为了提供改善健康和改善生活的使命，患者需要获得安全有效的治疗方法。作为安全测试的一部分，当药品制造商创建其批次的持牌药物或生物技术衍生产品时，通常会进行异常毒性测试，也称为一般安全测试。
尽管制造遵循严格的质量控制过程，但异常的毒性测试也可以检测出意外问题，例如污染杂质，产品的分解或生产过程的变化，所有这些都会导致批准的药物的毒性增加。
药品manufacturers often rely on CROs like Covance for their abnormal toxicity testing. Al Catalano, Operations Manager II of BioCMC at Covance, shared a few insights for finding a partner to support this test for quality and safety.
支持全球药品的测试
“For products that are already marketed, many European pharmaceutical companies are looking for a partner in the U.S. that can support their general safety testing,” explained Al. “The Medicines and Healthcare products Regulatory Agency (MHRA) audited our GMP lab at our Greenfield site so we are approved to support drug manufacturers in the EU and U.S.”
该伙伴关系通过MHRA与FDA之间的相互认可协议作品。在美国的测试中允许在欧洲的产品释放，其中这种类型in vivo测试已在很大程度上停止。
“Manufacturers are looking for a testing partner that has a solid quality management system as well as a high level of experience and training,” said Al. “Our team at Covance follows current or cGMP regulations and can help manufacturers understand any of the requirements of USP compendial monographs. We can also help them through feasibility, validation, and batch release protocol development and testing to develop specific and or generic methods for this analysis of their product(s) together based on our 30 years of running these assays and customize their safety testing, as needed.”
超出异常毒性的USP参考测试
The Covance Greenfield BioCMC team also offers several other methods, such as
- USP <121>胰岛素生物直觉/生物能力
- USP <123> Glucagon biopotency
- USP <88> Biological reactivity tests, in vivo
“The industry and Covance have been transitioning some of these methods to cell-based assays,” added Al. “But it is important to note that some countries won’t accept in vitro alternatives and will only accept in vivo test results. However, by offering both types of testing, we can give sponsors more choices in their safety testing. And, as part of Covance, we can a wide range of services, from cell-based assays for protein chemistry, mass spec and other related solutions to support GMP batch release.”
