旨在建立注射用重组抗肿瘤坏死因子-α人鼠嵌合单克隆抗体病毒去除/灭活工艺,并进行效果验证。膜过滤工艺去除病毒验证结果表明,膜过滤后的蛋白质回收率在98%以上,分子排阻色谱纯度在膜过滤前后没有明显变化;经测试,膜过滤后小鼠白血病...旨在建立注射用重组抗肿瘤坏死因子-α人鼠嵌合单克隆抗体病毒去除/灭活工艺,并进行效果验证。膜过滤工艺去除病毒验证结果表明,膜过滤后的蛋白质回收率在98%以上,分子排阻色谱纯度在膜过滤前后没有明显变化;经测试,膜过滤后小鼠白血病病毒、小鼠微小病毒、呼肠孤病毒滴度的降幅均大于4 lg TCID 50/0.1 mL。低pH值孵放灭活病毒验证工艺结果表明,低pH值孵放前后蛋白质含量、分子排阻色谱纯度没有明显变化;测试结果表明,室温处理时间≥0.5 h,小鼠白血病病毒、伪狂犬病毒的滴度降幅均大于4 lg TCID 50/0.1 mL。该去除/灭活效果均符合《生物组织提取制品和真核细胞表达制品的病毒安全性评价技术审评一般原则》的要求,建立的工艺有效保证了产品的质量及安全性。展开更多
Randomized, controlled studies have shown that infliximab, the chimeric anti- tumor necrosis factor alpha (TNF-α) antibody, is effective for the treatment o f active and fistulizing Crohn’s disease. Because inflixim...Randomized, controlled studies have shown that infliximab, the chimeric anti- tumor necrosis factor alpha (TNF-α) antibody, is effective for the treatment o f active and fistulizing Crohn’s disease. Because infliximab is beneficial in p atients with Crohn’s disease, in whom other therapies have failed, it has been postulated that infliximab may also be helpful in patients with ulcerative colit is. Many investigators have studied the effectiveness of infliximab in ulcerativ e colitis, mainly in patients who are refractory to corticosteroids. Unfortunate ly, these studies have not yielded a conclusive answer to the efficacy of inflix imab in inducing remission in patients with severe ulcerative colitis. However, some have reported excellent results and others less effective, with the overall data being inconclusive. The purpose of this review is to summarize the current literature on the use of infliximab in ulcerative colitis, aswell as to provide insight into the possible mechanisms of why it may or may not work in these dif ficult-to-treat patients.展开更多
文摘旨在建立注射用重组抗肿瘤坏死因子-α人鼠嵌合单克隆抗体病毒去除/灭活工艺,并进行效果验证。膜过滤工艺去除病毒验证结果表明,膜过滤后的蛋白质回收率在98%以上,分子排阻色谱纯度在膜过滤前后没有明显变化;经测试,膜过滤后小鼠白血病病毒、小鼠微小病毒、呼肠孤病毒滴度的降幅均大于4 lg TCID 50/0.1 mL。低pH值孵放灭活病毒验证工艺结果表明,低pH值孵放前后蛋白质含量、分子排阻色谱纯度没有明显变化;测试结果表明,室温处理时间≥0.5 h,小鼠白血病病毒、伪狂犬病毒的滴度降幅均大于4 lg TCID 50/0.1 mL。该去除/灭活效果均符合《生物组织提取制品和真核细胞表达制品的病毒安全性评价技术审评一般原则》的要求,建立的工艺有效保证了产品的质量及安全性。
文摘Randomized, controlled studies have shown that infliximab, the chimeric anti- tumor necrosis factor alpha (TNF-α) antibody, is effective for the treatment o f active and fistulizing Crohn’s disease. Because infliximab is beneficial in p atients with Crohn’s disease, in whom other therapies have failed, it has been postulated that infliximab may also be helpful in patients with ulcerative colit is. Many investigators have studied the effectiveness of infliximab in ulcerativ e colitis, mainly in patients who are refractory to corticosteroids. Unfortunate ly, these studies have not yielded a conclusive answer to the efficacy of inflix imab in inducing remission in patients with severe ulcerative colitis. However, some have reported excellent results and others less effective, with the overall data being inconclusive. The purpose of this review is to summarize the current literature on the use of infliximab in ulcerative colitis, aswell as to provide insight into the possible mechanisms of why it may or may not work in these dif ficult-to-treat patients.
