Merck

mRNA CDMO Services

AmpTec™ CUSTOM mRNA MANUFACTURING

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.

OUR CUSTOM mRNA CDMO SERVICES

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:

  • Production of mRNA sequences based on customer provided sequences
  • Custom tailored services provided for mRNA template design, including UTR design, codon optimization and length of poly(A)-tail
  • Production of mRNA capped with ARCA (Cap 0) or Vaccinia (Cap 1)
  • Additionally, we can provide mRNA capped using TriLink Biotechnologies LLC. CleanCap® (Cap 1)*
  • Production of mRNA sequences with unmodified or modified bases
  • Production of mRNA sequences from 2,000 to 9,000 nucleotides, longer upon request
  • Any scale available from mg to g


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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.