COLUMBUS, Ohio, May 23, 2024 /PRNewswire/ -- Andelyn Biosciences, Inc., a leading and patient-focused cell and gene therapy Contract Development and Manufacturing Organization (CDMO), has been selected to manufacture adeno-associated vectors (AAV) therapies using its suspension AAV Curator™ Platform under the California Institute for Regenerative Medicine (CIRM) Accelerating Medicines Partnership (AMP) Bespoke Gene Therapy Consortium (BGTC)..

俄亥俄州哥伦布，2024年5月23日/PRNewswire/-Andelyn Biosciences，Inc.，一家领先且以患者为中心的细胞和基因治疗合同开发和制造组织（CDMO），已被选中使用加州再生医学研究所（CIRM）加速药物合作伙伴关系（AMP）定制基因治疗联盟（BGTC）下的悬浮AAV Curator™平台制造腺相关载体（AAV）疗法。。

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The CIRM partnership with Andelyn was established to advance BGTC's mission to develop platforms and standards to propel the development and delivery of customized or 'bespoke' gene therapies for millions of people affected with rare diseases. BGTC is focusing on development of cures for eight such diseases, with Andelyn selected to optimize and scale the AAV therapy processes for the treatment of Congenital Hereditary Endothelial Dystrophy – Type 1..

CIRM与Andelyn建立伙伴关系是为了推进BGTC的使命，即开发平台和标准，以推动为数百万患有罕见疾病的人开发和提供定制或“定制”基因疗法。BGTC专注于开发八种此类疾病的治疗方法，安第林被选中来优化和扩大AAV治疗过程，以治疗先天性遗传性内皮营养不良-1型。。

Andelyn Biosciences to manufacture gene therapies using its suspension AAV Curator(TM) Platform for CIRM

Andelyn Biosciences使用其悬浮AAV Curator（TM）平台为CIRM制造基因疗法

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Matt Niloff, Chief Commercial Officer of Andelyn, said: 'As a long-standing pioneer in AAV gene therapies and historical connection to the clinic, we have great synergies with the CIRM/BGTC. Andelyn is privileged to work with the CIRM/BGTC on its first AMP established specifically for rare disease and leverage our AAV Curator™ Platform to help overcome the major obstacles related to developing gene therapies.'.

Andelyn首席商务官马特·尼洛夫（MattNiloff）说：“作为AAV基因疗法的长期先驱以及与临床的历史联系，我们与CIRM/BGTC有着巨大的协同作用。Andelyn有幸与CIRM/BGTC合作开发其第一个专门为罕见疾病建立的AMP，并利用我们的AAV Curator™平台来帮助克服与开发基因疗法相关的主要障碍。”。

Dr. Abla Creasey, PhD, Vice President of Therapeutics Development at CIRM said: 'This partnership with Andelyn will enable progress in the field and help overcome manufacturing obstacles that can potentially lead to breakthroughs for rare diseases like Congenital Hereditary Endothelial Dystrophy.'With exceptional quality and scalable end-to-end development and manufacturing capabilities across its three Columbus, Ohio facilities, Andelyn is enabling the progression of life-altering gene therapies for rare and prevalent diseases.About Andelyn Biosciences, Inc.Andelyn Biosciences is a full-service cell and gene therapy CDMO focused on the development, characterization and production of viral vectors for gene therapy.

CIRM治疗开发副总裁Abla Creasy博士说：“与安第林的合作将在该领域取得进展，并有助于克服制造障碍，这些障碍可能导致先天性遗传性内皮营养不良等罕见疾病的突破。”凭借其俄亥俄州哥伦布市的三家工厂卓越的质量和可扩展的端到端开发和制造能力，安第林正在为罕见和流行疾病的改变生命的基因疗法取得进展。关于Andelyn Biosciences，Inc。Andelyn Biosciences是一家全方位服务的细胞和基因治疗CDMO，专注于基因治疗病毒载体的开发，表征和生产。

With more than 20 years of experience, Andelyn's deep scientific expertise has resulted in the production of cGMP material for more than 450 clinical batches and 75 global clinical trials. Operating out of three Columbus, Ohio facilities, Andelyn supports its clients in developing cell and gene therapies from concept through plasmid engineering and manufacturing, process and analytical development, and cGMP clinical and commercial manufacturing.

凭借20多年的经验，Andelyn拥有深厚的科学专业知识，已经为450多个临床批次和75个全球临床试验生产了cGMP材料。Andelyn在俄亥俄州哥伦布的三家工厂运营，支持其客户开发细胞和基因疗法，从概念到质粒工程和制造，过程和分析开发，以及cGMP临床和商业制造。

Andelyn can accelerate programs and deliver high quality products by developing and manufacturing processes on its configurable, data-driven AAV Curator™ Platform, or tech transfer in an established client program. Capabilities include cGMP manufacturing for both adherent and suspension processes up to a 2,000-liter capacity.

Andelyn可以通过在其可配置、数据驱动的AAV Curator™平台上开发和制造流程，或者在已建立的客户计划中进行技术转让，从而加速计划并提供高质量的产品。能力包括用于粘附和悬浮过程的cGMP制造，容量高达2000升。

A rigorous quality system, regulatory support and supply chain vertical integration further support clients in bringing their critical therapies to market. For more information, visit andelynbio.com.About the California Institute for Regenerative Medicine (CIRM)At CIRM, we never forget that we we.

严格的质量体系、监管支持和供应链垂直整合进一步支持客户将其关键疗法推向市场。有关更多信息，请访问andelynbio.com.About the California Institute For Regenerative Medicine（CIRM）At CIRM，我们永远不会忘记我们。