One of first Sf-RVN® Insect Cell Line applications for clinical stage gene therapy production

Sf RVN®昆虫细胞系在临床阶段基因治疗生产中的首批应用之一

Merck to support safe and robust production of viral vectors

默克公司将支持病毒载体的安全稳健生产

Collaboration aims to bring new therapies to market faster

合作旨在更快地将新疗法推向市场

Merck, a leading science and technology company, has signed a non-binding Memorandum of Understanding (MoU) with Gene Therapy Research Institution Co., Ltd. (GTRI), a Japanese clinical-stage biotech start-up specializing in gene therapy using adeno-associated virus (AAV) vectors. GTRI will utilize Merck’s Sf-RVN® Insect Cell Line platform for the Good Manufacturing Practices (GMP) production of its viral vector-based gene therapy for Parkinson’s Disease..

领先的科技公司默克公司（Merck）与基因治疗研究所有限公司（GTRI）签署了一份无约束力的谅解备忘录（MoU），该公司是一家日本临床阶段生物技术初创公司，专门从事使用腺相关病毒（AAV）载体进行基因治疗。GTRI将利用默克公司的Sf RVN®昆虫细胞系平台，生产其基于病毒载体的帕金森病基因治疗的良好生产规范（GMP）。。

“In Japan, clinical trials of gene therapy medicines are underway in the hope of developing new treatments to fight and cure diseases,” said Isao Hatano, Head of Process Solutions, Japan, Life Science business of Merck. “With our broad portfolio of products and services, we can better equip and support GTRI in accelerating process development and manufacturing of viral vector-based gene therapy.

“在日本，基因治疗药物的临床试验正在进行中，希望开发新的治疗方法来对抗和治愈疾病，”默克生命科学业务日本过程解决方案负责人Isao Hatano说。“凭借我们广泛的产品和服务组合，我们可以更好地装备和支持GTRI加速基于病毒载体的基因治疗的过程开发和制造。

We believe this collaboration will ultimately help save many patients suffering from serious diseases.”.

我们相信，这种合作最终将有助于挽救许多患有严重疾病的患者。”。

As part of the MoU, Merck will partner with GTRI to build a robust AAV production platform to scale up production. The collaboration will also include the use of Merck’s cell line and platform technologies for developing viral vector-based gene therapy.

作为谅解备忘录的一部分，默克将与GTRI合作，建立一个强大的AAV生产平台，以扩大生产规模。该合作还将包括利用默克公司的细胞系和平台技术开发基于病毒载体的基因疗法。

Additionally, Merck will provide GTRI with technical support, training and process optimization for process development at the M Lab™ Collaboration Center in Tokyo.

此外，默克将在东京的M Lab™协作中心为GTRI提供工艺开发的技术支持、培训和工艺优化。

“Since 2014, we have been working to bring our unique gene therapy techniques to refractory diseases where effective therapies have not been established, primarily focusing on Parkinson's disease and Amyotrophic Lateral Sclerosis (ALS),” said Katsuhito Asai, CEO, GTRI. “Our biggest challenge is developing robust and safe manufacturing processes for viral vectors used to introduce DNA into patients, especially on a large scale.

“自2014年以来，我们一直在努力将我们独特的基因治疗技术应用于尚未建立有效治疗方法的难治性疾病，主要集中在帕金森氏病和肌萎缩侧索硬化症（ALS），”GTRI首席执行官Asai Katsuhito说。“我们最大的挑战是为用于将DNA引入患者的病毒载体开发强大而安全的制造工艺，尤其是大规模的病毒载体。

Producing viral vectors is much more complex and larger in scale than making typical antibody drugs. Our partnership with Merck will optimize this process and help bring therapies to market faster.” .

生产病毒载体比生产典型的抗体药物要复杂得多，规模也更大。我们与默克的合作将优化这一过程，并有助于更快地将治疗方法推向市场。”。