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Since their initial production in 1975 as mere research tools, monoclonal antibodies (Mabs) have found a range of commercial applications in medical diagnosis and therapy. Recent advances in the production of monoclonal antibody technologies has shown the way for their use as excellent therapeutic agents for a wide variety of diseases, including many types of cancers, inflammatory and autoimmune diseases, cardiovascular diseases, as well as several metabolic disorders such as diabetes.
The first generation of therapeutic antibodies, primarily derived from rodent hybridomas, proved to be less effective as they triggered severe immune response in patients known as human antiMouse antibody (HAMA) response. While this problem gave rise to humanization of mouse MAbs, the more recent development of generating fully human antibodies through the phage display method and transgenic mouse systems has proved to be the driving force for the recent upsurge of therapeutic antibodies.
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“Another major driver of the antibody industry is the limited efficacy of conventional or small molecule therapies, which offer only symptomatic short-term relief often accompanied by adverse side effects, especially in the case of several oncology and autoimmune as well as inflammatory disorders,” notes Technical Insights Research Analyst (technicalinsights.frost.com) Sangeetha Prabakar. “This is creating the need for safe and effective treatment alternatives such as Mabs that may provide effective treatments with greater specificity, efficacy, and tolerability as well as minimal side effects.”
Among the notable developments in the field of antibody technology, researchers at the Liverpool’s School of Tropical Medicine have been able to analyze the generic makeup of venom and also identify the parts that cause hemorrhage after snakebites. Through DNA technology, they have identified a gene called jararhagin that causes such hemorrhage.
When researchers injected this into the skin of mice, they generated antibodies that neutralized around 70.0 percent of the hemorrhagic activity of the viper venom. Encouraged by this, scientists now plan to develop the technique further so that mice can produce human-type antibodies that they can extract and fuse with other cells to possibly manufacture a potentially limitless supply of anti-venom.
Also, researchers at Washington University in St. Louis have developed an infection-fighting antibody against the West Nile Virus, which has emerged as a regular seasonal threat in the United States, particularly for people over 50 years of age. This antibody works similar to those produced by people whose immune systems successfully attack the virus. Consequently, researchers that have tested this antibody in mice say that its success warrants further development and testing in people affected by the West Nile virus.
While the above factors encourage the growth and demand for Mabs, market success is entirely dependent on justifying their clinical and cost benefits.
“Given the complicated technology as well as the extended period of drug development and registration, prices of these products are exceedingly high in contrast to traditional pharmaceuticals,” says Prabakar. “Hence, in addressing this issue, manufacturers are now exploring alternative methods of production such as transgenic mammals, yeast, and transgenic plants for a higher yield of products at a potentially lower cost in comparison to those obtained through the mammalian cell culture method.”
Overall, despite the numerous challenges confronting the antibody industry, revenues from the existing antibody therapeutics in the market are likely to increase significantly over the years, especially in the areas of oncology, Inflammation and autoimmune disorders.
Antibody Technology Developments, is part of the Technical Insights vertical subscription service. It identifies and analyzes emerging technologies and novel applications of existing ones in the context of antibody technology developments. Further, it endeavors to cover advances in R&D, product development, and regulatory aspects related to the applications of antibodies Being a global study, the research service categorizes the findings into those that fall within the North American, European, and Asia Pacific regions. Analyst interviews are available to the press.
Technical Insights is an international technology analysis business that produces a variety of technical news alerts, newsletters, and research services.
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