Overview
Celonic Group is a Switzerland-based biologics CDMO offering end-to-end drug substance development and manufacturing for monoclonal antibodies, bispecifics, and complex molecules. Services span cell line development, process optimization, clinical and commercial manufacturing up to 2,000L scale, with Swissmedic GMP certification. They leverage advanced technologies like perfusion bioprocessing and partner for fill-and-finish via strategic alliances.
Frequently asked questions
- What biologics does Celonic Group specialize in developing and manufacturing?
- Celonic specializes in monoclonal antibodies (mAbs), bispecifics, fusion proteins, growth hormones, blood factors, and other complex molecules using CHO-based systems like CHOvolution and GS-CHOvolution.
- What are Celonic Group's manufacturing capabilities and regulatory status?
- They offer up to 2,000L GMP and R&D scale batches in fed-batch, N-1, and full-perfusion processes at sites in Heidelberg and Basel, with Swissmedic GMP certification and support for IND/BLA/MAA filings.
- Where are Celonic Group's facilities located and what geographies do they serve?
- Facilities are in Heidelberg, Germany, and Basel, Switzerland; they partner with global biotech and biosimilar companies worldwide, including strategic alliances for fill-and-finish and ADCs.