Merck

mRNA CDMO Services

Scientist holding mRNA vial.

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 capping methods, UTR design, codon optimization and length of poly(A)-tail
  • Production of mRNA sequences with unmodified or modified bases
  • Production of mRNA sequences up to 13,000 nucleotides in length
  • Any scale available from mg to g

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:

  • Highly reproducible process yielding mRNA with a homogeneous poly(A)-tail and high performing product
  • Use of a synthetically generated template for IVT, no trailing or truncated products, no carryover of host DNA
  • A significantly lower requirement (≈ 10,000x) of plasmid DNA compared to conventional mRNA manufacturing processes

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



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