Collaboration provides end-to-end coverage of mRNA drug and vaccine development and manufacturing workflow

合作提供mRNA药物和疫苗开发和制造工作流程的端到端覆盖

HOUSTON and NEEDHAM, Mass., Sept. 19, 2023 /PRNewswire/ -- PackGene Biotech (PackGene) and Kudo Biotechnology (Kudo Bio) have partnered to provide high-quality, customized messenger RNA (mRNA) manufacturing services for drug and vaccine development. The global collaboration, announced today at the BioProcess International (BPI) Conference & Exhibition in Boston, provides end-to-end coverage of mRNA development, from gene to mRNA, lipid nanoparticle (LNP) formulation development and encapsulation, through to fill-finished drug product, under good manufacturing practice (GMP) guidelines..

HOUSTON和NEEDHAM，Mass。，2023年9月19日/PRNewswire/-PackGene Biotech（PackGene）和Kudo Biotechnology（Kudo Bio）合作为药物和疫苗提供高质量，定制的信使RNA（mRNA）制造服务发展。今天在波士顿生物过程国际（BPI）会议和展览上宣布的全球合作提供了从基因到mRNA，脂质纳米粒子（LNP）制剂开发和封装，到填充成品的mRNA开发的端到端覆盖药品，符合良好生产规范（GMP）指南。。

PackGene, a contract research organization (CRO) and contract development and manufacturing organization (CDMO), has expanded its services to support mRNA drug development. By partnering with Kudo Bio, an mRNA and LNP CDMO, both companies aim to provide custom mRNA GMP manufacturing with industry-leading timelines, superior quality, stellar performance, and comprehensive analytical panels in a streamlined manner.

合同研究组织（CRO）和合同开发与制造组织（CDMO）PackGene已经扩展其服务以支持mRNA药物开发。通过与mRNA和LNP CDMO的Kudo Bio合作，两家公司的目标是以行业领先的时间表，卓越的质量，卓越的性能和简化的综合分析面板提供定制的mRNA GMP制造。

Under terms of the partnership, PackGene will provide process development and manufacturing services for plasmid DNA (pDNA) and cell banking, and Kudo Bio will provide process development, analytical development, and manufacturing of mRNA and LNP, as well as fill and finish..

根据合作条款，PackGene将为质粒DNA（pDNA）和细胞库提供过程开发和制造服务，Kudo Bio将提供mRNA和LNP的过程开发，分析开发和制造，以及填充和完成。。

The collaboration offers a one-stop platform for mRNA and LNP production, including pDNA production and cell banking, mRNA synthesis, LNP encapsulation and formulation development, GMP batch release and certificates of analysis, fill and finish, and investigational new drug (IND) filing assistance. PackGene and Kudo Bio both highly prioritize regulatory compliance and offer a quality management system that meets global regulatory standards..

该合作为mRNA和LNP生产提供了一站式平台，包括pDNA生产和细胞库，mRNA合成，LNP封装和配方开发，GMP批次发布和分析证书，填充和完成以及研究性新药（IND）归档协助。PackGene和Kudo Bio都高度重视监管合规性，并提供符合全球监管标准的质量管理体系。。

'With our combined expertise in process and analytical development and GMP facilities operations, we offer our clients a seamless transition from development to manufacturing and access to unparalleled expertise, professionalism, and convenience in pDNA, mRNA, and LNP production,' said PackGene Chief Strategy Officer Xin Swanson..

PackGene首席执行官Xin Swanson说：“凭借我们在过程和分析开发以及GMP设施运营方面的综合专业知识，我们为客户提供了从开发到制造的无缝过渡，并获得无与伦比的专业知识，专业性和pDNA，mRNA和LNP生产的便利性。。

Customized process and analytical development for DNA templates, mRNA drug substances, and drug products is performed at the companies' Manufacturing Sciences and Analytical Technology (MSAT) laboratories to optimize each project's potential. The extensive analytical panel for pDNA, mRNA, and LNP provides valuable insights that allow for bespoke in-process control, release testing, and stability studies.

在公司的制造科学与分析技术（MSAT）实验室进行DNA模板，mRNA药物和药品的定制工艺和分析开发，以优化每个项目的潜力。针对pDNA，mRNA和LNP的广泛分析小组提供了有价值的见解，可以进行定制的过程控制，释放测试和稳定性研究。

The rigorous quality control processes ensure that products meet and exceed the highest global standards, comparable to renowned CDMOs. Kudo Bio assists clients with mRNA development and production, with a client notably receiving clinical trial authorization of one of its GMP mRNA products by both HSA Singapore and TGA Australia..

严格的质量控制流程确保产品达到并超过全球最高标准，与知名的CDMO相当。Kudo Bio协助客户进行mRNA开发和生产，客户特别是接受HSA Singapore和TGA Australia对其GMP mRNA产品之一的临床试验授权。。

'The collaboration between PackGene Biotech and Kudo Biotechnology will help to meet the growing demand for customized mRNA and LNP production services,' said Molly S. McGlaughlin, CEO of Kudo Bio. 'By providing a one-stop solution across the entire workflow of mRNA drug and vaccine development, we offer a streamlined process to ensure efficiency and reliability in CMC while delivering superior quality that exceeds the highest global industry standards.'.

“PackGene Biotech和Kudo Biotechnology之间的合作将有助于满足对定制mRNA和LNP生产服务日益增长的需求，”Kudo Bio首席执行官Molly S.McLaughlin说。通过在mRNA药物和疫苗开发的整个工作流程中提供一站式解决方案，我们提供简化的流程，以确保CMC的效率和可靠性，同时提供超过全球最高行业标准的卓越质量。

About PackGene Biotech

关于PackGene Biotech

PackGene Biotech is a leading CDMO that specializes in the production of plasmid DNA for mRNA production. Their GMP plasmid production site, located in Guangzhou, China, is dedicated to providing reliable, compliant, and scalable plasmid production services.  With its reliability, scalability, and compliance, PackGene's facility provides high-quality plasmid production services that exceed industry standards and a specialized process for mRNA IVT templates..

PackGene Biotech是一家领先的CDMO，专门生产用于mRNA生产的质粒DNA。他们位于中国广州的GMP质粒生产基地致力于提供可靠，合规，可扩展的质粒生产服务。凭借其可靠性，可扩展性和合规性，PackGene的工厂提供高质量的质粒生产服务，超越了行业标准和mRNA IVT模板的专门流程。。

PackGene is renowned for its proprietary π-Alpha™ 293 AAV High-Yield Platform, a triple-plasmid transfection system that uses uniquely designed RC plasmid to increase AAV production by three to eight times in various AAV serotypes. PackGene provides economical, reliable, and scalable plasmid DNA and AAV viral vector production for early-stage drug discovery, preclinical development, and clinical trials for Cell and Gene Therapy (CGT).

PackGene以其专有的π-Alpha而闻名™ 293 AAV高产平台，一种三重质粒转染系统，使用独特设计的RC质粒在各种AAV血清型中将AAV产量增加3至8倍。PackGene为细胞和基因治疗（CGT）的早期药物发现，临床前开发和临床试验提供经济，可靠和可扩展的质粒DNA和AAV病毒载体生产。

For more information, please visit www.packgene.com..

欲了解更多信息，请访问www.packgene.com。。

About Kudo Biotechnology

关于工藤生物技术

Kudo Biotechnology is a leading global mRNA CDMO, providing world-class, end-to-end mRNA manufacturing solutions, all under one roof. Kudo Bio has a state-of-the-art clinical GMP manufacturing facility and MSAT laboratories in Shanghai, with additional presence in Boston and Singapore. Their GMP manufacturing facility spans over 57,000 sqf and is designed in accordance with cGMP and global regulatory guidelines, featuring 2 plasmid lines, 3 mRNA lines, 2 LNP bulk lines, and 1 drug product fill & finish line.

Kudo Biotechnology是领先的全球mRNA CDMO，提供世界一流的端到端mRNA制造解决方案，全部在一个屋顶下。Kudo Bio在上海拥有最先进的临床GMP生产设施和MSAT实验室，并在波士顿和新加坡设有。他们的GMP生产设施跨度超过57000平方英尺，按照cGMP和全球监管指南设计，具有2条质粒系，3条mRNA系，2条LNP散装线和1条药品填充和终点线。

Kudo Bio's production lines cater to manufacturing needs for preclinical through Phase 2 clinical trials, with the capacity to manufacture up to 40 million vials/year for Phase 3 and commercial manufacturing. Their cutting-edge equipment is customized for mRNA and LNP drug development, and they offer a range of additional services, including Process and Analytical Development, Technology Transfer, Fill & Finish, Testing & Release, and Supply Chain Management..

Kudo Bio的生产线通过2期临床试验满足临床前的制造需求，为3期和商业制造提供高达4000万瓶/年的生产能力。他们的尖端设备专为mRNA和LNP药物开发而定制，并提供一系列附加服务，包括过程和分析开发，技术转让，填充和完成，测试和发布以及供应链管理。。

Kudo Bio provides comprehensive solutions for their clients' drug development needs and has a robust QMS to ensure the highest quality and to comply with global regulations. Kudo Bio is expanding its presence in the United States, with a process development laboratory currently under construction in Needham, MA.

Kudo Bio为客户的药物开发需求提供全面的解决方案，并拥有强大的质量管理体系，以确保最高质量并遵守全球法规。工藤生物正在扩大其在美国的存在，目前正在马萨诸塞州尼德姆建造一个过程开发实验室。

For more information, please visit www.kudobio.com..

欲了解更多信息，请访问www.kudobio.com。。

CONTACTS

联络

PackGene BiotechIrene Song, PhDSr. Director, Global Product[email protected]

PackGene BiotechIrene Song，博士。全球产品总监[电子邮件保护]

Kudo BiotechnologyKelvin Chan, PhDDirector, Business Development[email protected]

Kudo BiotechnologyKelvin Chan，PhD Rector，业务开发[电子邮件保护]

For Media

对于媒体

Susan ThomasEndpoint Communicationssusan@endpointcommunications(619) 540-9195

苏珊·托马森德PointCommunicationssusan@endpointcommunications(619) 540-9195

SOURCE Packgene

来源Packgene