Comprehensive mRNA CRDMO Services
Elise Biopharma provides expert, world-class Contract Research, Development, and Manufacturing Organization (CRDMO) services tailored specifically for messenger RNA (mRNA) therapeutics and related products. Our comprehensive suite of capabilities covers every phase—from early-stage plasmid DNA manufacturing through advanced GMP-compliant mRNA production and final drug product formulation.
End-to-End mRNA Development Capabilities
Our integrated approach ensures seamless progression at every stage:
1. Plasmid DNA Manufacturing
- Microbial-Based Systems: Utilizing advanced microbial fermentation platforms optimized for plasmid DNA production.
- High-Purity Outputs: Robust plasmid isolation and purification methods to ensure high-quality DNA suitable for efficient transcription.
2. mRNA Synthesis and Transcription
- High-Yield Transcription: Optimized in vitro transcription processes designed for superior yield and mRNA integrity.
- Quality Optimization: Rigorous analytical assessments to confirm mRNA stability, purity, and proper capping and polyadenylation.
3. Lipid Nanoparticle (LNP) Formulation
- Advanced Encapsulation: State-of-the-art lipid nanoparticle production systems to ensure optimal encapsulation efficiency and stability.
- Custom Formulations: Tailored LNP formulations developed to meet specific therapeutic requirements and improve bioavailability.
4. Robust Purification and Downstream Processing
- Efficient Purification Protocols: Comprehensive downstream processes including chromatography and filtration techniques to yield highly purified mRNA-LNP complexes.
- Analytics and Stability: In-depth analytical characterization and stability testing to ensure product efficacy and shelf-life.
5. Robotic Aseptic Filling and Final Product Manufacturing
- Automated Filling Systems: Precision robotic aseptic filling technologies that guarantee sterility and consistency in drug product formulation.
- Compliance and Quality Assurance: Adherence to rigorous global regulatory standards, supported by an advanced, world-class quality management system.
Cutting-Edge GMP Manufacturing Infrastructure
Elise Biopharma’s state-of-the-art GMP facilities are designed specifically for scalable mRNA production, featuring:
- Scalable Fermentation Units: Multiple GMP-certified fermenters optimized for plasmid DNA production.
- Advanced Transcription Vessels: Dedicated transcription units designed to maximize mRNA yield and quality.
- High-Efficiency LNP Manufacturing Units: Custom-designed lipid nanoparticle formulation equipment ensuring efficient encapsulation.
- Integrated Cleanroom Suites: Modular, HEPA-filtered cleanroom environments compliant with stringent EU Grade A-D classifications.
Why Partner with Elise Biopharma for mRNA Projects?
- Specialized Expertise: Extensive experience and deep scientific expertise in mRNA technology.
- Integrated Services: Comprehensive, end-to-end solutions covering every stage from plasmid to final product.
- Regulatory Excellence: Robust quality systems that align with global regulatory compliance (FDA, EMA).
- Agility and Flexibility: Highly adaptable facilities and rapid scalability tailored specifically to your project’s unique needs.
At Elise Biopharma, our CRDMO services for mRNA therapeutics are built upon industry-leading technology, executional excellence, and a commitment to quality, providing unparalleled support to advance your innovative mRNA-based therapies and vaccines.