Celonic AG

Celonic Group is a privately owned CDMO with two state-of-the-art sites located at Basel (headquarters), Switzerland and Heidelberg, Germany. Providing comprehensive GMP development and manufacturing services for New Biological Entities (NBEs) and Biosimilars, worldwide, and Cell Therapy & Gene associated services worldwide. Celonic’s services include the development of cell lines, production processes, as well as non-GMP and GMP manufacturing of biopharmaceutical drug substances and drug product. To complement their services with cell line development, Celonic uses its proprietary CHOvolution™ cell line technology and the human cell line GEX® for your easy or difficult target. Being part of the JRS Pharma family, Celonic is a strong believer in creating win-win value propositions for the clients, mitigating risks by mutually-beneficial business models. Celonic is ambitious, driven by the courage to think big and the commitment to get it done. Celonic services covered: 2 INDUSTRY LEADING CELL EXPRESSION PLATFORMS: CHOvolution™: - Powered by Celonic's proprietary SEFEX™ technology - Cell line based on CHO-K1 (non-genetically modified CHO) - Cell line adapted to serum-free EMA and FDA compliant media - Simplified licensing model (no royalties from sales) - High productivity (>7 g/l for mABs) GEX®: - Human cells for fully-human glycosylation - Optimized for complex and sophisticated biopharmaceutical products - Stable product quality over full run-time for R&D and/or GMP - High productivity (up to 22g/l bioreactor volume for mAbs ) PROCESS DEVELOPMENT: - State-of-art USP and DSP development - Cutting-edge, in-house, and high throughput bioanalytics - Robust and scalable BIOMANUFACTURING CAPACITIES: - Two facilities (Germany and Basel) - Up to 2,000 L capacity batches in GMP and R&D setup - In-house analytics - Swissmedic GMP certified - 20 years of optimizing perfusion technique with >100 GMP batches FILL & FINISH: - Up to 1,250 vials/batch -Semi-automatic aseptic filling of liquids - > 300 Fill & Finish campaigns - Labeling packaging and storage of clinical test samples - Compliance with FDA & EMA standards NEW BIOLOGICAL ENTITIES : Celonic offers comprehensive approaches to enable clients to achieve commercial success, with a proven track record of developing breakthrough biologics and delivering GMP batches of ex. mABs, Growth Hormones, Fusion Proteins, and Blood Factors. BIOSIMILARS : Celonic offers ready-to-go Biosimilars (cell lines and cell pools—comprehensive analytics methods, comparability data, and development process) shaped on co-development and co-investment of next wave Biosimilars. EMPATHIE - EFFICIENCY - EXCELLENCE That's Celonic. Learn more about us.