Improvement of the Degradation Profiling of Eculizumab and Omalizumab Monoclonal Antibodies by Liquid Chromatography–Mass Spectrometry

Author:

Degterev M.,Smolov M.,Shukurov R.

Publisher

Pleiades Publishing Ltd

Subject

Analytical Chemistry

Reference41 articles.

1. Rader, R.A., Biopharma market: An inside look, Pharma Manufacturing, 2018. http://www.pharmamanufacturing.com/articles/2018/biopharma-market-an-inside-look. Accessed March 3, 2020.

2. http://lab.express-scripts.com/lab/insights/drug-options/biosimilars-in-the-us-more-approvals-but-not-access. Accessed March 5, 2020.

3. Biosimilars approved in Europe. http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe. Accessed March 9, 2020.

4. Assessment Report for Soliris, International Nonproprietary Name: Eculizumab, Procedure no. EMEA/H/C/000791/II/0050, London: European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP), March 21, 2013, EMA/CHMP/126714/2013.

5. Assessment Report for Xolair, International Nonproprietary Name: Omalizumab, Procedure no. EMEA/ H/C/606/II/18, London: European Medicines Agency, June 25, 2009, EMEA/493707/2009.

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