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Biosimilars Adalimumab

Adalimumab (Humira ®) - GMP Analysis, Comparability and Consistency Studies

Adalimumab (Humira ®) is a monoclonal antibody used in the treatment e.g. of Rheumatoid arthritis, Psoriatic arthritis, or Crohn’s disease. Humira was the third TNF-α inhibitor on the market, but the first fully human antibody directed towards this target.

Adalimumab, as a typical IgG1 antibody, is comprised of a tetramer of two heavy and two light chains with one N-glycosylation site per heavy chain.

The extended patent expires end of 2016 and already many companies are developing biosimilar versions of Humira.

We have long-standing experience in the analysis of different variants of Humira originators and biosimilars.

To support the analytical development of Humira biosimilars or biobetters, Protagen has set up an analysis program in accordance with ICH Q6B guidelines, including method setup, validation of customer-specific methods, and release testing. This package includes protein quantification, characterizing the protein primary structure, analysis of N- glycosylation and protein modifications.

Specific BioAssay provided by our strategic partner Charles River Biopharmaceutical Services:

  • Target: Inhibition of TNF-α signaling Assay type: Proliferation Assay, statistical analysis by 4 parameter fit or PLA

Your contact for Adalimumab at Protagen Protein Services GmbH

Martin-Blueggel 150x100px

Martin Blüggel

Chief Executive Officer (CEO)
Our business development team will be happy to assist you with your project.

Phone: +49 (0) 231 9742-6100
Email: salesproteinservices@ProtagenProteinServices.com