2007 Volume 9 Issue 1 Pages 32-41
Recently diseases caused by “prion” are well known as BSE (Bovine Spongiform Encephalopathy) and CJD (Creutzfeldt-Jakob disease). In manufacture of pharmaceuticals, there is potential risk of contamination of “prion” if bovine derived materials or human blood plasma are used as raw materials. Various provisions against this risk, enactment of specific regulations, development of assay method and measures in manufacture of pharmaceuticals for example, have been performed in regulatory authorities, academic organizations and pharmaceutical industry.
In this article, content and the present situation of these provisions in pharmaceuticals, especially in bio-pharmaceuticals are described.
Occurrence of BSE has been obviously decreased by the provisions like restriction of source of food for bovine, and occurrence of vCJD (variant CJD) in UK caused by BSE also seems to have been decreased. However, we can not have optimistic view regarding issues of vCJD yet. Because BSE still continues to occur in Japan, and infection risks from human to human have not been swept away. In addition, there are still scientifically unknown issues like variety of vCJD, difference of sensitivity and latent period of vCJD based on human genotypes. In short effective provisions are not clear yet.
In these situations, pharmaceuticals manufacturing companies recognize risk of contamination, and are taking preventative measures, usage of safe raw materials for example, as good as possible.
In order to make preventative measures more effective, clarification of disease mechanism, development of analytical method with high sensitivity enough to detect and to control infective substance, and development of reliable evaluation method regarding removal of possible contaminants of infective substance in manufacture process are essential. Aggressive and persevering cooperation effort among industry, regulatory and academic in long term is quite important in order to resolve these issues.
