Integration of NMR Spectroscopy in an Analytical Workflow to Evaluate the Effects of Oxidative Stress on Abituzumab: Beyond the Fingerprint of mAbs

Author:

Cerofolini Linda123,Ravera Enrico1234ORCID,Fischer Christian5,Trovato Andrea6,Sacco Francesca1,Palinsky Wolf7,Angiuoni Gabriella6,Fragai Marco123ORCID,Baroni Fabio6ORCID

Affiliation:

1. Magnetic Resonance Centre (CERM), University of Florence, Via L. Sacconi 6, 50019 Sesto Fiorentino, Italy

2. Consorzio Interuniversitario Risonanze Magnetiche di Metalloproteine (CIRMMP), Via L. Sacconi 6, 50019 Sesto Fiorentino, Italy

3. Department of Chemistry “Ugo Schiff”, University of Florence, Via della Lastruccia 3, 50019 Sesto Fiorentino, Italy

4. Florence Data Science, University of Florence, Viale Morgagni 59, 50134 Florence, Italy

5. Bruker BioSpin GmbH, Rudolf-Planck-Str. 23, 76275 Ettlingen, Germany

6. Analytical Development Biotech Department, Merck Serono S.p.a, an affiliate of Merck KGaA, Darmstadt, Germany, Via Luigi Einaudi 11, 00012 Guidonia, (RM), Italy

7. Biotech Development Programme, Merck Biopharma, an affiliate of Merck KgaA, Darmstadt, Germany, Zone Industrielle de l’Ouriettaz, 1170 Aubonne, Switzerland

Funder

European Commission

Ministero dell?Istruzione, dell?Universit? e della Ricerca

Regione Toscana

H2020 Research Infrastructures

Publisher

American Chemical Society (ACS)

Subject

Analytical Chemistry

Reference52 articles.

1. An Industry Perspective on Forced Degradation Studies of Biopharmaceuticals: Survey Outcome and Recommendations

2. EMA. ICH Q5C Stability Testing of Biotechnological/Biological Products, European Medicines Agency. https://www.ema.europa.eu/en/ich-q5c-stability-testing-biotechnologicalbiological-products. (accessed 2022-10-12).

3. Anonymous. ICH Q8 (R2) Pharmaceutical Development, European Medicines Agency. https://www.ema.europa.eu/en/ich-q8-r2-pharmaceutical-development. (accessed 2021-09-01).

4. Multivariate Analysis of Two-Dimensional 1H, 13C Methyl NMR Spectra of Monoclonal Antibody Therapeutics To Facilitate Assessment of Higher Order Structure

5. Comparative Analysis of One-Dimensional Protein Fingerprint by Line Shape Enhancement and Two-Dimensional 1H,13C Methyl NMR Methods for Characterization of the Higher Order Structure of IgG1 Monoclonal Antibodies

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