Fast Track Process Development

Celonic possesses comprehensive experience in the cultivation of eukaryotic cells like CHO-, Hybridoma- (NS0, NS1) as well as human (HEK293) cell lines typically used for the production of recombinant therapeutic proteins.

We offer a complete range of preclinical development:

• development of regulatory compliant production cell lines
• GMP cell banking (MCB / WCB)
  
• process development in the area of fermentation (USP)
• establishing of efficient purification processes (DSP)
  
• implementation and performing of assays for quality control
• scale up of developed process
• GMP production (1'000 liters wave, 1'000 liters stirred vessel, single use)

Let's talk about your project!

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, glycosylation 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

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