mRNA CUSTOM DEVELOPMENT AND GMP PRODUCTION
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.
Synthetic mRNA manufactured using in vitro transcription (IVT) represents a new class of drugs with applications in infectious diseases, cancer, and regenerative medicine.
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.
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. Our 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