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2025/05/16 / Company Events and News
楷拓荣誉 | 连续三年蝉联未来医疗100强
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楷拓荣誉 | 连续三年蝉联未来医疗100强
2025/05/16

动脉网2025未来医疗100强榜单于近日重磅揭晓,楷拓生物连续三年强势入围“中国医疗健康产业链服务榜TOP 100”。作为医疗健康产业最具公信力的年度评选之一,未来医疗100强主榜以严谨的VB100评估模型,从创新性、成长性、市场表现等多维度甄选行业标杆。连续三年入选,不仅彰显了楷拓生物在CGT与核酸药物CRDMO领域的技术领先地位,更凸显行业对公司一站式服务平台和国际化交付能力的高度认可。

楷拓生物依托行业领先的质粒、RNA和LNP三大技术平台,为全球客户提供专业的核酸药物解决方案。

楷拓生物开发了长polyA尾与连续裂解工艺,显著提升质粒DNA的生产效率与产品质量。单批次生产可达克级规模,超螺旋单体比例超95%,杂质限度低。目前,公司已成功生产30余批克级GMP质粒,序列完整性高、表达量优异,为mRNA、DNA疫苗药物及基因疗法的下游工艺开发提供了高品质原材料,奠定坚实基础。

楷拓生物的RNA平台支持从毫克级到百克级的IVT生产,覆盖线性mRNA、环状RNA、自复制RNA等多种复杂核酸分子。通过专利dsRNA去除工艺,平台可实现>90%的核酸纯度,并有效控制双链RNA副产物(<100 ng/mg)。此外,平台整合了化学修饰与序列优化技术,显著提升RNA分子的稳定性和翻译效率,适用于疫苗、肿瘤新抗原疗法及基因编辑递送系统。

楷拓生物的LNP平台融合微流控技术与自主研发的Max Mix™对撞流技术,实现高效、均一的纳米颗粒包封(包封率>95%,PDI<0.1)。平台依托与全球领先的阳离子脂质供应商合作的专利资源,开发了多样化的LNP递送系统,包括非肝靶向递送及LNP-抗体偶联(LNP-Ab)创新技术,为mRNA、siRNA及基因编辑工具的精准递送提供解决方案。平台支持从实验室规模到kg级LNP包裹,满足不同阶段的工艺需求。

面对复杂的国际供应链环境,楷拓生物依托中美欧三地研发与生产基地,构建了高效的跨国协作网络。公司GMP生产体系严格遵循FDA、EMA和NMPA的监管标准,覆盖从工艺开发到商业化生产的全部环节,确保产品合规性与可追溯性。迄今为止,楷拓生物已累计服务超300家全球客户,涵盖传统疫苗公司、制药巨头、生物技术公司。

楷拓生物核心团队在核酸药物领域具备深厚专业背景,拥有丰富的中美双报经验。凭借模块化CMC策略,公司高效支持客户在预防型疫苗、治疗型疫苗、肿瘤新抗原药物、蛋白替代、细胞疗法及基因编辑疗法等领域的管线开发与监管申报,助力客户应对供应链本土化与国际化合规的双重挑战。

三载荣光,不忘初心。楷拓生物将持续以“技术引领+产业赋能”双轮驱动,为生物医药创新注入高效、可靠的产业化动能,与全球伙伴共拓核酸药物黄金时代。

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楷拓生物MaxMix工艺成功实现近 20g mRNA-LNP稳定生产验证
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