[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.

[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.

[Trophoblastic beta-globulin in immunoglobulin preparations]. / Trofoblasticheskii beta-globulin v preparatakh immunoglobulinov.

The content of trophoblastic beta-globulin in 142 lots of commercial immunoglobulin preparations from 20 manufacturers, produced from placental, abortion and donor blood sera, has been studied. 83% of lots from abortion blood serum and 94% of lots from placental blood serum have been found to contain the admixture of this beta-globulin, its concentration in the lots from placental blood serum being significantly higher. The method for the detection of trophoblastic beta-globulin may be used for evaluating the quality of immunoglobulin preparations as it indicates the degree of their purification from placental proteins.

[Ratio of admixtures of blood group substances and heme pigments in immunoglobulin preparations from different types of raw material]. / Sootnoshenie primesei gruppovykh veshchestv krovi i gempigmentov v preparatakh immunoglobulinov iz razlichnykh vidov syr'ia.

The study of 192 batches of immunoglobulin preparations for the presence of the admixtures of blood group substances and blood pigments has revealed that preparations obtained from abortion and placental blood sera significantly differ from donor immunoglobulins by a greater content of the above admixtures. The absence of correlation between the content of blood pigments and blood group substances in preparations from abortion and placental blood has been significantly demonstrated.

[Radioimmunologic determination of several hormones in commercial immunoglobulin preparations]. / Radioimmunologicheskoe opredelenie nekotorykh gormonov v kommercheskikh preparatakh immunoglobulinov.

Radioimmunological method with the aid of standard sets was applied to determination of the content of chorionic gonadotropin, placental lactorgen, prolactin, folliculo-stimulating and luteinizing hormones in the immunoglobulin preparations made of abortion and placental blood serum. Serum fractionation by Cohn's method (technological variant B) led to reduction in the immunoglobulin preparations of polypeptide hormones (placental lactogen and prolactin) content, but it was not sufficiently effective in respect to glucoprotein hormones.

[The content of gonadotropic hormones in commercial immunoglobulin preparations]. / Issledovanie soderzhaniia gonadotropnykh gormonov v kommercheskikh preparatakh immunoglobulinov.

The authors carried out a comparative quantitative and biological determination of gonadotropins in 32 batches of immunoglobulin preparations made of the abortive, placental, and donor blood sera. The maximal amounts of gonadotropins were contained in preparations obtained from the abortive blood serum. It was shown that purification by Kohn's method (variant B) led only to the partial purification of immunoglobulins from the gonadotropin admixtures.