Physical Characterization of Bevacizumab Biosimilar for Metastatic Colorectal Cancer

Abstract

Metastatic colorectal cancer (mCRC) reprents an advanced form of colorectal cancer, characterized by the spread of tumor cells to distant organs. Recent studies highlight Fusobacterium nucleatum’s role in tumor progression, immune syaytem modulation, and metastasis. Bevacizumab, a monoclonal antibody that targets vascular endothelial growth factor (VEGF), is commonly used to inhibit angiogenesis in metastatic colorectal cancer. This study centers on the in vitro development, physicochemical characterization, functional assessment, and regulatory aspects of a bevacizumab biosimilar. To verify structural integrity and post translationsal modifications, advanced analytical methods including mass spectrometry, LC-MS, peptide mapping, SEC-HPLC, and ion exchange chromatography were used. Functional bioassays showed that VEGF was effectively neutrilized. In addition, gene preparation, vector construction, CHO cell line development, and fed-batch production were carried out to generate the biosimilar. The study also identifies major regulatory hurdles in approving biosimilars. The findings confirm that the developed biosimilar has similar structural and functional characteristics to the reference product. This centres specifically on a pharmaceutical research, so it includes that examine drug quality, structure and comparability.