Protected: mRNA Test

Protected: mRNA – Custom development and GMP production

Synthetic mRNA manufactured using in vitro transcription (IVT) represents a new class of drugs with applications in infectious diseases, cancer, and regenerative medicine. Leveraging over two decades of experience in biotherapeutics development and GMP manufacturing, CELONIC now offers expertise and capabilities for GMP-compliant process development and the scalable manufacture of mRNA drug substance (DS) for therapeutics and vaccines.

In vitro-transcribed mRNA can be engineered to transiently express proteins-of-interest within cells. Over the years, multiple technologies have been developed to overcome the inherent challenges of this drug class (e.g. delivery, immunogenicity and translational efficiency of synthetic mRNAs). As more mRNA candidates enter the development pipeline, there is an increasing demand for custom, high-quality, scalable GMP mRNA production capabilities.

NUCLEIC ACID SEQUENCE TO mRNA DS

CELONIC’s mRNA development and manufacturing services rely on its in-depth expertise in process development as well as its newly established facilities for GMP production of mRNA therapeutics and vaccines. CELONIC’s dedicated mRNA team is well-positioned to transfer, develop and scale-up its client’s project at any clinical development phase.

CELONIC’s mRNA capabilities include:

  • In-house USP and DSP process development and
  • Leading-edge analytics suite for testing and release
  • Pre-clinical through to commercial manufacturing
Protected: mRNA Test

IN-HOUSE ANALYTICAL SOLUTIONS FOR mRNA

Using state-of-the-art technology and instrumentation for mRNA characterization, CELONIC provides custom analytical method development, specific to the client’s target molecule. CELONIC’s analytical capabilities ensure high quality, consistency and reduced timelines throughout development, GMP testing and release.

Our analytical capabilities include:

  • Content and identity using fluorometric assays, qPCR, mass spectrometry and fragment analysis
  • Purity assessment and characterization of process-related impurities utilizes fluorescence assays, quantitative and qualitative mass-spectrometry as well as gel electrophoresis.

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We understand what it takes to bring breakthrough mRNA therapies to patients in need.

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