Raman Spectroscopy to Monitor Post-Translational Modifications and Degradation in Monoclonal Antibody Therapeutics

Author:

McAvan Bethan S.1,Bowsher Leo A.2,Powell Thomas2ORCID,O’Hara John F.2,Spitali Mariangela2,Goodacre Royston3ORCID,Doig Andrew J.4ORCID

Affiliation:

1. School of Chemistry, Manchester Institute of Biotechnology, University of Manchester, 131 Princess Street, Manchester M1 7DN, United Kingdom

2. UCB Celltech, UCB Pharma, Limited, 208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom

3. Department of Biochemistry, Institute of Integrative Biology, University of Liverpool, Biosciences Building, Crown Street, Liverpool L69 7ZB, United Kingdom

4. Division of Neuroscience and Experimental Psychology, School of Biological Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester M13 9PT, United Kingdom

Funder

UCB

Biotechnology and Biological Sciences Research Council

Publisher

American Chemical Society (ACS)

Subject

Analytical Chemistry

Reference37 articles.

1. FDA, Guidance for Industry PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, 2004, www.fda.gov/regulatory-information/search-fda-guidance-documents/pat-framework-innovative-pharmaceutical-development-manufacturing-and-quality-assurance (accessed July 16, 2020).

2. European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP) Guideline on similar biological medicinal products containing monoclonal antibodies-nonclinical and clinical issues, (2012). www.ema.europa.eu (accessed June 17, 2019).

3. Raman spectroscopy as a process analytical technology for pharmaceutical manufacturing and bioprocessing

4. In-line Raman spectroscopic monitoring and feedback control of a continuous twin-screw pharmaceutical powder blending and tableting process

5. Real-time monitoring of antibody glycosylation site occupancy by in situ Raman spectroscopy during bioreactor CHO cell cultures

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