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.
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:
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:
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
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.
Our experts can help you navigate key considerations for designing, building, and operating an agile and flexible GMP biomanufacturing facility successfully, safely, and profitably.
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.
LNP Formulation and Fill Finish
Covering all phases from pre-clinical development to commercial manufacturing for LNP formulations, including fill/finish.
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