Downstream Processing (DSP)

Celonic exhibits the know-how and equipment for the efficient and rapid, computer aided development of purification strategies. The equipment is suited to scale up the purification into industrial scales. We provide Aekta chromatography systems, micro-, ultra- and tangential flow filtration systems as well as nanofiltration for virus removal. The generic process established by Celonic for the purification of monoclonal antibodies and fusion proteins comprises cell removal from culture broth, a concentration, protein A-capture, intermediary und polishing purification, ultra-/diafiltration and finally virus filtration. At every step, we succeed in keeping a recovery yield of higher than 95 %. In total, we are able to reach a recovery yield of more than 80 % for monoclonal antibodies and fusion proteins.

We develop for you the downscale model for virus removal validation studies and take care of the study in co-operation with specialized and accredited laboratories.

Key words: Cellonic, Contract Manufacturing Organization, Contract Analytic, Contract Research, regulatory conform, DSP, 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, pre-clinical, clinical study material, market supply manufacturing, scale-up development, stability testing, Quality Control, HPLC for biologics, Protein A HPLC, 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, biopharmaceuticals, CEMAX, SEFEX, biosimilar, biotechnology, EMA, EMEA, FDA, IgG, proof of concept, regulatory affairs, quality management, quality assurance, immune therapeutics, cancer therapeutics, pharmaco kinetic, dynamic, large scale manufacturing, 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, affinity chromatography, cleaning validation, WFI, documentation, SOP, instruction, Master Batch Record, quality management handbook, clean rooms, class C, 2-8°C, room temperature, column chromatography

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