In vitro potency results from a collaborative study of RhO(D) immune globulin reference preparation.
Explore the source record for details and available documents.
Biomedical subjects
Publications and source records attributed to E B Seligmann.
Explore the source record for details and available documents.
An improved cutter is described for cutting membrane filters in half during the performance of sterility tests on drugs.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
Previous papers in this series have shown that plain toxoids induced early primary antitoxin levels in women in New Guinea that were not significantly different from those induced by adsorbed toxoids but that at the end of 1 year the antitoxin levels differed significantly. Protective levels (not less than 0.01 unit/ml) induced by adsorbed toxoids persisted for more than 3 years. Results of laboratory assays of the toxoids reported in this paper show that per total human immunizing dose, the plain toxoids had 72 or less international units (IU) whereas the adsorbed toxoids had approximately 200 IU. The international "unitage" of these toxoids reflected the persistence of the human protective antitoxin level but not the early primary response. The assay results were in agreement with findings of other workers that the mouse as well as the guinea-pig may be satisfactory for potency assay of adsorbed toxoids. The need for determination of the international unitage of tetanus toxoids used in human studies and the confirmation of relationship of this value to persistence of antitoxin levels is emphasized.
Avian leukosis virus (ALV)-free candidate primary and secondary seed lots were indistinguishable from corresponding ALV-contaminated lots with respect to (i) potency as measured by titration in newborn and weanling mice and in the MA-104 plaque system, (ii) degree of viscerotropism as measured by viremia in monkeys, (iii) neurotropism as determined by the monkey neurovirulence test, and (iv) potency as determined by antibody response in monkeys inoculated by the intracerebral route.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
In November, 1974, eight patients in three hospitals had pyrogen reactions associated with the infusion of 25% Normal Serum Albumin from the same lot. The reactions were recognized because the same physician or nurse observed several patients having recurrent reactions or because a single patient receiving several vials had consecutive reactions. The remaining albumin in three vials associated with reactions had apparent endotoxin concentrations of 4, 16, and 32 ng/ml and that 22 vials from recalled supplies had a median concentration of 4 ng/ml (range: 2 to 64) as determined by the Limulus amebocyte lysate test, but the lot again passed the rabbit pyrogen test. In a prospective study to determine the efficacy of the Limulus test in quality control, patients had their temperatures taken hourly during albumin infusions and the remaining fluid was tested by the Limulus assay. The albumin in 443 of the 662 vials infused (65%) gave a positive test and 311 of these vials (45%) had apparent endotoxin concentrations of 4 to 64 ng/ml, but no patient had a reaction. Because of the limitations of both the rabbit pyrogen and Limulus test, the detection of some pyrogenic lots continues to depend on hospital surveillance and reporting os suspect reactions.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
Explore the source record for details and available documents.