Daniela Braun
Senior Director Project Mangement at Celonic Group
Last Updated:
August 01, 2020
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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...
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.

55 Eulerstrasse, Basel, Basel-Stadt, Switzerland, 4051

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+41 61 564 91 50

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fill & finish, fedbatch, cell amp gene therapy, biosimilars, nbe, process & analytic development, outlicensing of developed biosimilar cell lines, biosimilar antibody development, contract development & manufacturing, cell line development, gmp manufacturing up 1000l, gmp manufacturing at 1000l scale, perfusion, cell gene therapy, biotechnology

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