Chemical contaminants in human serum albumin: presence of glucose and ethanol in freeze-dried or ultrafiltered products.

Glucose and Ethanol are determined in final Human Serum Albumin solutions, obtained by two different processes: freeze-drying (FD) and ultrafiltration (UF). The elimination rate for glucose is higher than that for ethanol in case of ultrafiltration. The concentration of both "contaminants" seems to be much lower by UF than by FD. From these data arises the question of a limit-value for fractionating agents, in the final product. In the case of FD process, as the reagents remain in the product final, they all must be strongly controlled. As a large part of small molecules can be eliminated by UF process, it permits to seek new reagents for protein separation.

HBs antigen in human plasma fractions.

Therapeutic fractions were obtained by fractionating human plasma containing HBs antigen, by the Cohn ethanol technique modified by Nitschmann. Plasmas with various HBs antigen titers were selected. The antigen was sought in each fraction by the techniques of counterelectrophoresis and radioimmunological detection in liquid phase. With the exception of very pure albumins, all fractions were found to contain the HBs antigen, though in variable proportions. A technique for the purification of albumin, applicable on an industrial scale, is proposed. It makes it possible to obtain an albumin fraction in which the HBs antigen cannot be detected by the most sensitive techniques, even starting with a plasma which is very rich in HBs antigen (titer 1/64 by counterelectrophoresis).

[Biological studies and research of immunologic deficiencies in blood donors from a prison environment]. / Explorations biologiques et recherches de déficits immunitaires chez les donneurs de sang en milieu carcéral.

The prison population may be considered as a population at risk for AIDS. Biological parameters were studied in order to detect significant anomalies commonly observed in AIDS patients. With respect to are age matched control population of donors, there are no statistically significant differences concerning the nutritional and inflammatory states of the two populations. The investigation of the humoral immunity shows comparable levels of circulating antibodies in the two groups: a high level of anti-cytomegalovirus and anti-herpes antibodies is more frequently found in the penal population. The markers for hepatitis B were also studied. None of the individuals is a carrier of the HBs antigen. The percentage of individuals having biological markers of hepatitis B is higher in the at risk group (45%) than in the control group (10%). The evaluation of the cell-mediated immunity shows that there are no significant differences between the mean values found in the two groups for OKT3, T11, OKT4 and OKT8. There is no inversed OKT4/OKT8 ratio in the at risk group while one donor in the control group shows an inversed OKT4/OKT8 ratio.

Report of a working group for the European Pharmacopoeia. Collaborative assay on human albumin of different origin.

A collaborative assay was conducted by 9 laboratories on 31 samples of human albumin which were in clinical use. It was the object of the study to establish test systems which would differentiate between albumins of venous or placental origin. The properties examined for this purpose were: appearance, total protein, haem, polymers, alkaline phosphatase and blood group substances. Additional tests such as for beta-thromboglobulin and citrate were included; pyrogenicity, however, was excluded because this was under study for all plasma proteins at that time. Results obtained were in satisfactory agreement both between laboratories and between samples. They, therefore, enabled the verification of a number of correlations in the test systems. The evaluation did not allow, however, the differentiation of the samples in relation to their origin. The results were, therefore, regarded as a tool to define the upper limits of acceptance for human albumins corresponding to the quality prescribed by the European Pharmacopoeia.

[Various characteristics of intravenous polyvalent immunoglobulins]. / A propos de certaines caractéristiques des immunoglobulines polyvalentes intraveineuses (GVP).

Polyvalent human immunoglobulins for intravenous use (GVP) are obtained by fractionating human plasma with ethanol, according to a method in which traces of pepsin at pH4 eliminate any anticomplementary activity. All the analytical tests have come within official requirements. Results of extended tests concerning specificity, potency, immunoglobulin subclass distribution, biological half-life and opsonic function are presented. Since their official release for clinical use on July 1st, 1983, almost 15,000 therapeutic units of 2.5 g of immunoglobulins have been consumed without any reported major side effects. Multicenter clinical trials are being carried out with adults and children. Available results confirm very good tolerance, and, as expected, effectiveness for well known and codified indications.