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LONDON, UK, October 15, 2025 /
英国伦敦,2025年10月15日 /
Biotech Newswire
生物技术新闻专线
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Touchlight
触光
, a leader in synthetic DNA manufacturing, announced today the use of its proprietary
,一家合成DNA制造领域的领导者,今天宣布了其专有技术的使用
z- dbDNA™
z- dbDNA™
technology as a critical starting material in the manufacture of a cutting-edge gene therapy in a US-based clinical study.
技术作为在美国临床研究中制造前沿基因疗法的关键起始材料。
This development underscores the transformative potential of dbDNA in driving the development of safe, effective, and scalable therapies. It follows Touchlight’s receipt in 2025 of a GMP certificate for the production of dbDNA at its state-of-the-art facility in Hampton, UK. dbDNA’s unique design, a linear, closed-end DNA construct free of bacterial sequences, ensures high purity and stability, making it an ideal platform for gene therapy applications..
这一进展突显了dbDNA在推动安全、有效且可扩展疗法开发方面的变革潜力。此前,Touchlight于2025年在其位于英国汉普顿的先进设施中获得了用于生产dbDNA的GMP证书。dbDNA的独特设计是一种不含细菌序列的线性、闭端DNA结构,确保了高纯度和稳定性,使其成为基因治疗应用的理想平台。
The senior scientist working on this clinical study, said:
这项临床研究的资深科学家表示:
“Touchlight’s z- dbDNA platform provided the high-purity DNA material, scalable production capabilities, and rapid turnaround necessary to advance our gene therapy program. The team demonstrated technical responsiveness and a solution-driven approach, facilitating sequence delivery and production support within a compressed timeline.
“Touchlight的z-dbDNA平台提供了高纯度的DNA材料、可扩展的生产能力以及快速的周转时间,这些是我们基因治疗项目推进所必需的。该团队展现了技术上的响应能力和以解决方案为导向的方法,在压缩的时间表内促进了序列交付和生产支持。”
Communication was consistently clear, and batch release testing met all delivery and quality expectations”..
沟通始终清晰,批次放行测试满足所有交付和质量预期。
Unlike conventional plasmid DNA, dbDNA is manufactured using a cell-free process that is faster and more scalable, whilst eliminating the risk of antibiotic resistance or other unwanted contaminants. These characteristics of dbDNA align with regulatory guidelines and the growing need for safer, more efficient biomanufacturing processes..
不同于传统的质粒 DNA,dbDNA 采用无细胞工艺制造,速度更快、可扩展性更高,同时消除了抗生素耐药性或其他不需要的污染物的风险。dbDNA 的这些特性符合监管指南,并满足对更安全、更高效的生物制造工艺日益增长的需求。
Touchlight remains committed to empowering researchers and biopharmaceutical companies with the tools they need to push the boundaries of genetic medicine. The company’s ongoing collaborations and innovations continue to support the development of life-changing therapies for patients worldwide.
Touchlight 仍致力于为研究人员和生物制药公司提供推动基因药物边界所需的工具。该公司持续的合作与创新不断支持着为全球患者开发改变生命的疗法。
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About
关于
Touchlight
触光
Touchlight is a leading innovation-driven CDMO pioneering enzymatic GMP DNA production to enable the genetic medicine revolution. Founded in 2007 and inspired by breakthroughs in genetic medicine, Touchlight’s team has built a business and technology platform which recognised and addresses the urgent need for innovative DNA production techniques to support the future of genetic therapies..
Touchlight 是一家领先的创新驱动型 CDMO,率先采用酶促 GMP DNA 生产技术,助力基因医学革命。公司成立于 2007 年,受基因医学突破的启发,Touchlight 的团队构建了一个业务与技术平台,认识到并解决了对创新 DNA 生产技术的迫切需求,以支持基因疗法的未来发展。
As sector leaders, with an FDA Drug Master File accepted in 2022 and having been awarded the world’s first cell-free DNA GMP license in 2025, Touchlight’s enzymatic DNA technology is at the cutting edge for AAV, mRNA, DNA vaccine, and gene editing technologies.
作为行业领导者,Touchlight 的酶促 DNA 技术在 2022 年获得了 FDA 药品主文件批准,并于 2025 年荣获全球首个无细胞 DNA GMP 许可证,处于 AAV、mRNA、DNA 疫苗和基因编辑技术的最前沿。
Touchlight’s state-of-the-art facility was recognised in 2025 by ISPE’s Facility of the Year Awards (FOYA) for Innovation.
Touchlight 的先进设施在 2025 年被 ISPE 年度最佳设施奖 (FOYA) 授予创新奖项。
With multiple client products already in the clinic, Touchlight’s proven synthetic DNA manufacturing solutions offer a scalable, sustainable alternative to plasmid DNA (pDNA) for all stages of pre-clinical, clinical and commercial development.
凭借多种客户产品已进入临床阶段,Touchlight经验证的合成DNA制造解决方案为临床前、临床和商业开发的所有阶段提供了一个可扩展且可持续的质粒DNA(pDNA)替代方案。
The business and technology of Touchlight are built on the conviction that DNA is fundamental to the future of medicine. Traditional methods, based on bacterial fermentation, are generally considered to be slow, costly and unable to meet the growing demands of genetic medicine due to limited scalability and speed..
Touchlight 的业务和技术建立在这样一个信念之上:DNA 对于医学的未来至关重要。基于细菌发酵的传统方法通常被认为速度慢、成本高,并且由于可扩展性和速度有限,无法满足基因药物不断增长的需求。
Contact
联系
Touchlight
触光
Karen Fallen, Chief Executive Officer
凯伦·法伦,首席执行官
This email address is being protected from spambots. You need JavaScript enabled to view it.
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+44 20 8481 9200
+44 20 8481 9200
Keywords: Plasmids; DNA; Genetic Therapy; Technology; Nucleic Acids; Gene Editing; United Kingdom; Touchlight; z-dbDNA technology; synthetic DNA manufacturing; gene therapy; dbDNA; GMP certificate; bacterial sequence-free DNA; high purity DNA; gene therapy applications; scalable DNA production; batch release testing; plasmid DNA alternative; cell-free DNA manufacturing; antibiotic resistance-free DNA; biomanufacturing; regulatory compliance; genetic medicine; CDMO (Contract Development and Manufacturing Organization); enzymatic GMP DNA production; cell-free DNA GMP license.
关键词:质粒;DNA;基因治疗;技术;核酸;基因编辑;英国;Touchlight;z-dbDNA 技术;合成 DNA 制造;基因治疗;dbDNA;GMP 证书;无细菌序列 DNA;高纯度 DNA;基因治疗应用;可扩展 DNA 生产;批次放行测试;质粒 DNA 替代品;无细胞 DNA 制造;无抗生素耐药性 DNA;生物制造;法规合规;遗传医学;CDMO(合同开发与制造组织);酶促 GMP DNA 生产;无细胞 DNA GMP 许可证。
Source: Biotech Newswire
来源:生物技术新闻社