为基因遗传疾病提供治疗新途径，Cytiva与正序生物合作开发基因编辑创新疗法工艺平台

新闻晨报2025-07-14

7月14日，全球科学与技术的创新者丹纳赫在沪宣布其旗下运营公司Cytiva思拓凡与正序生物开展战略合作，共同开发基于脂质纳米颗粒递送系统的基因治疗创新工艺解决方案，以推动基因编辑技术在遗传性疾病治疗领域的突破。这也是丹纳赫第一次携手中国生物技术企业开展Danaher Beacon合作。基因遗传性疾病是由基因突变引起，包括镰刀型贫血症、囊性纤维化、杜氏肌营养不良等数千种疾病。绝大部分基因遗传性疾病...

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Beacon合作。基因遗传性疾病是由基因突变引起，包括镰刀型贫血症、囊性纤维化、杜氏肌营养不良等数千种疾病。绝大部分基因遗传性疾病目前尚无药可医，其中小部分病种患者往往需要终生服药。近年来在医学领域，基因编辑技术的进步为基因遗传疾病的治疗带来新希望。正序生物开发的单碱基基因编辑技术具有高精度、低脱靶的特性，能够在庞大的基因组中精准、永久地改变单个碱基对，为基因突变引起的遗传性疾病治愈提供了新的可能。然而，要实现碱基编辑技术在基因治疗中的临床应用，还需突破组织递送、规模化生产及质量控制等关键瓶颈。正序生物首席执行官牟晓盾正序生物首席执行官牟晓盾表示：“目前我们原创的碱基编辑技术已治愈近20例β-地中海贫血症和镰刀型细胞贫血患者。依托丹纳赫集团的全球平台资源与Cytiva丰富的LNP（脂质纳米颗粒）与AAV载体库，我们将加速构建体内递送平台。Cytiva符合国际标准的GMP生产平台更将与我们创新基因编辑平台优势互补，显著缩短开发和上市周期。面向未来，双方将聚焦高甘油三酯血症、高胆固醇血症等慢性代谢疾病，有望通过一次性基因治疗实现长期指标控制，为中国和全球患者提供更具颠覆性的治疗选择。”丹纳赫中国首席科学官方焯丹纳赫中国首席科学官方焯解释：“此次合作中，丹纳赫将从技术和质量控制两方面为正序生物赋能：一是利用Cytiva基因编辑疗法工艺开发平台，涵盖寡核苷酸合成、mRNA体外生产、LNP封装等工艺技术，切实推动基因疗法从技术研发到规模化生产和临床应用。这对正序生物的下一代体内编辑的治疗方法至关重要。二是引入丹纳赫的质谱、色谱和流式技术，在合成及递送过程中的每一步进行质量控制，确保流程完整、质量可靠。此次是Danaher Beacon项目在中国与本土先进生物技术企业的首次合作。未来，我们希望在更广泛的科研和创新转化领域与本土顶尖学者、头部学术和医疗机构、创新技术企业合作，借助丹纳赫的成熟技术及工艺加速推进临床应用，造福更多中国和全球患者。”正序生物将与Cytiva合作，结合Cytiva的先进生物制造平台，以及贝克曼库尔特生命科学、艾杰尔飞诺美检测技术平台，共同开发全流程生产工艺技术平台，加速基因编辑技术在临床上的转化应用，为基因编辑疗法的产业化提供创新解决方案。这是丹纳赫集团落地中国的又一Danaher Beacon项目。Danaher Beacon项目是丹纳赫联合顶级学术机构、科研院在全球发起的一项前沿科学研究计划，旨在开展前沿性的科学研究，开发改善人类健康的创新技术和应用。项目专注基因组药物、精准诊断、下一代生物制品制造、人类系统和数据科学等。位于上海张江的Cytiva中国科创中心将为此次基因编辑疗法创新提供工艺开发和规模化生产等核心技术支持。该中心拥有全亚洲最大的模块化生物工艺工作站，可提供核酸药物制备、脂质纳米颗粒配方筛选、微流控包封工艺优化到cGMP级放大的全流程开发服务，目前已累计完成数十项基因治疗工艺开发项目。凭借在mRNA与脂质纳米颗粒领域的成熟开发和应用经验，其成为本次Danaher Beacon项目的重要工艺开发基地。Cytiva中国总裁李蕾指出：“Cytiva在中国致力于帮助本土生物技术公司加速从技术研发到规模化生产和临床应用的转化进程，同时支持他们让更多具有自主知识产权的创新疗法尽早造福患者。我们希望通过本次与正序的合作为未来提供可复制的成功范式，从而支持中国基因治疗产业生态的建设，提升国内生物医药产业整体创新能力和国际竞争力。”","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"corporation","news_rank":0,"symbols":[],"gpt_button":1,"need_auth":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; 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