We have optimized our platform to deliver exactly that—without compromising on quality or regulatory alignment.”
Technical Highlights and Workflow
The GMP-like service is based on GenScript’s established mRNA production platform, featuring:
- Proprietary Codon Optimization Tool designed for mRNA
- Plasmid DNA template synthesis and linearization
- IVT reaction and purification optimization for mRNA, circRNA, and saRNA
- Patented GenCapTM mRNA capping technology
- Phase-appropriate documentation and technical support
Each project is supported by a tailored quality summary report and traceability documentation. The final deliverables are suitable for IND-enabling experiments, including toxicology, biodistribution, and PK/PD analysis.
Turnaround time for standard project deliverables at GenScript can be as fast as 7 weeks, utilizing GenScript’s optimized GenCapTM co-transcriptional capping platform technology and well established quality control. This enables preclinical teams to quickly transition from screening & discovery phase to candidate development phase. This streamlined process enables mRNA researchers to focus their resources in IND-enabling studies while deferring the cost and compliance obligations of full GMP.
Addressing a Common Development Bottleneck
Full GMP manufacturing can take six to eight months or longer and requires substantial capital investment – often more than what’s available to secure an initial lead candidate for further development. For startups and smaller pharmaceutical organizations still evaluating therapeutic concepts or preparing regulatory submissions, these timelines are often prohibitive.
“Many customers are navigating uncertainty—they need to test multiple constructs, screen delivery vehicles, and conduct dose-ranging studies before selecting a clinical candidate. Additionally, large-scale process validation studies are required before making significant investments to file a drug application” explained Dr. Cedric Wu, Senior Vice President, R&D at GenScript. “GMP-like mRNA services fill the gap between research-grade and full GMP products, enabling researchers to conduct preclinical studies and prepare IND applications quickly and cost-effectively.”
This flexibility is especially appealing to emerging biotech companies, academic medical centers, and international R&D teams developing vaccines, cancer immunotherapies, or mRNA-based protein delivery systems in the early stages of research.
Market Expansion and Industry Reception
This launch comes amid increasing demand for RNA manufacturing capacity, particularly in North America and Europe. GenScript’s service expansion is expected to support hundreds of mRNA programs globally over the next two years. Early adopters have already cited significant benefits, including accelerated timelines, lower upfront costs, and reduced manufacturing complexity for their phase-appropriate needs.
By advancing mRNA and LNP technologies, GenScript is addressing key challenges in stability, targeted delivery, and immune modulation. Innovations in LNP engineering are enabling enhanced T cell targeting, liver cell prime editing, and antibody generation in murine models. These breakthroughs are paving the way for transformative therapies in oncology, genetic disorders, and complex diseases, empowering drug developers to advance from discovery to clinic with greater speed and precision.
Learn more about GenScript’s GMP-like mRNA service