基因治疗制剂生产
对于目前的无数疾病以及患者治疗无望或者治疗手段有限的情况,基因疗法具有前所未有的治疗和治愈潜力。目前,全球共有数百种基因疗法正在开发,开发者当中既有初创公司,也有成名已久的行业领导者。
成功开发基因疗法需要有别于其他生物试剂(比如单抗)生产的专业知识。这种模式需要独特的病毒载体生产和专门的 测试 能力,这也是仅有的能够确定候选生物疗法是否成功的两个领域。由于成熟工艺模板的缺乏、监管指南的变化以及加快项目进度的需要,基因治疗生产商要想一开始就把事情做对,困难重重。
鉴于基因疗法带来的巨大机遇和挑战,与经验丰富的技术伙伴或者合同开发和生产组织(CDMO)联手合作,以确保工艺开发、规模放大、生产和监管合规取得成功,就显得至关重要。
欢迎联系我们获取有关病毒载体生产用生物工艺材料和技术的更多详细信息,我们的专家会第一时间回复您。
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基因治疗制剂开发:培养、纯化、配制
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