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.

“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 (http://www.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.