therapeutic monoclonal antibodies

Antibodies play an essential role in the pharmaceutical industry, particularly in the production of vaccines and antibiotics, and also have the potential to bring in significant revenue.

A recently-released La Merie report, entitled Antibody Technology Companies 2010 , detailed that there were 34 "original therapeutic monoclonal antibodies and Fc-fusion proteins" on the market which managed to produce revenues in excess of $45.5 billion (£28 billion).

The report detailed the "unprecedented range of possibilities" presented by the development of technologies in antibody production and lead optimisation, although explained that selecting the correct technology is becoming "more difficult than ever".

Despite this there are large numbers of biotechnology drugs within the pipeline – 633 were being developed in 2008 alone, designed to target more than 100 diseases, a report by the Pharmaceutical Research and Manufacturers of America (PhRMA) identified.

These included the creation of monoclonal antibody therapies for asthma, Crohn’s disease, rheumatoid arthritis, lupus, and various cancers.

Associate Professor David Tarlinton, from the Walter and Eliza Hall Institute, explained: "B cells and antibody production are the key to the success of all currently used vaccines for immunity in humans."

Collaborating on antibody production and research

The Walter and Eliza Hall Institute, located in Melbourne, Australia, has produced more than 100 monoclonal antibodies in its inhouse facilities, for use in research into cancer, chronic inflammatory diseases and infectious diseases.

Under a recently-signed deal with BD, a technology company based in New Jersey, which will see the two organisations collaborate to discover novel targets to be used in the development of drugs and therapeutic monoclonals.

BD will make annual payments to the institute, as well as any royalties earned from the sale of antibodies. In return it will be the first company to be offered the chance to commercialise any antibodies produced by the institute.

Dr. James Dromey, business development manager for the institute, said it is the first contract that the organisation has signed to commercialise its reagents.

"The institute's strategic research interests align well with those of BD, particularly in key areas such as cancer, programmed cell death (apoptosis), stem cells and immunology," he added.

Challenges for antibody production

Some of the most popular monoclonal antibodies, such as Avastin, Herceptin, Rituxan, Humira, and Remicade, demand high production levels, amounting up to 1,197 kg per year, according to Gunter Jagschies, senior research and development manager at GE Healthcare, who was quoted in a recent article for GEN.

Speaking at a Biological Production Forum, Jagschies explained that there are likely to be a small number of antibodies in the future which require such large scale production, however those designed for the treatment of Alzheimer's Disease and osteoporosis 'may be candidates for large-scale production'.

This combined with the increase in titers could lead to issues with over capacity for those with large-scale antibody production facilities.

"We will see people closing down, mothballing, or selling off their facilities. No one is going to build these dinosaurs of capacity," he was quoted by the news provider as saying.

Jagschies predicted that focus on increasing the titer to boost economic return will cease.

Development is also taking place on substances which will allow for the replacement of antibodies in certain situations.

BioCurex, Inc recently filed a patent for a synthetic peptide which can be used to replace the antibody in the company's RECAF cancer test, while also "allowing for many other applications that cannot be performed with an antibody".

Dr. Ricardo Moro-Vidal, president and chief executive officer of the company, said: "The product of several years of work, this patent will improve everything we do while reducing the complexity and cost of the process.

"This peptide opens a wide range of possibilities for delivering killing agents to cancer cells."

The production sequence for the peptide is much short sequence than that for an antibody and can be automated, it is also much easier to modify the peptide.

therapeutic monoclonal antibodies

Unprecedented Possibilities and Capabilities for Antibody Production

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