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Comparability testing immunogenicity

Generally established via in vivo comparability testing. Often need to assess pharmacologic activity (PD) and immunogenicity in addition to PK. [Pg.129]

A partially purified Bacillus thurlnglensis var. israelensls (Bti) 6-endotoxin was used to Immunize rabbits. The antisera obtained have an improved specificity towards the mosquito larvacidal activity of the toxin, as opposed to antiserum raised when the whole crystal was used as immunogen. Using a two step/indirect ELISA (enzyme linked immunosorbent assay) procedure developed in our laboratory, fourteen experimental formulations were tested, and the results were compared with bioassays. An average of 69.1 international units 20% c.v. was found to associate with each ug of toxin detected by the ELISA. Our data indicate that when toxin specific antisera are available, Immunoassays can be used to predict the biological activity of Bti samples with reasonable accuracy. [Pg.320]

During the course of investigations of the mouse IgE test, responses induced by TMA and DNCB have been measured concurrently in over 15 independent experiments. The test concentrations chosen for such comparisons (25 per cent TMA and 1 per cent DNCB) were selected as those that were found to be of equivalent immunogenicity in BALB/c strain mice with respect to the stimulation of draining lymph node cell proliferative responses. In all experiments the concentration of serum IgE recorded following exposure of mice to TMA was increased significantly compared with levels measured in sera drawn from animals treated concurrently with vehicle alone or with DNCB. In no instance did DNCB cause an increase in serum IgE levels relative... [Pg.125]

HORN, P.A., BABCOCK, L.S., KAWABATA, T.T. ROBINSON, M.K. (1996) Further development and characterization of a mouse intranasal method for comparative immunogenicity testing of enzymes. The Toxicologist, 30, 95. [Pg.147]

ANIMAL MODELS FOR PRECLINICAL COMPARATIVE IMMUNOGENICITY TESTING... [Pg.345]

Chapter 10.2 Animal Modeb for Preclinical Comparative Immunogenicity Testing... [Pg.417]

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See also in sourсe #XX -- [ Pg.173 ]



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