Pharmaceutical Firms Make Immunogenicity a Priority

Interest in immunogenicity is growing among pharmaceutical companies. The concept – which measures the potential for a drug to trigger the body's immune system – has been prominent for several years, but is only now getting the attention it perhaps deserves. It certainly sounds like something that could benefit drugs producers, so why has the issue only just become a priority for them?

New regulatory guidelines have made it vital for companies on both sides of the Atlantic to fully prove that their latest products will not cause negative immune reactions. It is believed such incidences would end up costing major amounts of money as businesses seek to rectify the problems. The latest batch of regulations expected this year is likely to further boost interest in the issue.

In addition, companies have previously chosen to focus on other tests to check that their latest drugs comply with standards. A number of checks have been used in drug development over the years, particularly those carried out to measure the toxicity of products.

While a strong case can be presented for the use of immunogenicity within the creation of new medications, what impact has the concept had on studies and checks that have taken place in the pharmaceutical industry recently?

At the end of last year, research was published that highlighted how immunogenicity testing can benefit the sector. Published in the Journal of the American Medical Association, the study, by researchers at the University of Melbourne, considered the effectiveness of giving children aged nine years or under two doses of a vaccine to protect them from H1N1 influenza. The team assessed the safety of the double dose in 370 healthy infants aged between six months and nine years old in Australia, who were randomly placed into groups and then received two injections 21 days apart in doses of either 15 micrograms or 30 micrograms.
The authors said: "Our findings suggest that a single 15-microgram dose vaccine regimen may be effective and well tolerated in children, and may have positive implications for disease protection and reduced transmission of pandemic H1N1 in the wider population."

While the study into the immunogenicity of the vaccine could have a major impact on how stocks of the medication are used, the authors added that definitive data would be needed before making changes to how the drugs are administered.

The immunogenicity of H1N1 vaccines appears to be a big issue at present. It was recently confirmed that medical firm Bharat Biotech is to begin tests on the issue in its cell culture-based drug designed to protect people from the illness. A phase I clinical trial has been started on the product, which is the first of its kind to be created in India, and is expected to last for around six weeks.

Dr Krishna Ella, chairman and managing director of Bharat Biotech International, said the company was very excited about testing the drug. She added: "In pre-clinical evaluation the vaccine candidate triggered a beneficial immune response."

Immunogenicity is not being solely devoted to the world of H1N1 vaccines. In fact, a wide range of companies have now added such testing into their pre-clinical and clinical research phases in an effort to meet the strict criteria being used by industry authorities. There have even been suggestions that some already-established drugs could be given retroactive testing in order to meet standards that have only emerged recently.

Immunogenicity is likely to move forward in the future too, with predictive testing one area that is attracting a lot of interest. It is hoped the ability to forecast how well products would do in testing would give pharmaceutical firms the opportunity to make decisions without committing to certain levels of investment. In addition, assay development is also a growing area of interest for economic reasons, as improvements will undoubtedly help firms to cut costs.

Both of the concepts mean that while immunogenicity may not have been a big issue in the past, it is certainly looking forward to a brighter future and a larger profile in the world of pharmaceuticals. For many companies, the use of the tests could bring major financial benefits, as well as ensuring that their new products comply with the demands of authorities.