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首页> 外文期刊>Journal of toxicology and environmental health, Part B. Critical reviews >Good management practices of venomous snakes in captivity to produce biological venom-based medicines: achieving replicability and contributing to pharmaceutical industry
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Good management practices of venomous snakes in captivity to produce biological venom-based medicines: achieving replicability and contributing to pharmaceutical industry

机译：颈部腐殖蛇的良好管理实践，以生产基于生物毒液的药物：实现可重复性并为制药行业提供贡献

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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 Sao Paulo State University (UNESP), Sao 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.
机译：缺乏可重复性结果的原因之一可能是所用的原材料。到目前为止，还没有针对监管机构的政策，对使用毒液开发新型毒素药物的再现性进行明显研究。出于这个原因，实施了协议，以生产质量高、可追溯性强、严格遵守良好生产规范的动物毒素。这需要对从动物到达活体的生产链进行验证，然后进行处理、安置，以及遵守提取、冷冻干燥和最终储存协议，目的是生成化合物，作为适用于临床试验的候选分子。目前，为了生产高质量的蛇毒以支持生殖研究，巴西圣保罗州立大学（UNESP）的毒液和有毒动物研究中心（CEVAP）通过严格和标准化的操作程序为动物的安全、健康和福利生产了449条微芯片蛇。蛇经常接受兽医临床检查、驱虫和抗寄生虫治疗。为了避免污染和可追溯性，用塑料微管从每只动物身上收集毒液来消灭猎物。此外，毒液还进行了微生物和生化毒理学分析。值得注意的是，调查人员负责照料、维护和操纵蛇，并确保它们在圈养期间的健康。本综述旨在为制药业提供实验经验和整个蛇毒生产链，以生产高质量的治疗性人类消费产品。

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