查尔斯河实验室与驾玉生物合作,扩大生物制药服务的能力

查尔斯河实验室与驾玉生物合作,扩大生物制药服务的能力

威尔明顿,马萨诸塞州和上海,2021114日消息查尔斯河实验室(NYSE:CRL)今天宣布,已与生物制药行业端到端质量管理服务商——驾玉生物(JADE Biomedical)达成战略合作伙伴关系。该合作伙伴关系将扩大Charles River的生物制品检测能力,并有助于满足其对于生物制药产品(尤其是细胞和基因疗法)的需求,从而重申了公司作为全球发展合作伙伴的承诺。这一战略关系也将促使驾玉生物目前位于上海的国际CGMP标准生物大分子产品检测业务加速扩展到中国的第二个实验室,并进一步扩展驾玉完整的生物制药质量技术承包和检测业务。

 
查尔斯河实验室与驾玉生物合作,扩大生物制药服务的能力
 

随着全球生物制药行业的快速发展,对可靠的专业合同服务商的需求也在不断增长。细胞和基因治疗市场的商业化发展需要用科学和专业的质量管理知识来驾驭全球复杂的监管环境。驾玉生物凭借其对全球趋势和当地环境的深刻理解,以及其旨在为支持全球各种规模的客户(从本地初创企业到全球大公司)提供的商业运营模式,成为Charles River全球生物制品服务链中及其重要的一员;同时,将于今年夏天上线的第二个检测实验室,也将进一步提高驾玉生物基于客户不断增长的需求而提高其CGMPGLP检测能力及规模。

 
查尔斯河实验室与驾玉生物合作,扩大生物制药服务的能力

关于双方的合作

全球范围内对于细胞和基因疗法研发工作的高要求,促使企业必须寻求那些既了解市场的复杂性,又能够自如的驾驭当地微妙监管环境的全球合作伙伴。通过与驾玉生物的合作,我们将能够更加深入的将我们的专业知识和当地的科学监管网络相结合,为客户提供本地化的知识,从而将两个组织定位为激烈的竞争市场中,为客户提供服务的首选合作伙伴。

Birgit Girshick, Charles River公司执行副总裁,负责生物制剂测试解决方案和禽流感疫苗服务的研发和安全评估工作。

 

驾玉生物成立的宗旨是服务于中国乃至国际市场对于生物制药行业不断增长的需求。驾玉生物的签约生物制剂质量组织—Bio-CQO®提供了端到端的质量和监管技术服务,这是对生物制品外包服务行业的重要补充,同时也填补了质量和合规方面缺乏专业知识和领导能力方面的空白。我们非常感谢近年来中国有利的监管环境以及全球领先的生物制药公司的信任,这些信任使我们能够形成独树一帜的服务模式和品牌形象。为了延续我们在生物疗法领域,尤其是在基因和细胞疗法领域中的发展,我们需要一个具有全球影响力的合作伙伴。而Charles River将依托其行业领先的服务策略和法规专业知识,帮助我们为本地乃至全球越来越多的企业提供更好地服务和支持。

— Claudia Lin博士,驾玉生物创始人兼首席执行官

关于Charles River

查尔斯河实验室与驾玉生物合作,扩大生物制药服务的能力

Charles River为全球的制药和生物技术公司提供必需的产品和服务,以加快其药物研究和开发工作。我们敬业的员工致力于以客户的切身需求为出发点而提供服务,从而促进和改善新疗法的发现、早期研发和安全生产工作,并最终服务于患者。欲了解我们独特的产品组合和广泛的服务,请访问www.criver.com

联系方式

Charles River投资者联系人  Todd Spencer  

公司投资者关系部副总裁 781-222-6455

todd.spencer@crl.com

Charles River媒体联系人  Amy Cianciaruso

公司公共关系副总裁 781-222-6168

amy.cianciaruso@crl.com

关于驾玉生物

查尔斯河实验室与驾玉生物合作,扩大生物制药服务的能力

驾玉生物为全球的生物制药公司提供专业的质量、法规和分析检测服务。作为世界上首家登记注册的生物制药合同质量组织Bio-CQOR,驾玉生物的服务模块包括质量保证,产品质量管理,药品注册申报,QC方法验证和检测、CMC和分析方法开发指导、厂房设施设计和验证、冷链管理等。驾玉生物的创始人和领导团队均为在大分子药物开发及生产质量管理方面与NMPA、FDA、 EMA、PMDA和PICS合作有着丰富经验的行业精英。我们依靠不断壮大的专业团队,通过为客户提供灵活而可靠的定制化质量和CMC系统并领导具体实施来支持客户从IND前到上市后的产业化过程。驾玉生物的合同检测服务可提供适用于全球先进CGMP标准兼容的实验室分析检测服务,支持国际化产品申报需求。我们的专业知识涵盖包括单克隆抗体,抗体欧联物,细胞和基因治疗等各种产品类型。欲深入了解驾玉生物及当前的招聘职位,请访问http://www.jade.bio/ 

联系方式

驾玉生物投资联系人  Claudia Lin  林巧 CEO

claudialin@jadebiomedical.com

驾玉生物媒体联系人  James Vang 市场拓展总监

jamesvang@jadebiomedical.com

 

Charles River Partners with JADE Biomedical

to Expand Biologics Capabilities

Strategic partnership demonstrates Charles River’s commitment as a global partner

WILMINGTON, MA and SHANGHAI, January 14, 2021 – Charles River Laboratories International, Inc. (NYSE: CRL) announced today that it has entered into astrategic partnership with JADE Biomedical, a provider of end-to-end quality management services for the biopharmaceutical industry. The partnership will expand Charles River’s biologics testing capabilities geographically and help to accommodate demand for biologics therapeutics, especially cell and gene therapies, reaffirming the company’s commitment as a global development partner. This strategic relationship will also enable JADE Biomedical to expand their current global cGMP product testing operations in Shanghai into a second facility in China and further build upon its current offering of comprehensive biologics quality management and testing services.

 

As the biologics therapeutics industry across the globe continues to grow at a rapid pace, so does the demand for a reliable, contract services partner. The recent growth in commercialization effort in the cell and gene therapy market requires both scientific and regulatory expertise to navigate the complex, global regulatory environment. JADE Biomedical’s deep understanding of the global trend and local environment, and its infrastructure designed to support clients of all sizes – from localstart-ups to global organizations, makes it a highly valuable addition to Charles River’s network. The addition of a second testing facility, which will come online later this year, will provide additional capacity to better support clients’ growing needs. The new facility will offer Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) services to clients.

 

Approved Quotes

Around the world, R&D efforts for cell and gene therapies are in high demand. Companies are seeking global partners who understand the complexities of this market, while also knowing how to navigate the nuanced regulatory environment in their region. Working with JADE Biomedical, we will be able to combine our expertise to provide localized knowledge with a deep scientific and regulatory network, positioning both organizations as go-to partners for clients in this competitive market.

 – Birgit Girshick, Corporate Executive Vice President, Discovery and Safety Assessment, Biologics Testing Solutions, and Avian Vaccine Services, Charles River

JADE Biomedical was founded with the purpose of serving the growing needs of the biopharmaceutical industry, not only in China, but internationally. JADE Biomedical’s contracted Biologics Quality Organization, Bio-CQO®,where end-to-end quality and regulatory technical services are provided is an important addition to the biologics outsourced services industry, filling gaps in shortage of expertise and leadership in quality and compliance. We are extremely grateful to the conducive regulatory environment in recent years in China, and the trust of leading, global biopharmaceutical companies that have allowed us to form a unique service model and brand. To continue our growth in biologics therapeutics, especially in the gene and cell therapy space, we needed a partner with global reach. With an industry-leading portfolio of services and regulatory expertise, Charles River will help us support an increasing number of clients globally and locally.

– Claudia Lin, PhD, Founder and CEO, Jade Biomedical

 

Approved Charles River

Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutionsaround 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. To learn more about our unique portfolio and breadth of services, visit http://criver.com/.

Investor Contact for Charles River:

Todd Spencer

Corporate Vice President, Investor Relations

781-222-6455

todd.spencer@crl.com

Media Contact for Charles River:

Amy Cianciaruso

Corporate Vice President, Public Relations

781-222-6168

amy.cianciaruso@crl.com

 

Approved Jade Biomedical (JADE)

Jade Biomedical provides expert Quality, Regulatory and Analytical Testing Services to the Biopharmaceutical companies worldwide. It is the world’s first registered Biologics Contract Quality Organization, Bio-CQO®. JADE service portfolio includes Quality Assurance, Regulatory Submission, QC Method Validation and Testing, general CMC and Analytical Development, Facility Design and Qualification, Cold Chain Management, etc. JADE founder and leaders have extensive drug regulatory experience with agencies including NMPA, FDA, EMA, PMDA and PICS. Our growing team of experts provide custom-made flexible yet robust Quality and CMC systems and lead their implementation in support of clients’ clinical and commercial programs from pre-IND to post launch. Jade Biomedical contract testing services offer a complete range of analytical testing services suitable for global regulatory filings in our state of the art, global cGMP compliant labs. Our expertise covers all therapeutics platforms including monoclonal antibodies, antibody-drug-conjugates, cell and gene therapies. To learn more about JADE and for current open positions, visit http://jade.bio/.

 

Investor Contact for JADE Biomedical:

Claudia Lin

Founder & CEO

 

Media Contact for JADE Biomedical:

James Vang

Business Development Director

jamesvang@jadebiomedical.com

 

查尔斯河实验室与驾玉生物合作,扩大生物制药服务的能力
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查尔斯河实验室与驾玉生物合作,扩大生物制药服务的能力

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