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.
To find out more about Celonic Group contact Oliver Masson, Senior Account Manager (CDMO, Large Molecule) at Mantell Associates, on +44 (0)20 3778 0990 or oliver.masson@mantellassociates.com.