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Celonic launches stand-alone GMP analytics portfolio

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Challenging positions in upstream processing

Celonic – Your Partner for Mammalian Cell Culture Technology and GMP Analytics

Celonic is a privately founded company that maintains a GMP facility in Basel, Switzerland, and analytical laboratories in Juelich, Germany. It has an expertise in the field of cell biology and inflammatory/autoimmune disorders. Our services in the area of Contract Manufacturing and Contract Analysis is offered by a team with a large number of scientific experts, well trained GMP and GLP personnel, state of the art equipped laboratories and a strong focus on quality management and documentation. Celonic provides several biopharmaceutical companies worldwide with cell-line development, process development, GMP production and GMP/GLP (GCP) analytical services.

A well trained team of scientists, GLP-/GMP-compliant laboratories and a broad pattern of validated methods and qualified equipment are the basis of biopharmaceutical services focusing on preclinical and clinical R&D, biopharmaceutical manufacturing and testing as well as diagnostics in clinical studies. Celonic - your first choice CMO!

Celonic – The number one choice in Contract Manufacturing and Contract Analytics for Biologicals!

Key words: Cellonic, Contract Manufacturing Organization, Contract Analytic, Contract Research, Cell line development, stable high producer cell line, high producing cell line, regulatory conform, expression optimization, culture process optimization, USP, DSP, upstream process development, downstream process development, GMP, cGMP, non-GMP, GMP-like, GLP, GCP, manufacturing, GMP manufacturing license, animal tox study material, toxicology, biologic material, recombinant monoclonal antibody, recombinant protein, mammalian cell lines, cells, CHO, fast track cell line development, pre-clinical, clinical study material, market supply manufacturing, scale-up development, stainless steel stirred tank bioreactors, wave bioreactor, 1000 L scale, 300 L scale, serum free media, chemically defined media, cell culture media, transfection in serum free media, vector construction, mini pools, stability testing, MCB, Master Cell Bank, WCB, Working Cell Bank, PSB, Primary Seed Bank, research cell bank, Quality Control, HPLC for biologics, Protein A HPLC, parallel culturing systems, virus inactivation, validation batches, lots, downscale model, virus validation study, reference standard, pilot production, Drug Substance, Drug Product, specific Host Cell Protein assay, HCP, quality strategy, GLP-analytics, CHO K1, DG44, DHFR, biopharmaceuticals, HELA, HEK293, animal cells, CEMAX, SEFEX, biosimilar, biotechnology, EMA, EMEA, FDA, IgG, proof of concept, cultivation, suspension, adherent, cell growth, regulatory affairs, quality management, quality assurance, Wave bioreactors, immune therapeutics, cancer therapeutics, pharmaco kinetic, dynamic, large scale manufacturing, feeding strategy, dissolved oxygen, glucose level, human like glycosylation structure, glycol-optimisation, affinity, dimerization, aggregates formation, Q-sepharose, Heparin sepharose, ion exchange, anionic cationic chromatography, dialysis, tangential flow filtration, TFF, ultra-filtration, nano-filtration, virus-filtration, sterile filtration, Bioburden reduction, API formulation, formulation buffer study, amplification, cloning, sub-cloning, shaker flasks, spinner culture, 6-well-culture, fed-batch, perfusion, disposable bioreactors, affinity chromatography, cleaning validation, WFI, harvest, primary clone, documentation, SOP, instruction, Master Batch Record, quality management handbook, clean rooms, class C, 2-8°C, room temperature, column chromatography