NPO Microgen (part of the Natsibio of Rostec State Corporation) has created the first line of reference samples in Russia for therapeutic and diagnostic pollen allergen drugs. The development will allow for the transition to modern standardization and quality control of allergen medicines in Russia and will increase their competitiveness as compared with foreign analogues. This was reported in the press service of the company.
At the first stage, the company developed and registered 15 reference samples of pollen allergens. It is planned that by the end of this year Microgen will register 11 more reference samples of such drugs, and then it will begin to create reference samples for food and household allergen drugs.
“Until recently, Russia had a problem of allergens standardization. Due to the absence of reference samples, the specific activity of drugs was measured by skin prick tests, an outdated method with lower accuracy of protein identification, which led to greater variability in the composition of drugs. The lack of an appropriate pharmacopoeial product meant that manufacturers used their own historically established methods for quality control of allergens, and, as a result, drugs in circulation varied in their components content and specific activity. We have developed the first reference samples in Russia and introduced the standardization of allergens in our production based on a new method of enzyme immunoassay using the in-house reference standard that we developed. The new approach to standardization has significantly increased the uniformity of key indicators, and this brought the quality control of allergen drugs to a new level. As a result, the manufactured products have higher indicators of specificity, efficiency, and safety. Our new method has been implemented in Russia for the first time and can form the basis of a unified national allergen standardization system,” said Elena Sakanyan, Microgen’s Science Director.
“The problem of standardization of allergen drugs is relevant worldwide. The World Health Organization currently offers no more than three or four samples for standardization in terms of specific activity, while the number of allergen drugs is significantly higher. The approach developed by Microgen’s specialists will help standardize a wide range of allergen drugs, which will increase the competitiveness of domestic products at the international level,” said Andrey Zagorsky, Director General of Natsimbio.
NPO Microgen is the only full-cycle manufacturer of allergen and allergoid drugs in Russia. Its portfolio includes 65 drugs for the diagnosis and therapy of allergies. These drugs are used both for diagnosis and for allergen-specific immunotherapy (ASIT), which is the only proven way to get rid of allergies for a long time.
As it became known earlier, a new drug for the treatment of immunodeficiency is launched on the market by NPO Microgen.