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

CELONIC utilizes advanced instrumentation, multi-scale bioreactors and leading-edge technologies for process development, production and purification of mRNA candidates.

Our services include:

• Lab-scale grade plasmid generation & optimization for efficient in vitro transcription
• IVT optimization – high purity and yield
• Capping: co- or post-transcriptional capping and cap analogs
• mRNA purification: alcohol (precipitation) or HPLC-based

COMPLIANT GMP MANUFACTURING

Leveraging its more than two decades of experience in the GMP manufacture of complex biomolecules, CELONIC provides tailored solutions to its clients.

Our expertise and capabilities include:

• Regulatory compliance: CELONIC’s robust Quality Control processes, Quality Systems and highly experienced teams ensure strict compliance with regulatory requirements for emerging drug classes
• Optimal flexibility; CELONIC offers tailored business models, flexible suite ownership and rapid facility expansion using modular technology
• Two state-of-the-art GMP manufacturing facilities with 115,000 ft² of GMP clinical and commercial manufacturing area in Heidelberg, Germany and more than 90,000 ft² of additional GMP space in Stein, Switzerland

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.

LET’S GET STARTED

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

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