[LAL (Limulus Amoebocyte Lysate) test as applied to the safety evaluation of biological preparations].

In the paper some problems concerning of pyrogen testing were described. The risk of reactions after administration parenteral preparations contaminated pyrogenic substances give the cause for searching sensitive, repeated methods of their designation. The paper is review of the adaptation Limulus Amoebocyte Lysate (LAL) test for the estimation of endotoxin in biological preparations.

[LAL test used for detection of undesirable biologically active substances in biopreparations].

Detection of bacterial endotoxin was performed in four groups of biopreparations: IVIG, virus and bacterial vaccines and antibiotics. The 44 samples of biopreparations were tested by the qualitative LAL-test (gel-clot) and some of them (22 samples) by the quantitative, LAL-test (chromogenic end-point). The concentration of endotoxin in 10 samples of IVIG was in the range from 0.

[Usefulness of the cytotoxic test for testing levels of diphtheria antibodies in sera of immunized animals].

Vero cells method was used for determination of antibodies level in humans vaccinated with Td vaccine and also in animals immunized with Di, DiTe, Td and DTP vaccines. We have found quite high levels of antibodies in both groups of animals. There was also a significant increase of antibody level in the human sera after Td booster dose in the CCV and HA tests, but the correlation with antitoxin titre was low.

[Improvement in the laboratory methods of assessing the safety of the of the pertussis component of DPT vaccine adsorbed].

The mouse paw edema test and the tests for the determination of leukocytosis-stimulating and histamine-sensitizing activity are reproducible if standard samples are used and the properties under test are evaluated with reference to the characteristics of standard samples. The standard character of the weight gain test on mice is also enhanced if all conditions of the test are standardized. The most accurate information on the toxicity of the pertussis component of adsorbed DPT vaccine can be obtained if a single human dose (0.