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Charles River启动病毒载体技术转让计划以保障基因治疗的发展

Charles River Launches Viral Vector Tech Transfer Program to Safeguard Gene Therapy Development

businesswire 2024-05-30 18:00 翻译由动脉网AI生成,点击反馈

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WILMINGTON, Mass.--(BUSINESS WIRE)--Charles River Laboratories International, Inc. (NYSE: CRL) today announced the introduction of its Modular and Fast Track viral vector technology (tech) transfer frameworks. Based on decades of viral vector contract development and manufacturing organization (CDMO) experience, the Company has designed a methodical program to drive successful, accelerated process transfer to its Maryland-based viral vector center of excellence (CoE) in as little as nine months..

马萨诸塞州威尔明顿(商业新闻短讯)--查尔斯河实验室国际公司(纽约证券交易所:CRL)今天宣布推出其模块化和快速病毒载体技术(tech)转移框架。基于数十年的病毒载体合同开发和制造组织(CDMO)经验,该公司设计了一个有条不紊的计划,以在短短九个月内将其成功、加速的过程转移到位于马里兰州的病毒载体卓越中心(CoE)。。

Charles River’s viral vector tech transfer program offers phase-appropriate and customizable frameworks to yield exceptional stability, helping to avoid costly and time-consuming program delays. The Fast Track framework enables a streamlined approach to tech transfer when no process changes are required.

Charles River的病毒载体技术转移计划提供了适合阶段的可定制框架,以产生非凡的稳定性,有助于避免昂贵且耗时的计划延迟。快速通道框架可以在不需要更改流程的情况下简化技术转让方法。

The Modular framework facilitates fully customizable tech transfer for more complex scenarios when processes are not yet fully developed or process changes are required, such as switching a cell line, plasmid supply, and/or assay/analytical development, bolstered by Charles River’s premier testing platform.

模块化框架有助于在查尔斯河卓越测试平台的支持下,在流程尚未完全开发或需要流程更改(例如切换细胞系,质粒供应和/或分析/分析开发)的情况下,为更复杂的场景提供完全可定制的技术转移。

Both frameworks enable reliable transfer to the viral vector CoE, avoiding preventable delays and safeguarding continued program success..

这两个框架都能够可靠地转移到病毒载体CoE,避免可预防的延迟并保障项目的持续成功。。

With full-scale, in-house plasmid DNA and viral vector production capabilities, Charles River can efficiently manage tech transfers for a wide range of viral vectors, such as adeno-associated virus (AAV), adenovirus, lentivirus, and retrovirus. Once technology transfer has been initiated, developers gain access to Charles River’s integrated concept to cure portfolio, spanning discovery through safety assessment and commercialization..

凭借全面的内部质粒DNA和病毒载体生产能力,Charles River可以有效地管理各种病毒载体的技术转移,例如腺相关病毒(AAV),腺病毒,慢病毒和逆转录病毒。一旦启动技术转让,开发人员就可以使用Charles River的综合概念来治愈投资组合,从发现到安全评估和商业化。。

Explore Flexible Tech Transfer at the BIO International Convention

在国际生物技术大会上探索灵活的技术转让

Charles River will showcase its viral vector tech transfer framework at the BIO International Convention, June 3-6, 2024 in San Diego, CA. The Charles River team will be exhibiting at booth #4827, and you can submit insights for the live visual map here.

Charles River将于2024年6月3日至6日在加利福尼亚州圣地亚哥举行的生物国际大会上展示其病毒载体技术转移框架。Charles River团队将在4827号展位展出,您可以在这里提交实时视觉地图的见解。

During the conference, Ramin Baghirzade, PhD, Senior Director, Global Head Commercial, Gene Therapy CDMO Services, will take to the BioProcess International Theater stage on June 4 at 2:00 p.m. to present, Seamless Viral Vector Tech Transfer at Any Phase: Offering Stability in Times of Change.

会议期间,基因治疗CDMO服务全球商业总监高级总监Ramin Baghirzade博士将于6月4日下午2:00进入BioProcess International Theater舞台,在任何阶段展示无缝病毒载体技术转移:在变化时期提供稳定性。

Viral Vector Manufacturing Services

病毒载体制造服务

Charles River’s viral vector center of excellence offers viral vector tech transfer and manufacturing to support any stage of the drug development lifecycle, from research-grade viral vector manufacturing for in vitro and in vivo studies to commercial-scale GMP manufacturing. In recent years, the Company has significantly broadened its cell and gene therapy portfolio with several acquisitions and expansions to simplify complex supply chains and meet the growing demand for plasmid DNA, viral vector, and cell therapy services..

Charles River的病毒载体卓越中心提供病毒载体技术转让和制造,以支持药物开发生命周期的任何阶段,从用于体外和体内研究的研究级病毒载体制造到商业规模的GMP制造。近年来,该公司通过几次收购和扩张显着扩大了其细胞和基因治疗组合,以简化复杂的供应链,并满足对质粒DNA,病毒载体和细胞治疗服务日益增长的需求。。

Watch the latest expert roundtable, Streamlining Cell and Gene Therapy Scalability: Progress Towards a Gold Standard, on-demand, and gain insights from a development, manufacturing, and testing perspective: https://bit.ly/3UCX8LW

观看最新的专家圆桌会议,简化细胞和基因治疗的可扩展性:朝着金标准、按需的方向发展,并从开发、制造和测试的角度获得见解:https://bit.ly/3UCX8LW

Approved Quotes

批准的报价

“A reliable, end-to-end CDMO is critical for continuity of supply and program efficiency. Charles River’s viral vector technology transfer program provides gene therapy developers with a cohesive concept-to-cure solution portfolio, fine tuned over decades supporting advanced therapy clients from discovery to commercialization and every step in between.” – Kerstin Dolph, Corporate Senior Vice President, Global Manufacturing, Charles River.

“可靠的端到端CDMO对于供应的连续性和项目效率至关重要。Charles River的病毒载体技术转移项目为基因治疗开发人员提供了一个连贯的概念来治愈解决方案组合,经过数十年的微调,支持从发现到商业化以及其间的每一步的高级治疗客户。”——Charles River全球制造公司高级副总裁Kerstin Dolph。

“Viral vector manufacturing and tech transfer is complex, requiring precision and accuracy to avoid costly and time-consuming program delays. Meticulously built to provide a seamless tech transfer at any phase, the viral vector tech transfer program provides stability in times of change.” – Ramin Baghirzade, PhD, Senior Director, Global Head Commercial, Gene Therapy CDMO Services, Charles River.

“病毒载体制造和技术转移是复杂的,需要精确和准确,以避免昂贵和耗时的程序延迟。病毒载体技术转移程序经过精心构建,可在任何阶段提供无缝的技术转移,在变化时提供稳定性。”——查尔斯河基因治疗CDMO服务全球商业总监Ramin Baghirzade博士。

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.

查尔斯河提供重要的产品和服务,以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其研究和药物开发工作。我们敬业的员工专注于为客户提供他们所需要的,以改进和加速为需要的患者发现、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服务范围的信息,请访问www.criver.com。。

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