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Eye on Bio
August 29, 2012   
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Work to develop two types of manmade insulin and a package of vaccines is under way at the Institute of Biotechnology and Antibiotics (IBA) in Warsaw. The institute is carrying out the project in a scientific consortium with the University of Gdańsk and the Polish Academy of Sciences’ Institute of Biochemistry and Biophysics under the European Union’s Innovative Economy Operational Program.

The institute’s director, Piotr Borowicz, Ph.D., talks to Karolina Olszewska.

Your project has an impressive co-financing budget of zl.90 million. Is this amount enough to make sure that innovative pharmaceuticals and vaccines will hit the market?

The development of drugs using biotechnology requires huge spending because it is a broad and strictly regulated area. Our project, which aims to develop a range of innovative biopharmaceuticals for both people and animals, is a seven-year applied project. It is not our goal to make scientific discoveries worthy of a Nobel Prize. Instead, we want to develop specific market products for the healthcare sector—insulin analogs with a modified structure and effect, and non-injectable avian influenza vaccines.

Before it is launched on the market, a drug needs to be registered to make sure it is safe and effective. This involves many tests and documents describing the structure of the protein involved, its toxicity and contamination limits. Seven years is not even long enough to complete all pre-clinical studies.

How are biopharmaceuticals different from conventional drugs?

Apart from small chemical molecules, our environment contains very large biological molecules—proteins and peptides—which have a complex spatial structure and bond with each other in different ways. This is what biopharmaceuticals—the vaccines and insulin analogs—are like. Their complexity means that they are much more expensive than drugs composed of small chemical molecules.

We know how to make biologically active proteins that work increasingly well at the cellular level in the body. This enables the development of new forms of pharmaceuticals with enhanced properties for use in new therapeutic areas. Many biopharmaceuticals are more effective than natural proteins produced by the human body. And we are finding new therapeutic applications for them. Such drugs have a high position on the global market.

Insulin analogs with a modified effect are one example. They imitate the insulin produced by the human body but their effect in diabetes treatment is enhanced. The project is a follow-up to research conducted by the IBA on biopharmaceutical technologies, studies that began with applying the IBA’s own method for producing Gensulin, the recombined human insulin which was Poland’s first drug produced using biotechnology.

In what way are your pharmaceuticals innovative?

We are developing two types of insulin analogs—one with a long-term effect and the other with a short-term effect. In order to better understand how they work, it is worth learning about the natural mechanism they imitate. Glucose is the basic fuel for every cell and it is necessary to support life functions. Carried by blood, it circulates in the human body and comes into contact with each cell. However, it is unable to enter a cell on its own. Insulin is needed for glucose to penetrate into the cell.

It is very harmful for the patient if their blood glucose levels are either too high or too low. In the course of evolution, the human body has developed a mechanism that regulates blood glucose concentrations. During a meal, when the level of glucose grows sharply, the pancreas immediately produces the right amount of insulin. But in people suffering from diabetes this mechanism does not work properly and has to be imitated by using fast-acting insulin analogs. The patient takes such an analog when starting a meal. The substance is absorbed very quickly by the body and the process imitates the secretion of insulin by the pancreas of a healthy person.

In turn, insulin analogs with a long-term effect are designed to ensure that the patient maintains a natural and steady blood glucose level at night and between meals. At night, the level of glucose in the blood is steady and low because we do not eat. But the brain works all the time and energy is needed to support life processes. This is why glucose still needs to be able to penetrate into cells, though in small quantities. The body also needs to continue producing insulin—at a slow and steady pace, without highs and lows. Ensuring this is even more difficult and scientists are still looking for an ideal solution. At present insulin analogs with a long-term effect are injected once a day. We are working to develop an analog that the patient will be able to take only once a week.

What about the vaccines? Is avian flu still a real danger?

Today, avian flu seems to be of little danger to people, but researchers should try to foresee what may happen in 20 years’ time.

We would like to find simple solutions so that farmers find it worthwhile and cost-effective to vaccinate their poultry, chickens, turkey and other birds, which now have to be killed in the event of an epidemic. During the latest epidemic, farmers received compensation for the slaughtered poultry—they got money without the need to bother about selling their poultry. As a result, some suggested that this was actually a profitable deal for them. However, we all fear that the avian flu virus will come out of chicken coops one day and will become dangerous to us. Especially, if it mutates with the swine flu virus. Swine flu is less infectious, but it is a much more severe disease. Such a mutation may result in an easily transmittable virus causing a serious disease in humans. In order to prevent this, it is necessary to vaccinate not only poultry but also wildfowl.

Do you think farmers will find it worthwhile to vaccinate their poultry flocks?

If we manage to develop a vaccine that can be administered with feed or water instead of in the form of injections, then this product will stand a chance of coming into widespread use. At present, there are several standard vaccines used in chicken breeding that do not need to be injected. Adding one more vaccine will not be a problem—everyone will benefit.

But if our vaccine will have to be administered as an injection the situation will be more difficult. Our results are very promising. The first vaccine we made worked very well. Although it was in the form of an injection, all the vaccinated chickens which were later infected with avian flu survived. What is more, they did not infect healthy unvaccinated chickens. We are now working on a kind of vaccine delivered with fodder.

If we manage to develop a good avian flu vaccine the method may be used to produce vaccines against other diseases, not only the flu. Much will depend on government policies in different countries. It is worth remembering that vaccines are for the poor, while drugs are for the rich, as the saying goes. This is true not only of patients, but also states. Progress in the drug sector means that governments are spending more and more on reimbursement programs for modern pharmaceuticals. This puts a burden on the national budget not only in Poland, but also Germany, France and other countries. Vaccines are cheap and offer great savings. The problem is that no one likes to spend money before they get sick.

How will your vaccines be put to commercial use?

We do not have to do that on our own under the program. We have to find a company that will bring our research results to the marketplace. The problem is that Polish firms are not ready technologically to produce such vaccines. The Polish vaccine industry has collapsed and needs to be revived from scratch. If there are no companies interested in producing the vaccines then perhaps the best way is to simply start such a business.

Why was it necessary to set up a consortium of three scientific institutions to carry out your project?

The vaccine project is being carried out by a scientific consortium of the Institute of Biotechnology and Antibiotics, the Polish Academy of Sciences’ Institute of Biochemistry and Biophysics, and the University of Gdańsk. The IBA has extensive expertise in insulin research. But as regards vaccines, we look to our more experienced colleagues at the Institute of Biochemistry and Biophysics. In turn, the Department of Molecular Virology at the University of Gdańsk has excellent researchers specializing in research on viruses and in designing virus-like particles. Thanks to their gene-recombination technique, our vaccines are 100-percent safe.

Does your project involve any non-research tasks as well?

Our primary task is to persuade a prospective producer to put the products that will be developed in the project, to commercial use. Under the Innovative Economy Operational Program, we have agreed to publish our research findings. But this is not enough to ensure that there will be at least one manufacturer interested in launching production once the project has been completed. This explains why we are promoting the project and are trying to anticipate its potential results. It is important to reach potential producers still at the stage of research to learn about what they need.

The vaccine project covers only an initial stage of pre-clinical tests, which may make it look less attractive for producers. But sooner or later prevention will find its due place in government drug reimbursement programs. The avian flu vaccine is not the only objective of our research. In fact, our goal is to develop a whole system of new vaccines for people and animals.
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