Our integrated CDMO capabilities include the development and manufacture of custom mRNAs. We are committed to direct and flexible customer interactions with life science industries and academic research institutions around the world, including technical support. Our key feature is the proven PCR-based workflow making mRNA manufacturing highly reproducible, leading to excellent properties of the final AmpTec™ mRNA product.
We specialize in the production of fully customized functional mRNAs and provide full technical support from project design, sequence optimization to data for investigative new drug (IND) dossiers. Our custom AmpTec™ mRNA product manufacturing services include:
With our proven PCR-based workflow, mRNA manufacturing is highly reproducible, and the final product has excellent properties. Key features of our custom AmpTec™ mRNA product manufacturing workflow include:
We have a proven track record as CDMO for providing quality mRNAs to our customers. Our AmpTec™ products meet the requirements of the finest international standards:
Implementation of cGMP FDA 21 CFR Part 210 and ICH Q7 (section 19: APIs for use in clinical trials) requirements in advanced state
*CleanCap® mRNA material is produced through the use of U.S. Patent 10,519,189, U.S. Patent 10,494,399, U.S. Patent 10,913,768 and related applications in the US and other countries.
Merck KGaA Darmstadt, Germany and its subsidiaries have been granted a license by TriLink Biotechnologies LLC to manufacture CleanCap® mRNA using CleanCap® Reagent for research purposes, including clinical trials.
Flyer: mRNA CDMO services and raw materials for lipid nanoparticle formulation
Flyer: Lipids for pharmaceutical application
Workflow: mRNA Manufacturing & Formulation Products. Services. Expertise.
Webinar: Make it Right - Best Practices for mRNA Manufacturing
Webinar: Key to Successful Formulation Development for Lipid Based RNA Delivery and Vaccines
Webinar: Unlocking the Potential of mRNA Vaccines and Therapeutics
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