mRNA & LNP CTDMO Services
Our mRNA & LNP offering
mRNA technology uses non-viral delivery systems and offers a great deal of versatility. As naked mRNA is unstable, drug delivery systems, such as lipid nanoparticles, are necessary to deliver mRNA to target cells. Our integrated CDMO capabilities include the development and manufacture of custom mRNAs, synthetic lipids, and the formulation, fill and finish of lipid nanoparticles (LNP). We are committed to direct and flexible customer interactions with life science industries and academic research institutions around the world, including technical support. Our integrated capabilities significantly decrease supply chain complexity and enhance speed-to-market for our customers which in turn will help advance life-enhancing therapeutics for patients.
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mRNA CONTRACT DEVELOPMENT AND MANUFACTURING SERVICES
Our integrated CDMO capabilities include the development and manufacture of custom mRNAs. With our proven AmpTec™ workflow, mRNA manufacturing is highly reproducible. Key features include:
- Production of fully customizable sequences, up to 13,000 nucleotides
- A significantly lower requirement (~10,000x) for plasmid DNA compared to standard mRNA manufacturing processes
- Highly reproducible process yielding mRNA with a homogeneous poly A tail and high-performing product
SYNTHETIC LIPIDS FOR PHARMACEUTICAL APPLICATIONS
We are highly specialized in synthesizing top-quality, GMP lipids for pharmaceutical applications and gene therapy, focusing on tailored manufacturing to meet your specific needs. We also offer a standard portfolio with optimized stability, solubility, and handling characteristics. If lipid blends are needed, we can provide lyophilization and spray drying.
Benefits of our lipids include:
- Support in every phase of development and marketing
- cGMPs and site standards that follow ICH Q7 concepts
- Consistent, high product quality from grams to tons
- Stability studies and analytical method development and validation
- Regulatory expertise and counsel from a dedicated team
- An excellent track record of customer and FDA audits
LIPID NANOPARTICLE FORMULATION & Fill & Finish
We provide a full-service LNP CDMO covering all phases from pre-clinical development to commercial manufacturing for LNP formulations, including fill/finish.
Preclinical: formulation and process development, analytical method development
Clinical: Tech transfer, process scale-up, GMP manufacturing, CMC support
Commercial: GMP manufacturing, aseptic fill, QC, packaging and inspection, supply chain
- Key benefits to our customers: Proven track record of manufacturing commercial drug products incl. Covid-19 vaccine
- End-to-end service from API to manufacturing and fill & finish
- In-house transfer to GMP
- Expertise in process optimization from small scale to manufacturing
Process Development
Leveraging our in-house expertise, we offer a complete range of process development (PD) services to improve the yield and quality of your mRNA and LNP.
Facility Design Services
Our experts can help you navigate key considerations for designing, building, and operating an agile and flexible GMP biomanufacturing facility successfully, safely, and profitably.
Process Development Services
You can rely on us for flexible, best-in-class process development and manufacturing templates.
Manufacturing
With more than 20 years of experience providing critical components for mRNA therapies, we now further expand to include LNP formulation and fill/finish capabilities to form the most comprehensive portfolio of products and services essential for mRNA vaccines and therapeutics development.
mRNA Manufacturing
With our proven PCR-based workflow, mRNA manufacturing is highly reproducible and the final product has excellent properties.
LNP Formulation and Fill Finish
Covering all phases from pre-clinical development to commercial manufacturing for LNP formulations, including fill/finish.
Related Resources
White Paper: Successful Drug Development with Synthetic Lipids - Critical Aspects and Strategies
White Paper: Strategies for Successful Formulation Development of Lipid-Based RNA Delivery and Vaccines
Article: Manufacturing Strategies for mRNA Vaccines and Therapeutics
Article: Realizing the Promise of RNA Therapies with Lipid Nanoparticle Delivery
LNP formulation and fill finish
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