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2022年02月09日,云舟生物科技(广州)股份有限公司,简称“云舟生物”,与颇尔公司(Pall Corporation),简称“颇尔”,在云舟生物中国广州总部举行战略合作签约仪式,正式达成战略合作关系。
云舟生物将与颇尔共同挂牌成立“云舟—颇尓基因递送体系合作中心”,通过整合双方的优势技术与先进设备资源,为云舟生物的CDMO工艺优化平台实现高效能、可持续发展赋能。
目前,云舟生物GMP标准化车间安装颇尔iCELLis Nano 、iCELLis 500+等设备作为哺乳动物细胞贴壁培养的生物反应器,服务于小试工艺开发以及大规模临床生产,最终满足细胞治疗、基因治疗以及疫苗开发等领域的规模化的市场需求。
现场照片(左滑查看更多)
“为满足基因治疗市场爆发式的GMP相关产品需求,云舟生物立足自身平台和技术优势,建设了10,000平方米的GMP标准化车间,全面展开基于基因治疗临床药物的全方位CDMO业务。”云舟生物首席技术官叶知晟博士表示,“这标志着云舟生物正式从科研市场进军基因治疗临床领域,充满机遇的同时也充满挑战。因此,对于此次和颇尔的深入合作我们十分期待。我们期望通过高效、自动化的GMP生产流程的创建与优化,以及多平台的共同搭建,让云舟生物成为未来世界基因治疗领域的领袖。”
颇尔基因治疗业务部总经理Clive Glover博士表示:“我们非常高兴能够与云舟生物共同携手,为高速增长的基因治疗市场提供高效的GMP级别基因递送解决方案。颇尔的设备组合为云舟生物的CDMO服务提供了独特的多功能上游、下游以及流体处理解决方案,协助云舟生物开发新一代高效工业规模的病毒载体制备工艺。希望通过双方的合作,共同推荐基因治疗产业的蓬勃发展。”
● 合作方背景 ●
云舟生物科技(广州)股份有限公司是基因工程领域的全球领跑者,旨在为基础科研到临床应用提供基因递送的全链条式解决方案。云舟生物提供的全链条基因递送服务包括:科研级别以及临床级别的载体定制、病毒包装、文库构建筛选、稳定细胞株构建、mRNA制备、蛋白生产、建立非人灵长类动物在内的多种动物模型用以载体优化(如衣壳进化)和载体组织分布鉴定、以及CDMO服务等,可满足客户对于慢病毒(Lentivirus)、 腺病毒(Adenovirus)、腺相关病毒(AAV)、HSV病毒、VSV病毒、mRNA体外转录合成等多种载体递送方式的需求,应用范围覆盖整个生命科学和生物医药领域。
云舟生物自进军基因治疗市场以来,投入使用GMP设施约10,000平方米,CDMO项目已经遍布北美、欧洲、日本等多个国家和地区。该业务包含基因药物研发管线全阶段的技术服务,涵盖临床前研究、临床试验和商业化生产等阶段的GMP级别载体设计、质粒制备、病毒生产、细胞库建立、工艺开发和质量控制。
颇尔公司(Pall Corporation),简称“颇尔”,为丹纳赫集团(纽约证券交易所代码:DHR)生命科学平台旗下运营公司。颇尔进入中国已有二十多年,为过滤、分离和纯化提供全套解决方案。从上游研发到规模生产,从售前技术支持到售后服务,从产品销售到提供整体解决方案,颇尔不仅提供给客户高科技的产品和应用,更扮演着权威技术及创新品质的先锋角色。
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February 9th, 2022, VectorBuilder Inc. and Pall Corporation held a signing ceremony in VectorBuilder’s GMP manufacturing facility in Guangzhou, China, to officially launch a strategic partnership.
VectorBuilder and Pall Corporation will jointly set up the “VectorBuilder-Pall Center for Gene Delivery Technologies”. By integrating superior technological knowhow and advanced instrumentation of the two parties, the Center aims to build a technology platform for continuous CDMO process optimization. Situated within VectorBuilder’s GMP facilities, the Center features Pall’s small-scale iCELLis™ Nano bioreactor and clinical-scale iCELLis 500+ bioreactors along with other equipment. The focus of the Center is to optimize adherent-cell-based GMP manufacturing of viral vectors to meet market demands from cell therapy, gene therapy and vaccine applications.
“In order to meet the explosive demand for GMP products in the gene delivery space, VectorBuilder has built 100,000 square feet of GMP facilities, and launched a comprehensive CDMO business portfolio for the production of gene therapy drugs and vector-based vaccines”, says Dr. Jason Ye, Vice President of Biomanufacturing of VectorBuilder. “This marks VectorBuilder’s rapid expansion from the research market into the clinical market. It is full of growth opportunities but also has many technical challenges. We therefore very much look forward to this in-depth partnership with Pall. We hope that through the creation of optimized, efficient and automated GMP manufacturing platforms, VectorBuilder will further establish its global leadership in custom viral vector manufacturing.”
“We are very pleased to support VectorBuilder as the demand for GMP gene delivery solutions continues to grow” said Dr. Clive Glover, General Manager of Pall Corporation’s gene therapy business. “Pall’s broad portfolio uniquely supports these processes with versatile upstream, downstream and fluid handling solutions and we are happy to share our knowledge to help VectorBuilder develop a new generation of efficient, industrial-scale viral vector manufacturing processes”.
VectorBuilder is a rapidly growing biotechnology company specializing in advanced genetic engineering solutions for research and medicine. In particular, VectorBuilder has established itself as the global leader in gene delivery that covers a range of products and services, including vector design and optimization, vector cloning, virus packaging, library construction and screening, stable cell line generation, vector optimization (e.g. capsid evolution) and vector biodistribution analysis using animal models including nonhuman primates (NHPs), and GMP manufacturing of clinical-grade plasmids, mRNAs, proteins, viruses and cell lines. One highlight of VectorBuilder's innovative solutions is its revolutionary online platform for designing and ordering custom vectors, available at https://www.vectorbuilder.com. This award-winning platform has become highly popular with researchers around the world and has grown into an industry standard for its rich functionalities, extensive experimental validations, and easy-to-use graphical interface. By leveraging the popularity of this platform, VectorBuilder has built a comprehensive portfolio of offerings covering virtually all gene delivery needs from bench to bedside.
Pall Corporation is a filtration, separation and purification leader providing solutions to meet the critical fluid management needs of customers across the broad spectrum of life sciences and industry. Pall works with customers to advance health, safety and environmentally responsible technologies. The Company’s engineered products enable process and product innovation and minimize emissions and waste. Pall Corporation serves customers worldwide. For more information visit www.pall.com.
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