Monoclonal antibodies (mAb) are produced from identical immune cells against a particular antigen. These antibodies are continuously secreted by immortalized immune cells and have a single and selected specificity. They are highly specific to diseased or damaged cells. Thus, the demand for monoclonal antibodies is growing due to efficient platform-based approaches for their production, reduced possibility of cross-reaction with undesired proteins, high specificity and low risk of safety issues in clinical trials, and high regulatory approval rates as compared to polyclonal antibodies. Due to these benefits, monoclonal antibodies are used in the specific detection of proteins and genes for modulating, blocking, and inhibiting new targets. These antibodies are used for proteomics, genomics research, and drug and IVD development. They are also being used for COVID-19 pandemic-based research studies and the development of therapies for the same.
During the COVID-19 pandemic, in addition to preventive vaccines, monoclonal antibodies remained a viable therapeutic option to treat the disease and its complications. For instance, in February 2022, FDA issued an emergency use authorization for bebtelovimab manufactured by Eli Lilly and Company (U.S.) for treating mild to moderate COVID-19 in adults and certain pediatric patients over the age of 12. In May 2021, FDA approved emergency use authorization for a new monoclonal anti-SARS-CoV-2 antibody, sotrovimab, manufactured by GlaxoSmithKline plc (U.K.) and Vir Biotechnology, Inc. (U.S.). In November 2020, FDA granted emergency use authorization for bamlanivimab and the combination of casirivimab and imdevimab in outpatients with mild to moderate symptoms who are at high risk for severe COVID-19.
Monoclonal antibodies are generated using in-vitro or in vivo methods. The in vivo method includes using animals, especially mice or rats. This method leads to extreme pain for experimental animals due to injection of the primer, inflammation of the peritoneal cavity, abdominal tension, and invasive tumors. The antibodies generated from this method show reduced immunoreactivity due to contamination by biochemically identical immunoglobulins. In addition, there is a potential risk of cross-contamination by viruses, which are pathogenic to humans. The antibodies obtained in individual batches are of variable quality and can be contaminated with bio-reactive cytokines. Thus, the in-vitro production method is adopted to overcome these drawbacks.
The in-vitro production method includes static and agitated suspension, membrane-based and matrix-based cultures, and a high cell density bioreactor. In commercial production, the serum has been replaced by serum substitute and ready-to-use serum free-media as it offers higher yield and is less expensive for monoclonal antibody production. Hence, the in-vitro method for producing monoclonal bodies is the most widely used method due to its advantages over the in-vivo method.
Hence, the demand for monoclonal bodies for various applications and wide acceptance of the cell culture method for its production drive the global market. According to Meticulous Research®, the global cell culture market is expected to grow at a CAGR of 11.7% to reach $48.63 billion by 2029.
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