mRNA CDMO Services

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KEY FEATURES

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:

Debottleneck pDNA Procurement

• PCR based mRNA manufacturing requires ~10.000 fold less pDNA compared to conventional linearization approach

Time and Cost Savings

• No Master Cell Banking establishment required saving months, only pDNA according to GMP principles necessary

Flexibility

• Highly adaptable in vitro mRNA template generation, poly(A)-tail template introduction during PCR-step

Reproducibility

• Consistent reproducible results from lengths of 200 to 9.000 nucleotides, longer upon request

Quality

• Highly homogenous in vitro generation template for IVT synthesized with high fidelity polymerases, no trailing or truncated side products

Purity

• Cell free in vitro process, mitigating risks of microbial DNA, microbial protein, and endotoxins carryover

QUALITY IS OUR FOCUS

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:

• CDMO experience with manufacture of IVT-RNAs since 1998
• Manufacturing in compliance with ISO 13485 since 2010

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.