Testing
Celonic launches stand-alone GMP analytics portfolio

Challenging positions in upstream processing
Why Celonic?
With a strong personal background in core drug development, Celonic has established the full range of services to accompany the production of biopharmaceuticals. What counts most, is that we offer excellent quality and customised solutions at reasonable prices. Starting at cell line development and upstream processing, Celonic is a competent and reliable partner up to the production of market demands. We constantly broaden our service offerings by implementing effective, approved and reliable technologies which are offered license free with our service offerings.
Our team is long-term experienced in development and production of biopharmaceutical proteins. Fulfilling all necessary and voluntary regulatory standards is part of our philosophy.
Are you stuck in the communication with regulatory authorities concerning drug approval? We are glad to accompany you during CMC (chemistry, manufacturing and control). Our team for internal clinical development projects is available for customer support and consultation.
Celonic – your one-stop-shop in biopharmaceutical development, production and analytics.
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







