2021-01-14 16:34:54來源:藥方舟瀏覽量:1408
戰(zhàn)略伙伴關(guān)系展示了Charles River作為全球合作伙伴的承諾
威爾明頓,馬薩諸塞州和上海,2021年1月14日消息—查爾斯河實(shí)驗(yàn)室(NYSE: CRL)今天宣布,已與生物制藥行業(yè)端到端質(zhì)量管理服務(wù)商——駕玉生物(JADE Biomedical)達(dá)成戰(zhàn)略合作伙伴關(guān)系。該合作伙伴關(guān)系將擴(kuò)大Charles River的生物制品檢測能力,并有助于滿足其對于生物制藥產(chǎn)品(尤其是細(xì)胞和基因療法)的需求,從而重申了公司作為全球發(fā)展合作伙伴的承諾。這一戰(zhàn)略關(guān)系也將促使駕玉生物目前位于上海的國際CGMP標(biāo)準(zhǔn)生物大分子產(chǎn)品檢測業(yè)務(wù)加速擴(kuò)展到中國的第二個(gè)實(shí)驗(yàn)室,并進(jìn)一步擴(kuò)展駕玉完整的生物制藥質(zhì)量技術(shù)承包和檢測業(yè)務(wù)。
隨著全球生物制藥行業(yè)的快速發(fā)展,對可靠的專業(yè)合同服務(wù)商的需求也在不斷增長。細(xì)胞和基因治療市場的商業(yè)化發(fā)展需要用科學(xué)和專業(yè)的質(zhì)量管理知識來駕馭全球復(fù)雜的監(jiān)管環(huán)境。駕玉生物憑借其對全球趨勢和當(dāng)?shù)丨h(huán)境的深刻理解,以及其旨在為支持全球各種規(guī)模的客戶(從本地初創(chuàng)企業(yè)到全球大公司)提供的商業(yè)運(yùn)營模式,成為Charles River全球生物制品服務(wù)鏈中及其重要的一員;同時(shí),將于今年夏天上線的第二個(gè)檢測實(shí)驗(yàn)室,也將進(jìn)一步提高駕玉生物基于客戶不斷增長的需求而提高其CGMP和GLP檢測能力及規(guī)模。
關(guān)于雙方的合作
“全球范圍內(nèi)對于細(xì)胞和基因療法研發(fā)工作的高要求,促使企業(yè)必須尋求那些既了解市場的復(fù)雜性,又能夠自如的駕馭當(dāng)?shù)匚⒚畋O(jiān)管環(huán)境的全球合作伙伴。通過與駕玉生物的合作,我們將能夠更加深入的將我們的專業(yè)知識和當(dāng)?shù)氐目茖W(xué)監(jiān)管網(wǎng)絡(luò)相結(jié)合,為客戶提供本地化的知識,從而將兩個(gè)組織定位為激烈的競爭市場中,為客戶提供服務(wù)的首選合作伙伴 ”- Birgit Girshick, Charles River公司執(zhí)行副總裁,負(fù)責(zé)生物制劑測試解決方案和禽流感疫苗服務(wù)的研發(fā)和安全評估工作。
“駕玉生物成立的宗旨是服務(wù)于中國乃至國際市場對于生物制藥行業(yè)不斷增長的需求。駕玉生物的簽約生物制劑質(zhì)量組織—Bio-CQO? 提供了端到端的質(zhì)量和監(jiān)管技術(shù)服務(wù),這是對生物制品外包服務(wù)行業(yè)的重要補(bǔ)充,同時(shí)也填補(bǔ)了質(zhì)量和合規(guī)方面缺乏專業(yè)知識和領(lǐng)導(dǎo)能力方面的空白。我們非常感謝近年來中國有利的監(jiān)管環(huán)境以及全球領(lǐng)先的生物制藥公司的信任,這些信任使我們能夠形成獨(dú)樹一幟的服務(wù)模式和品牌形象。為了延續(xù)我們在生物療法領(lǐng)域,尤其是在基因和細(xì)胞療法領(lǐng)域中的發(fā)展,我們需要一個(gè)具有全球影響力的合作伙伴。而Charles River將依托其行業(yè)領(lǐng)先的服務(wù)策略和法規(guī)專業(yè)知識,幫助我們?yōu)楸镜啬酥寥蛟絹碓蕉嗟钠髽I(yè)提供更好地服務(wù)和支持” —Claudia Lin博士,駕玉生物創(chuàng)始人兼首席執(zhí)行官。
關(guān)于Charles River
Charles River為全球的制藥和生物技術(shù)公司提供必需的產(chǎn)品和服務(wù),以加快其藥物研究和開發(fā)工作。我們敬業(yè)的員工致力于以客戶的切身需求為出發(fā)點(diǎn)而提供服務(wù),從而促進(jìn)和改善新療法的發(fā)現(xiàn)、早期研發(fā)和安全生產(chǎn)工作,并最終服務(wù)于患者。欲了解我們獨(dú)特的產(chǎn)品組合和廣泛的服務(wù),請?jiān)L問www.criver.com
Charles River投資者聯(lián)系人:
Todd Spencer781-222-6455
公司投資者關(guān)系部副總裁
todd.spencer@crl.com
Charles River媒體聯(lián)系人:
Amy Cianciaruso781-222-6168
公司公共關(guān)系副總裁
amy.cianciaruso@crl.com
關(guān)于駕玉生物
駕玉生物為全球的生物制藥公司提供專業(yè)的質(zhì)量、法規(guī)和分析檢測服務(wù)。作為世界上首家登記注冊的生物制藥合同質(zhì)量組織Bio-CQO?,駕玉生物的服務(wù)模塊包括質(zhì)量保證,產(chǎn)品質(zhì)量管理,藥品注冊申報(bào),QC方法驗(yàn)證和檢測、CMC和分析方法開發(fā)指導(dǎo)、廠房設(shè)施設(shè)計(jì)和驗(yàn)證、冷鏈管理等。駕玉生物的創(chuàng)始人和領(lǐng)導(dǎo)團(tuán)隊(duì)均為在大分子藥物開發(fā)及生產(chǎn)質(zhì)量管理方面與NMPA、FDA、 EMA、PMDA和PICS合作有著豐富經(jīng)驗(yàn)的行業(yè)精英。我們依靠不斷壯大的專業(yè)團(tuán)隊(duì),通過為客戶提供靈活而可靠的定制化質(zhì)量和CMC系統(tǒng)并領(lǐng)導(dǎo)具體實(shí)施來支持客戶從IND前到上市后的產(chǎn)業(yè)化過程。 駕玉生物的合同檢測服務(wù)可提供適用于全球先進(jìn)CGMP標(biāo)準(zhǔn)兼容的實(shí)驗(yàn)室分析檢測服務(wù),支持國際化產(chǎn)品申報(bào)需求。我們的專業(yè)知識涵蓋包括單克隆抗體,抗體歐聯(lián)物,細(xì)胞和基因治療等各種產(chǎn)品類型。欲深入了解駕玉生物及當(dāng)前的招聘職位,請?jiān)L問http://jade.bio/
駕玉生物投資聯(lián)系人:
Claudia Lin 林巧
CEO
claudialin@jadebiomedical.com
駕玉生物媒體聯(lián)系人:
James Vang
市場拓展總監(jiān)
jamesvang@jadebiomedical.com
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 a strategic 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 local start-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
About Charles River
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. 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
About 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