SCIENTIFIC RELEVANCE. The use of appropriately certified reference standards (RSs) is a necessary element analytical procedure standardisation that ensures comparability results across different laboratories assessing the quality medicines, which important for control biologicals. Marketing authorisation involves providing information on RSs, but no specific requirements are given relevant section dossier. Therefore, it to develop appropriate guidelines. AIM. This study aimed materials...

The main quality indicator for inactivated influenza vaccines is their potency (the amount of hemagglutinin). test the vaccine with SOVIDON adjuvant carried out in a trivalent bulk before addition adjuvant. This approach has its fair share drawbacks. analysis statistical process control and stability by charts plays an important role release vaccines. aim study to compare results hemagglutinin quanitation final lots adjuvant; as well evaluate control. covered Both bulks were investigated...

Researches and presents comparative characteristics of protective properties vaccines EC domestic foreign production by immunization line BALB/c mice in a standard experiment for estimating the immunogenic activity against virulent strains TBE virus three genotypes: genotype 1 - strain «Sof'in», 2 «Absettarov», 3 «Lesopark». The results are considerable interest evaluation efficiency interchangeability prevention areas natural foci disease Russia. Currently, circulation pathogen Russian...

Introduction. The need to maintain a high level of vaccination coverage against measles, rubella and mumps in conditions an increased risk outbreaks infections due violations tactics associated with the pandemic coronavirus infection unfavorable epidemic situation neighboring countries determines advisability using combined vaccine for simultaneous prevention these three socially significant infections.
 aim study: analyze quality commercial series new domestic cultured live (MRM)...

The article presents the results of research quality drugs for prevention smallpox during period from 2007 to 2015 years, where reference standard uses industry activity, specificity (identification) and necrotic activity vaccine, on indicators: «Specific activity», «The antigenic activity» safety». Described methods, presented statistical analysis results. also provided regular re-certification sample vaccine OOO 42-28-113-12 (ОСО), held in 2015. Branch preparation determination was...

Until recently Rubella has been a wide spread infection. Thanks to vaccination against rubella, taking part in the global elimination program of “manageable infections” WHO and adoption “Elimination measles rubella Russian Federation” morbidity index reached sporadic level. One determining conditions is application high-quality vaccines that satisfy international standards. In Federation, foreign certified our country were used for several years. 2008, commercial production domestic vaccine...

Introduction. Due to the increased incidence of measles in Russia and many other regions world, vaccines for prevention are especially demand. Ensuring quality vaccine effective disease is within scope tasks state policy our country.
 Objective. Evaluation experience using a pharmacopoeial standard material activity measurement specific virus with component that used Russian Federation prevention.
 Materials methods. The object study was Pharmacopoeia reference (PRM) live series...

Relevance. The need to increase vaccination coverage in order eliminate measles Russia and public confidence requires constant monitoring of the quality vaccines used for prevention . Aim. Analysis laboratory parameters commercial series produced by JSC NPO Microgen, issued from 2015 2020, comparison with period 2002 2009. Materials methods. object study was a live culture vaccine mumps-measles «NPO «Microgen». analysis carried out according consolidated production control protocols 422 855...

The efficacy of influenza vaccines has been a matter considerable debate ever since the development first vaccine. currently used depends on many factors, including strain composition, degree homology between produced and epidemic viruses, vaccination coverage, other factors. Assessment quality, i.e. determination compliance product’s quality characteristics with specification requirements, assessment risks associated use product were considered only in context general requirements for...

Poliomyelitis is a typical anthroponosis, in natural conditions it infects only humans. The effective strategy for combating the infection preventive vaccination. polio vaccine induces long-lasting humoral and local immunity. article presents brief history of development, compares live inactivated vaccines currently licensed used Russia. It also dwells upon benefits shortcomings each these vaccines. results analysis demonstrated that all foreign-made domestically-produced Russia meet...

Currently, the identity of measles, mumps and rubella virus vaccines is determined during certification testing by a labour-consuming, lengthy costly neutralisation test using cell cultures. The contained in such established based on cytopathic effect viruses sensitive RK-13 Vero cultures specific immune serum. An urgent challenge to simplify reduce cost controlling commercial batches polymerase chain reaction (PCR) tests. aim study was determine possibility viral ribonucleic acid (RNA)...

Introduction. Rabies is an infectious disease that always fatal following the onset of clinical symptoms. The only way to prevent cases rabies in humans timely carried out post-exposure prophylaxis accordance with recommended schedule.The aim study was characterize level immune response persons received a against rabies, consider role factors formation responses vaccines .Material and methods. In laboratory viral Scientific Centre for Expert Evaluation Medicinal Products, 48 sera patients...

The immunologic activity (specific activity) is one of the main indicators quality vaccines for prophylaxis hepatitis B, along with their safety. Retrospective analysis use laboratory methods assessment specific (immunogenic) modern against B using was carried out: in vitro method based on evaluation HBsAg content and vivo immunogenic mice. Both are standardized described normative documents domestic production registered Russian Federation. Indicators were used to investigate more than 170...

Relevance . The presence of pyrogenic impurities in finished dosage forms concentrated cultural anti-rabies vaccines produced the Russian Federation is determined using pyrogenicity tests on rabbits (in vivo). In accordance with decision Board Eurasian Economic Commission dated September 7, 2018 N 151 «On approval guidelines for drawing up a regulatory document quality medicinal product», one requirements parenteral drugs determination bacterial endotoxins. This indicates that documentation...