ABSTRACT

One of the factors responsible for lack of reproducible findings may be attributed to the raw material used. To date, there are no apparent studies examining reproducibility using venoms for the development of new toxin-based drugs with respect to regulatory agencies' policies. For this reason, protocols were implemented to produce animal toxins with quality, traceability, and strict compliance with Good Manufacturing Practices. This required validation of the production chain from the arrival of the animal to the vivarium, followed by handling, housing, as well as compliance with respect to extraction, freeze-drying, and, finally, storage protocols, aimed at generating compounds to serve as candidate molecules applicable in clinical trials. Currently, to produce quality snake venoms to support reproductive studies, the Center for the Study of Venoms and Venomous Animals (CEVAP) from São Paulo State University (UNESP), São Paulo, Brazil has 449 microchipped snakes through rigid and standardized operating procedures for safety, health, and welfare of animals. Snakes were frequently subjected to vet clinical examination, anthelmintic, and antiparasitic treatment. Venom milk used to destroy prey was collected from each animal in individual plastic microtubes to avoid contamination and for traceability. In addition, venoms were submitted to microbiological, and biochemical toxicological analyses. It is noteworthy that investigators are responsible for caring, maintaining, and manipulating snakes and ensuring their health in captivity. This review aimed to contribute to the pharmaceutical industry the experimental experience and entire snake venom production chain required to generate quality products for therapeutic human consumption.

摘要

导致缺乏可重现结果的因素之一可能是所使用的原材料。迄今为止，还没有明显的研究根据监管机构的政策检查使用毒液开发新的基于毒素的药物的可重复性。出于这个原因，实施了协议以生产具有质量、可追溯性并严格遵守良好生产规范的动物毒素。这需要对从动物到达饲养场的生产链进行验证，然后是处理、饲养以及提取、冷冻干燥和最终存储协议的合规性，旨在生成化合物以用作适用于临床试验的候选分子。目前，为了生产高质量的蛇毒来支持生殖研究，巴西圣保罗圣保罗州立大学 (UNESP) 的毒液和有毒动物研究中心 (CEVAP) 拥有 449 条微芯片蛇，它们通过严格和标准化的操作程序保护动物的安全、健康和福利。蛇经常接受兽医临床检查、驱虫和抗寄生虫治疗。用于摧毁猎物的毒液牛奶从每只动物身上收集在单独的塑料微管中，以避免污染和可追溯性。此外，还对毒液进行了微生物学和生化毒理学分析。值得注意的是，调查人员负责照顾、维护和操纵蛇，并确保它们在圈养期间的健康。