VGXI成功完成FDA检查，助力客户BLA批准里程碑，进一步巩固其在质粒DNA制造领域的领导地位-动脉网

VGXI Completes Successful FDA Inspection Enabling Client BLA Approval Milestone, Advancing Its Leadership in Plasmid DNA Manufacturing

CISION 等信源发布 2025-05-12 22:28

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CONROE, Texas

康罗，德克萨斯州

，

May 13, 2025

2025年5月13日

/PRNewswire/ -- VGXI, Inc., a leading contract development and manufacturing organization (CDMO) specializing in plasmid DNA biopharmaceuticals, including for use in gene therapies, DNA vaccines, and RNA medicines, proudly announces it has recently completed a successful inspection by the US FDA at its GMP manufacturing facility, resulting in the approval of the client's Biologics License Application (BLA).

/PRNewswire/ -- VGXI, Inc.是一家领先的合同开发和制造组织（CDMO），专注于质粒DNA生物制药，包括用于基因治疗、DNA疫苗和RNA药物的领域，自豪地宣布其GMP制造设施最近成功通过了美国FDA的检查，并促使其客户的生物制品许可申请（BLA）获得批准。

This milestone reinforces VGXI's long-standing commitment to regulatory excellence, product quality, and client success in bringing novel therapies to market..

这一里程碑进一步巩固了VGXI长期以来对监管卓越、产品质量和客户成功的承诺，将创新疗法推向市场。

Building upon over two decades of experience, the successful regulatory inspection recognizes VGXI's robust quality systems and proven capabilities in manufacturing plasmid DNA utilized in the development and commercialization of cell and gene therapies. As VGXI's third commercial phase program since 2019, it highlights the CDMO's history of supporting marketed products and meeting rigorous global regulatory standards.

基于二十多年的经验，成功的监管检查认可了VGXI在生产用于细胞和基因治疗开发与商业化的质粒DNA方面强大的质量体系和经过验证的能力。作为VGXI自2019年以来的第三个商业阶段项目，这突显了CDMO在支持上市产品和满足严格的全球监管标准方面的历史。

With this achievement, VGXI continues to set the benchmark for reliability and innovation in plasmid DNA manufacturing..

通过这一成就，VGXI继续在质粒DNA制造的可靠性和创新性方面树立基准。

Young Park

尹英公园

, CEO of VGXI, stated, 'This FDA inspection is not just a validation of our facility — it is a testament to our team's unwavering commitment to quality and our partners. Our clients trust us with their most promising programs, and this milestone enhances our ability to help them accelerate timelines, reduce regulatory risk, and bring life-changing medicines to patients faster.'.

VGXI首席执行官表示：“此次FDA的检查不仅是对我们设施的认可，更是对我们团队始终如一地致力于质量和合作伙伴关系的证明。我们的客户将他们最有前景的项目托付给我们，这一里程碑增强了我们帮助他们加快进度、降低监管风险并将改变生命的药物更快带给患者的能力。”

FDA regulatory inspections serve as a critical measure of a CDMO's ability to meet the most stringent requirements for safety and efficacy. Supporting the client's successful BLA approval by the FDA reaffirms VGXI's continuous improvement culture and inspection readiness. The company has adopted best practices seen across leading industry peers — including proactive quality systems, rigorous documentation, unmatched expansion capacity, and real-time compliance visibility..

FDA监管检查是衡量CDMO能否满足最严格的安全性和有效性要求的关键标准。协助客户成功获得FDA的BLA批准再次证实了VGXI持续改进的文化和应对检查的准备就绪能力。该公司采用了业界领先同行的最佳实践——包括主动的质量体系、严格的文件管理、无与伦比的扩展能力以及实时合规可见性。

ABOUT VGXI, INC.

关于VGXI公司

VGXI is a leader in plasmid DNA contract manufacturing, with 20+ years of experience providing high-quality products to biomedical researchers worldwide. We support clients that develop DNA vaccines, immunotherapies, cell therapies, and gene therapies. VGXI's manufacturing process and quality controls are coupled to a continuous, low-shear AIRMIX® patented lysis technology, and proprietary purification processes that provide highly supercoiled plasmid production and exceptional purity.

VGXI是质粒DNA合同制造的领导者，拥有20多年的经验，为全球生物医学研究人员提供高质量的产品。我们支持开发DNA疫苗、免疫疗法、细胞疗法和基因疗法的客户。VGXI的生产工艺和质量控制结合了连续、低剪切的AIRMIX®专利裂解技术，以及提供高超螺旋质粒生产和卓越纯度的专有纯化工艺。

VGXI's portfolio includes high-quality plasmid for preclinical research, Highly Documented (HD) plasmid as a critical raw material for GMP viral vector production or pharm/tox studies, cGMP plasmid DNA for clinical utilization through commercial supply, and custom services. .

VGXI的产品组合包括用于临床前研究的高质量质粒、作为GMP病毒载体生产或药理/毒理研究关键原料的高度文档化（HD）质粒、用于临床应用及商业供应的cGMP质粒DNA，以及定制服务。

https://www.vgxii.com

。

CONTACT:

联系人：

Justin Smith

贾斯汀·史密斯

, Director of Marketing,

，营销总监，

jcsmith@vgxii.com

。

SOURCE VGXI, Inc.