[Prospects for designing immunoglobulins to prevent and treat purulent-inflammatory diseases]. / Perspectivy sozdaniia immunoglobulinov dlia profilaktiki i lecheniia gnoino-vospolitel'nykh zabolevanii.

The paper gives the results of prophylactic and therapeutic evaluations made in gram-negative opportunistic bacteria-induced pyoinflammatory diseases during retrospective and controlled studies of blood plasma preparations and immunoglobulins that contain antibodies to lipopolysaccharides. The data available in the literature and the authors' own findings confirm the obligatory presence of antibodies to tumor necrosis factor and to other interleukins, as well as the importance of IgM antibodies to various lipopolysaccharide determinants. The paper also presents the results the results of the authors' own investigations to design and evaluate the activity of intravenous immunoglobulin that contains antibodies to IgG and IgM lipopolysaccharides, which is termed panglobulin. Prospects for designing a combined preparation containing IgM and IgG antibodies with antiendotoxic activity and antibodies to tumor necrosis factor and other interleukins.

[Anti-Escherichia antibodies in the blood sera from nonimmunized donors and in preparations of human immunoglobulin]. / Protivoésherikhioznye antitela v syvorotkakh krovi neimmunizirovannykh donorov i preparatakh immunoglobulina cheloveka.

The anti-Escherichia activity of 188 serum samples obtained from nonimmunized blood donors and 157 batches of the preparation of commercial normal human immunoglobulin were evaluated in the passive hemagglutination test with diagnostica containing E. coli antigens (serovars O2, O14, O26) and Kunin antigen, as well as Re-glycolipid Salmonella minnesota strain R595, used as sensitins. The study demonstrated that from sera of nonimmunized blood donors and from normal human immunoglobulin preparations 5-8% of batches containing anti-Escherichia antibodies to E. coli lipopolysaccharide (serovar O2) in titers of 1:640 and more could be selected. The study revealed that certain anti-Escherichia antibodies of commercial normal human immunoglobulin, to IgG.

[The dependence of the antigen-binding activity of immunoglobulin preparations on their molecular composition]. / Zavisimost' antigensviazyvaiushchei aktivnosti preparatov immunoglobulina ot ikh molekuliarnogo sostava.

The antigen-binding activity of commercial preparations of immunoglobulin with different molecular composition was studied in the enzyme immunoassay with Escherichia coli lipopolysaccharide and serogroup B Neisseria meningitidis protein antigen. Immunoglobulin preparations for intramuscular injection were found to possess higher specific antigen-binding activity than immunoglobulin preparations for intravenous injection, which was determined by both the presence of the highly active polymer and dimer fractions and greater specific activity of the monomer fraction. A group of intramuscular immunoglobulin preparations with a considerable content of polymers were found to have significantly greater specific activity than a group of preparations containing small amounts of polymers.

[Comparative study of the quality of domestic albumin solution and foreign analogs]. / Sravnitel'noe izuchenie kachestva otechestvennogo rastvora al'bumina i zarubezhnykh analogov.

The quality and standards of albumin solutions (5, 10 and 20%) made in this country meet the requirements of national specification documentation. This, however, lacks some standards included into European Pharmacopoeia and mandatory for foreign manufacturers (Na and K ions, hemipigments, polymers, thermostability). The comparative tests of the albumin solutions made in Russia and abroad by conventional European standards showed that Russian solutions by some parameters are inferior to foreign samples. This urges improvement of the solution production technology as well as updating technical documents regulating the product quality.

[The fractional composition of immunoglobulin preparations studied by gel filtration on different carriers and by high-pressure liquid chromatography]. / Izuchenie fraktsionnogo sostava preparatov immunoglobulinov metodom gel'-fil'tratsii na razlichnykh nositeliakh i metodom zhidkostnoi khromatografii vysokogo davleniia.

The fractional composition of immunoglobulin preparations produced by different manufacturing enterprises of this country has been studied by gel chromatography in columns packed with different carriers (Sephadex G-200 and ultragel AcA-34) and by high-performance liquid chromatography (HPLC). This study has revealed the nonstandard character of immunoglobulin preparations produced according to the same technological procedure (modified Cohn's method). The fractionation of immunoglobulins on different carriers with the use of different methods has yielded similar results confirmed by the statistical processing of the data. The results obtained in the study of the fractional composition of immunoglobulin preparations evidence that gel filtration with the use of ultragel and HPLC have greater resolving capacity in comparison with the method of gel filtration on traditionally used Sephadex G-200.

[Use of group-specific contaminants A and B in albumin preparations produced from the donor, placental and abortion blood]. / Ispol'zovanie gruppospetsificheskikh kontaminantov A i B v preparatakh al'bumina, izgotovlennykh iz syvorotok donorskoi, platsentarnoi i abortnoi krovi.

Assay of group-specific blood substances (GSBS) A and B was conducted in 21 series of an albumin preparation produced from donors' blood serum, in 11 series of placental and in 5 series of "Postab" albumin. GSBS content was estimated by a comparative use of poly- and monoclonal antibodies prepared in this country. More than 80% of the preparations from donors' blood serum did not contain GSBS A and B. In the preparations obtained from placental and postabortion blood the mean levels of GSBS significantly fluctuated, and with the use of poly- and monoclonal antibodies in comprised 8.3-9.1 micrograms/ml GSBS A and 16.7-42.8 micrograms/ml GSBS B, respectively. Administration to recipients of albumin preparations contaminated with GSBS may produce an immunomodulating side effect.

[Comparative analysis of the HBsAg level in human blood preparations]. / Sravnitel'nyi analiz soderzhaniia HBsAg v preparatakh krovi cheloveka.

A total of 218 batches of blood preparations produced from different raw materials have been studied by means of enzyme immunoassay kits (Abbott Laboratories, USA). The assays have revealed that the preparations under study are nonstandard with respect to the content and isolation rate of HBsAg, the marker of hepatitis B virus. These data necessitate search for the ways of improving the quality of blood preparations.

[Interaction of human albumin with sorbents containing immobilized dyes]. / Issledovanie vzaimodeistviia chelovecheskogo al'bumina s sorbentami, soderzhashchimi immobilizovannye krasiteli.

Interaction of human albumin with immobilized dye-adsorbents was investigated by frontal chromatographic analysis and static adsorption. The relative strength of the interaction is diminished in the following order: cibacron blue F3GA, orange 4K, claret CT, orange 5K, red-brown 2KT, light resistant yellow 2KT, bright blue KX, scarlet 2Zh, bright red 6C, bright yellow 53, red-brown 2K, golden yellow 2KX, scarlet 4ZhT and yellow 2KT. Following this order the absorbents can be used for purification of human albumin from non-specific impurities taking into account stronger adsorption of albumin or impurities. Adsorbents with dyes immobilized on macroporous silica were found to be promising for large-scale purification of human albumin. The silica adsorbent containing red brown 2K is effective for the removal of the following impurities from placental albumin: chorionic gonadotropin, alpha-fetoprotein and placental lactogen.

[Effect of lyophilization on IgG aggregation processes in immunoglobulin preparations]. / Vliianie liofilizatsii na protsessy agregatsii IgG v preparatakh immunoglobulinov.

The conditions of the lyophilization of immunoglobulins as prescribed by the current technical regulations lead to the increased content of aggregated molecules in the preparation. The storage of the bulk preparation for two months after drying considerably decreases the content of aggregations. The authors believe it to be expedient to introduce the stage of storage after drying into the regulations for drying immunoglobulin preparations in the process of their production.