15 July 2009

From Siberia with a vaccine

Koltsovskaya company is ready to solve the problem of shortage of donor blood products
Victor Smorodinov, Сибкрай.ги

The obvious favorites of the recently held Third Siberian Venture Fair were the companies of the Koltsovo science city. They took away four awards out of five. Among them, the Silver Diploma of the fair in the nomination "Promising Business" was awarded to the company "Vector-BiAlgam", a leading Russian manufacturer of medical immunobiological drugs.

The company's product range is quite diverse, but it is particularly worth emphasizing that today Vector-BiAlgam is the only manufacturer of hepatitis A vaccine in Russia – Gep-A-in-Vak. This vaccine was developed by specialists of the State Scientific Center of Virology and Biotechnology "Vector" and the Moscow Institute of Polio and Viral Encephalitis named after M.P. Chumakov. The industrial technology of its production belongs to Vector-BiAlgam CJSC.

To date, four hepatitis A vaccines are allowed in Russia. In addition to the Russian one, these are AVAXIM vaccines (manufacturer Aventis Pasteur, France), VAQTA (Merck & Co., Inc., USA) and HAVRIX (Smith Klein Beacham, Belgium). With a comparable effect of immunization, the Koltsovskaya "Gep-A-in-Vak" differs favorably from foreign analogues in that it does not contain preservatives and antibiotics. In other words, it does not cause allergies and can be used more widely. Suffice it to say that for all the years of the release of the "Gep-A-in-Vak" vaccine, the company has not received a single complaint. Plus, the cost of the domestic vaccine is almost twice as low – 500-600 rubles for an adult dose against 1000-1200 rubles for imported drugs.

Vector-BiAlgam is not only a production company. Together with the SSC of the World Bank "Vector", the State Institute of Standardization and Control of Medicines named after L.A. Tarasevich, the Institute of Clinical Immunology of the SB RAMS, its employees also participate in research work. As a result of this cooperation, the combined vaccine "Gep-A+V-in-Vac" was obtained, among other things, and this development is also unique for Russia. Until now, vaccination against hepatitis A and B has been carried out by twice administering the hepatitis A vaccine and three times against hepatitis B. A combined vaccine can not only create protection against both infections, but also halve the number of injections.

At the third Siberian Venture Fair, Vector-BiAlgam presented three projects to create new production facilities. The first of them is just "Production and bottling of vaccines against hepatitis A and B viruses at the site of Vector-BiAlgam CJSC. According to the developers, it will take three years and 136.4 million rubles of investment to implement it.

From the point of view of a venture investor, this project carries minimal risks. And first of all, because the first stage of production has already been launched, and by the company itself and in a short time – in just a year and a half. To date, the volume of vaccine production is already about 700 thousand doses per year. The planned capacity is 1.5 million doses of hepatitis A vaccine, plus half a million doses of combined A+B vaccine.

Another project prepared by Vector-BiAlgam CJSC for the Siberian Venture Fair also looks quite obvious. This is the creation of a bottling site for injectable drugs in accordance with GMP requirements. The volume of required investments is 89.2 million rubles. The implementation period is 21 months.

– The creation of this site, – says the director of the company Leonid Nikulin, – is necessary, on the one hand, for the bottling of our vaccines against hepatitis A and B. On the other hand, it is a reserve for our future developments. In addition, there are already agreements with a number of pharmaceutical companies on bottling their medicines with us after we implement this project. The fact is that the equipment that exists today has a very high performance, and we simply will not be able to completely load the site with our own products. Therefore, it is quite logical to take third-party orders. In this case, he will be able to pay off quickly enough. By the way, the practice of such cooperation exists in many quite developed European countries.

Both projects presented by Vector-BiAlgam CJSC are quite real and due to their very high preparedness. The company already has the necessary production facilities with all utilities. The most important thing is qualified personnel. In fact, the company employs the same people who were at the origins of the creation of vaccines against hepatitis A and B, while working at the Vector World Health Center. Plus, all the company's management personnel have been trained in GMP rules for the production and control of medicines.

It must be said here that GMP (Good Manufacturing Practice – Good Practice in the production of medicines) imposes rather stringent requirements. This is an aseptic production with constant monitoring of all processes, the use of modern waste disposal systems, environmental control, well-documented standard operations that guarantee absolute sterility of the product. Only if all these requirements are met, you can license your products abroad. Since the work is carried out with active viruses, the safety of production is also increased – code locks for entering zoned premises, gateways, door locking system, video surveillance.

The third project looks more complicated among the projects of the company's new production facilities – "Creation of an enterprise for deep processing of donor blood". We are talking here, first of all, about the production of specific immunoglobulins for the treatment of various infectious diseases, the treatment of patients with poor blood clotting, etc. In reality, more than two dozen different drugs can already be obtained from donated blood, but there are no such productions in Russia. And this is not only a Russian problem, the shortage of specific immunoglobulins is felt all over the world.

– It is really difficult to find an investor for the implementation of this project, – Leonid Nikulin agrees, – first of all because we do not have a ready-made production yet, there is nothing to see. We have been dealing with donor blood preparations for a long time, but in laboratory conditions, it has not yet been possible to scale these processes to industrial production. Although design studies with all technical, technological solutions exist. There is also a business plan. Investors are also stopped by the fact that drugs from donated blood require special treatment. Everyone knows how much effort and time can be spent on testing, verification, approval. This is true, but for us, with our experience, all this no longer presents such problems. We've been through this before. As in other projects, our strengths here are the availability of production facilities and qualified personnel, work experience within the requirements of international GMP regulations.

The market of therapeutic and prophylactic drugs strongly depends on the general epidemiological situation. And if you look at the same hepatitis, then you can not call it safe in any way. According to the World Health Organization, the number of cases of hepatitis A alone in the world reaches 1.5 million cases annually. According to Russian epidemiologists, there are several million patients with chronic viral hepatitis in Russia. In terms of the scale of spread and damage to the health of the nation, these diseases significantly exceed HIV infections. Moreover, the existing sales volumes of vaccines against hepatitis A and B are far behind the real need for these drugs.

By the way, if you approach the problem economically – which is more expensive, vaccination against hepatitis or treatment – then treatment is certainly more expensive. At the Fourth European Congress of Pediatricians held in Moscow in July, for example, the following figures were called: the total damage from all viral hepatitis in Russia is at least one billion rubles a year, and in the world it exceeds three billion dollars.

It is not for nothing that more and more specialists are inclined to think that mass vaccination against hepatitis is the only strategy with which it is possible to control the spread of infections in principle. And for this (both from the point of view of the national economy and from the point of view of national security) of course, we must have our own biological products and our own production.

Portal "Eternal youth" http://vechnayamolodost.ru15.07.2009

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