一次性使用系统(single use system,SUS)具有简便、灵活、成本低等优势,广泛用于抗体药物的工艺开发和商业化生产中。但是,在抗体药物的生产过程中,SUS或组件会产生可提取物和浸出物(extractables and leachables,E&L),影响产品质量...一次性使用系统(single use system,SUS)具有简便、灵活、成本低等优势,广泛用于抗体药物的工艺开发和商业化生产中。但是,在抗体药物的生产过程中,SUS或组件会产生可提取物和浸出物(extractables and leachables,E&L),影响产品质量,给患者的健康带来风险。因此,在药物上市申报前,需对SUS进行E&L研究,以证明其控制策略和安全性。近年来,随着抗体制药行业的不断发展与完善,国内外法规对E&L研究的要求也越来越高。本文总结了E&L相关的法规与行业要求,并结合抗体药物在国内外成功申报的经验,详细介绍了E&L的研究思路和考量,包括信息收集、风险评估、E&L研究和安全性评估。展开更多
In air-cooled condenser, high temperature condensing water m summer which approaching and exceed 60＊ C, which may result in filter materials degradation and release impurities. This paper discusses an influencing fac...In air-cooled condenser, high temperature condensing water m summer which approaching and exceed 60＊ C, which may result in filter materials degradation and release impurities. This paper discusses an influencing factor, water-filter ratio （soaking solution and filter quality ratio）, on leachable dissolution rate and filter material degradation rate m high temperature water. The UV absorption at 254nm （A254） and the exchange capacity ware measured after heat test as composite indicators. In addition, the Wends of A254 variation with heating time were measured in different water-filter ratio. The stability is probably due to the effect of water-filter ratio. This has been further borne out that, water-filter ratio increases, leachable concentration decreases exponentially and tends to a fLxed value.展开更多
文摘一次性使用系统(single use system,SUS)具有简便、灵活、成本低等优势,广泛用于抗体药物的工艺开发和商业化生产中。但是,在抗体药物的生产过程中,SUS或组件会产生可提取物和浸出物(extractables and leachables,E&L),影响产品质量,给患者的健康带来风险。因此,在药物上市申报前,需对SUS进行E&L研究,以证明其控制策略和安全性。近年来,随着抗体制药行业的不断发展与完善,国内外法规对E&L研究的要求也越来越高。本文总结了E&L相关的法规与行业要求,并结合抗体药物在国内外成功申报的经验,详细介绍了E&L的研究思路和考量,包括信息收集、风险评估、E&L研究和安全性评估。
文摘In air-cooled condenser, high temperature condensing water m summer which approaching and exceed 60＊ C, which may result in filter materials degradation and release impurities. This paper discusses an influencing factor, water-filter ratio （soaking solution and filter quality ratio）, on leachable dissolution rate and filter material degradation rate m high temperature water. The UV absorption at 254nm （A254） and the exchange capacity ware measured after heat test as composite indicators. In addition, the Wends of A254 variation with heating time were measured in different water-filter ratio. The stability is probably due to the effect of water-filter ratio. This has been further borne out that, water-filter ratio increases, leachable concentration decreases exponentially and tends to a fLxed value.
