Evaluation of physicochemical and functional similarity of a new CHO derived anti-EGFR antibody P-mAb to its reference medicinal product

• Published in: Artificial cells, nanomedicine, and biotechnology Vol. 50; no. 1; pp. 17 - 28
• Main Authors: Nandal, Jitender, Mihooliya, Kanti N., Verma, Himanshu, Kalidas, Nidhi, Ashish, Fnu, Mishra, Ravi P. N., Sahoo, Debendra K.
• Format: Journal Article
• Language: English
• Published: England Taylor & Francis 01.12.2022; Taylor & Francis Ltd; Taylor & Francis Group
• Subjects: Animals; Antibodies, Monoclonal - pharmacology; Biological products; Biosimilar Pharmaceuticals - analysis; Biosimilar Pharmaceuticals - chemistry; Biosimilar Pharmaceuticals - pharmacology; Cancer; CHO Cells; Colorectal carcinoma; Cricetinae; Epidermal growth factor; Epidermal growth factor receptors; Functional analysis; Gel electrophoresis; Growth factors; Humans; Immunoglobulin G; Monoclonal antibodies; Monoclonal antibody; MTT assay; panitumumab biosimilar; physicochemical and biological characterisation; SAXS; Scattering, Small Angle; Similarity; Sodium lauryl sulfate; Structure-function relationships; Tandem Mass Spectrometry; Therapeutic applications; X-Ray Diffraction; panitumumab biosimilar; Monoclonal antibody; physicochemical and biological characterisation; MTT assay; SAXS
• ISSN: 2169-1401; 2169-141X
• DOI: 10.1080/21691401.2022.2028284

Epidermal growth factor receptor (EGFR) is the primary target for the treatment of colorectal cancer, the third most diagnosed cancer worldwide. In recent years, regulatory changes have facilitated the approval of biosimilars aimed to bring more access to biologics to patients. However, it has also expended the requirements of non-clinical characterisation data using state-of-the-art and orthogonal methodologies to demonstrate similarity between proposed biologic and its reference medicinal product (RMP). The current study was aimed to develop a stable CHO-S cell line producing panitumumab biosimilar candidate, P-mAb, a fully human IgG2 anti-EGFR monoclonal antibody and assess its physicochemical and functional similarity with RMP, Vectibix. The single-cell clone from stably transfected CHO-S cell pools was used for the production of P-mAb. This was followed by purification and comparative physicochemical and biological characterisation of P-mAb and RMP using SDS-PAGE, LC/MS, MALDI, MS/MS, CD spectrometry, DSF, SAXS, ITF, MTT assay and binding affinity. SAXS and MST assays are being used for first time in biosimilarity analysis of therapeutic monoclonal antibody. The results of structural and functional analysis of anti-EGFR P-mAb, produced by stable CHO-S cell line revealed high similarity between P-mAb and RMP, vectibix, thus providing the scientific basis of its potential for therapeutic applications.