Tiêu đề 22. STANDARDISATION OF VACCINES AND SERA.pdf ✅

PHARMD GURU Page 2  The BCG albumin assay is designed to measure albumin directly without any pretreatment of samples, such as serum, plasma, urine, and biological preparations.  It may also be used to measure effects of drugs and other compounds on albumin metabolism. It can be used for corvette or multiwall plate assays.  The multiwall plate assay uses samples as small as 5 mL and can be readily automated as a high-throughput assay for thousands of samples per day.  The procedure involves addition of a single working reagent and 5 minute incubation. The intensity of the color, measured at 620 nm, is directly proportional to the albumin concentration in the sample. SAFETY TEST:  The abnormal toxicity test (ATT) using mice and guinea pigs is a non-specific safety test for vaccines, sera and immunoglobulins.  Positive ATT's never resulted from the insufficient quality of a batch.  On the other hand, vaccines causing adverse reactions In the target species were not identified by the ATT. ENDOTOXINS TEST:  Twenty samples of commercial vaccines intended for administration to humans were assayed for the presence of bacterial endotoxins by using the Limulus amebocyte lysate test.  Sixteen of the vaccines contained more than 0.1 mg of endotoxins per ml.  These results suggest that at some stage of preparation, the vaccines have contained varying amounts of gram-negative bacteria and may indicate the presence of other bacterial products as well.