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Charles River推出Lentivation平台以加快基于LVV的基因治疗生产

Charles River Unveils Lentivation Platform to Expedite LVV-based Gene Therapy Manufacturing

businesswire 等信源发布 2023-09-26 17:57

可切换为仅中文


WILMINGTON, Mass.--(BUSINESS WIRE)--Charles River Laboratories International, Inc. (NYSE: CRL) today announced the launch of its lentiviral vector (LVV) manufacturing platform, Lentivation™. The platform has the capability to reduce LVV manufacturing timelines for gene and gene-modified cell therapies by up to 60 percent, translating to fewer than seven months compared to traditional manufacturing workflows..

马萨诸塞州威尔明顿-查尔斯河实验室国际公司(NYSE:CRL)今天宣布推出其慢病毒载体(LVV)制造平台Lentivation™. 该平台能够将基因和基因修饰细胞疗法的LVV制造时间表减少高达60%,与传统制造工作流程相比,可缩短不到7个月。。

Charles River provides viral vector production services ranging from clone construction through good manufacturing practice (GMP) for clinical trials or commercial use and offers a dedicated portfolio to meet customer specific needs such as regulatory requirements or product characteristics, with stringent, in-house quality control adhering to the highest standards of purity and potency..

查尔斯河提供病毒载体生产服务,从克隆构建到临床试验或商业用途的良好生产规范(GMP),并提供专门的组合,以满足客户特定的需求,如监管要求或产品特性,严格的内部质量控制坚持最高的纯度和效力标准。。

Meeting growing client needs for clinical and commercial supply, Lentivation leverages Charles River’s robust screening toolbox for tackling challenging gene-of-interest plasmids, off-the-shelf (OTS) LVV packaging plasmids, phase-appropriate production with fit-for-purpose facilities, on-hand materials, and in-house analytics..

为了满足日益增长的客户对临床和商业供应的需求,Lentivation利用Charles River强大的筛选工具箱来应对具有挑战性的感兴趣基因质粒,现成(OTS)LVV包装质粒,适合用途的设施进行阶段性生产,手上材料,和内部分析。。

Gene Therapy CDMO Services

基因治疗CDMO服务

With over 20 years of viral vector contract development and manufacturing organization (CDMO) expertise and validated platform processes with a proven track record, Charles River has standardized protocols for cell culture, transfection, and downstream purification. These high-yield, optimized methods increase speed to clinical manufacturing by reducing process development time and costs while ensuring high quality production..

查尔斯河拥有20多年的病毒载体合同开发和制造组织(CDMO)专业知识和经过验证的平台流程,并具有可靠的记录,拥有用于细胞培养,转染和下游纯化的标准化方案。这些高产,优化的方法通过减少工艺开发时间和成本,同时确保高质量生产,提高了临床制造的速度。。

The addition of Lentivation follows the launch of Charles River’s OTS LVV packaging and AAV pHelper plasmids, and eXpDNA™ plasmid manufacturing platform, aimed at supporting both LVV-based and AAV-based gene therapy programs. Lentivation also complements the nAAVigation™ platform announced previously, further bolstering Charles River’s cell and gene therapy manufacturing capabilities..

随着查尔斯河OTS LVV包装和AAV pHelper质粒以及eXpDNA的推出,增加了Lentivation™ 质粒制造平台,旨在支持基于LVV和基于AAV的基因治疗计划。Lentivation也是nAAVigation的补充™ 此前宣布的平台,进一步支持了查尔斯河的细胞和基因治疗制造能力。。

These offerings have been established over decades of plasmid DNA and viral vector CDMO scale-up experience which, combined with the Company’s in-house testing capabilities, significantly reduces production turnaround time for advanced therapy medicinal product (ATMP) and vaccine developers.

这些产品已经建立了数十年的质粒DNA和病毒载体CDMO放大经验,结合公司的内部测试能力,显着缩短了高级治疗药品(ATMP)和疫苗开发人员的生产周转时间。

The Lentivation platform will be presented during the BioInsight’s Expert Roundtable: Exploring current and future trends in lentiviral vector manufacturing featuring Ramin Baghirzade, PhD, Senior Director, Global Head Commercial, Gene Therapy CDMO Services on September 27, 2023, at 11:00 am EDT.

Lentivation平台将在BioInsight专家圆桌会议上发表:探索慢病毒载体制造的当前和未来趋势,于2023年9月27日上午11:00,以Ramin Baghirzade博士,全球商业基因治疗CDMO服务高级总监为特色EDT。

Approved Quotes

批准的报价

“We are thrilled to add the Lentivation platform to our robust portfolio of existing capabilities. Our LVV manufacturing offerings allow us to further support advanced therapy programs and, most importantly, deliver novel gene therapies to patients across the globe.' - Kerstin Dolph, Corporate Senior Vice President, Biologics Solutions, Charles River.

“我们很高兴将Lentivation平台添加到我们强大的现有功能组合中。我们的LVV制造产品使我们能够进一步支持先进的治疗计划,最重要的是,为全球患者提供新的基因治疗。”Kerstin Dolph,Charles River生物制剂解决方案公司高级副总裁。

“Charles River’s LVV platform provides a streamlined, reliable path for therapeutic developers to clinic and commercial. The proven platform builds on Charles River’s established capabilities and processes, fine-tuned over decades spent successfully supporting advanced therapy clients.” - Beth Tebeau, Site Director, Rockville, MD, Charles River.

“Charles River的LVV平台为治疗开发人员提供了一条简化,可靠的临床和商业路径。经过验证的平台建立在Charles River已建立的能力和流程之上,经过数十年的微调,成功支持高级治疗客户。”Beth Tebeau,Charles River医学博士Rockville现场总监。

About Charles River

关于查尔斯河

Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them.

查尔斯河提供必要的产品和服务,帮助制药和生物技术公司,政府机构和全球领先的学术机构加速他们的研究和药物开发工作。我们的专职员工专注于为客户提供他们需要改进的内容,并为需要他们的患者加快发现,早期开发和安全制造新疗法。

To learn more about our unique portfolio and breadth of services, visit www.criver.com..

要了解更多有关我们独特的产品组合和广泛的服务,请访问www.criver.com。。