Critical Risk Analysis Research Articles

Enhanced biotechnological process for antivenom production using Quality by Design methodology

Snakebites envenoming are a global public health problem that largely affects economically vulnerable populations. The primary recognized treatment involves hyperimmune serum, consisting of sterile and heterologous immunoglobulin solutions targeting specific antigens. One established production method in Vital Brazil Institute involves antibody digestion by pepsin, fractionation with ammonium sulfate salt, and thermocoagulation, yielding 30-40% and requiring a 5-day duration. This study aims to assess a novel production method centered on recovering the (Fab’)2 fraction using caprylic acid, intending to implement a more efficient technological process. A new methodology was developed, defining digestion conditions (37 °C, pH 3.2; 2.5 g L-1 of pepsin over 120 minutes at 150 rpm) and fractionation parameters (37 °C, pH 5.8; 2% caprylic acid over 60 minutes at 250 rpm). These conditions were established through the application of Quality by Design, supported by a critical risk analysis. This method reduced the usage of raw materials, process time, and labor cost per hour while maintaining yield with greater purity. These modifications were promising, resulting in higher purity and lower manufacturing costs, thereby expanding the prospect of achieving a more robust production process with a safer, optimized product. This allows meeting production goals and exploring new opportunities in foreign markets.

Heterogeneous and unconventional coalitions around global food risks: integrating Brazil into the debates

Current debates about food-borne risks (GMOs and BSE) have not only deepened public concern about how food is produced on farms, processed in factories, and transported, stored and traded. More importantly, these debates have exposed a crisis related to central social issues, such as the role of science, politics and business corporations in the decision-making processes for determining which risks societies should, or are prepared to, assume. In this article, I discuss how cultural and social constructivist studies of environmental and health risks and Ulrich Beck's theory of world risk society can contribute to the analysis of how to deal with these conflicts. The criticism of quantitative methods of risk analysis has resulted in a certain idealization of the lay knowledge of risks as being intuitively more correct than the scientific one. One consequence of this polarization between expert and lay knowledge—idealizing the latter—is a disappointing vagueness when looking for alternatives on how to deal practically with risks that have important consequences. A key obstacle to the implementation of some of the suggestions presented by the critical risk analysis approach is that, for example, in the current global dynamics of food-borne risks we can find heterogeneous alliances for and against GMOs allying lay people and experts, as well as conventional and unconventional social actors, in a complicated manner, at the regional, national and international levels. Since a significant part of the analysis of manufactured risks focuses on the situation of highly industrialized countries, a more complex perspective of these lay and scientific alliances can be obtained from a more extensive study of the reactions surrounding GMOs and BSE in less-industrialized countries, such as Brazil. Copyright © 2002 John Wiley & Sons, Ltd.