Blood preparations of humans and animals in terms of their quality, efficacy and safety

The problems of quality and safety products derived from human blood plasma and hyperimmune animal sera as well as recombinant blood products resolved strict government regulation of their production processes. The risk of implications is minimized by plasma fractionation and purification of a specific drugs from various impurities (immunoglobulin aggregates, protease, plasmin, plasminogen, prekallikrein activator, IgA and IgM etc.). Viral safety is achieved by multi-step manufacturing process that includes at least two independent methods (treatment with solvent/detergent + incubation at low pH or pasteurization, combined with polyethylene glycol processing). It was justified that for today the technological process of the development of plasma preparations and hyperimmune animal sera has reached its limit. Their further development is the most likely to refer to specific improvements. The improvements will relate to increasing the efficiency of manufacturing technologies and methods of clinical use (preparations for subcutaneous administration, combinations of different immunoglobulin preparations, etc.), viral safety, ways to eliminate component, that were previously not considered to be able to influence the outcome of clinical use (soluble molecules CD4, CD8, HLA, thrombin, trace amounts of blood clotting factors VIII, IX, X, XI, XII etc.). At the same time new genetic engineered preparations with well-characterized molecular composition and a high selectivity for target impact are expected to appear on the market because of these unsolved issues. These are recombinant blood factors with altered properties; cocktails of recombinant antibodies and Fab-fragments of IgG, highly affine for toxin epitopes, etc. Therefore, in the upcoming years it is necessary to create in Russia a new system for assessing the quality, efficacy and safety of blood products, taking into account the future course of their development

Bio-anthropological Studies on Human Skeletons from the 6th Century Tomb of Ancient Silla Kingdom in South Korea

In November and December 2013, unidentified human skeletal remains buried in a mokgwakmyo (a traditional wooden coffin) were unearthed while conducting an archaeological investigation near Gyeongju, which was the capital of the Silla Kingdom (57 BCE– 660 CE) of ancient Korea. The human skeletal remains were preserved in relatively intact condition. In an attempt to obtain biological information on the skeleton, physical anthropological, mitochondrial DNA, stable isotope and craniofacial analyses were carried out. The results indicated that the individual was a female from the Silla period, of 155 ± 5 cm height, who died in her late thirties. The maternal lineage belonged to the haplogroup F1b1a, typical for East Asia, and the diet had been more C3- (wheat, rice and potatoes) than C4-based (maize, millet and other tropical grains). Finally, the face of the individual was reconstructed utilizing the skull (restored from osseous fragments) and three-dimensional computerized modelling system. This study, applying multi-dimensional approaches within an overall bio-anthropological analysis, was the first attempt to collect holistic biological information on human skeletal remains dating to the Silla Kingdom period of ancient Korea

Immunogenic Activity of Secreted Protein-Based Compounds Staphylococcus aureus № 6

Difficulties in the therapy of infection, caused by S. aureus, depends on the resistance of staphylococci to antibiotics, proceeding to chronicity of the diseases and the development on that background the depression of innate immunity functions and decreasing of the host resistance to the infection. In spite of tremendous efforts of researchers, up to date there are no commercial antistaphylococcal vaccine the efficacy of which would be proved in the completed clinical trials.Aim: obtaining secreted protein-based substances of the S. aureus № 6 and investigation their immunogenicity.Material and methods. Secreted protein-based substances (SPS) were obtain as: «initial» – from the filtrates of the culture fluid of the S. aureus № 6, grown to the end of the exponential phase according to the technology described previously [9], and I SPS and II SPS – after the ion-exchange chromatography of the «initial» SPS on the columns with Q-Sepharose and DEAE-Sepharose. The level of specific IgG antibodies in sera of immunized rabbits and mice determined in ELISA, the immunogenic activity evaluated in experiments of active and passive protection from the challenge performed on BALB/с mice and also by the determination of the bacterial content in organs and in the test of abscesses formation in kidneys. Results. Investigated SBS possessed the antigenic activity (the level of specific IgG antibodies in sera of immunized animals increased 2.2 – 7.5 times compared to the control groups), that is favor of the activation of the adaptive immunity system and significant protective activity revealed in experiments of active (index of efficacy 2.63 – 4.28) and passive protection. The immunization of mice with the «initial» and II SPS led to significant decrease of the number of colonyforming units of S. aureus and formation of abscesses in kidneys of mice. It is evidently, that investigated SPS, influence on the severity of staphylococcal infection and possesses the therapeutic effect.Conclusion. The preformed complex analysis at the current stage allowed to reveal perspectives of the further study of «initial» and II SPS in pre-clinical trials, as candidates, possessing the high protective facilities, for including them in the drug composition for immune prophylaxis and immunotherapy of diseases, caused by S. aureus