
商务合作

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BioCina Pty Ltd., a global end-to-end biologics Contract Development and Manufacturing Organisation (CDMO), and NovaCina Pty Ltd., a global fill-and-finish CDMO, announced a strategic partnership to provide integrated drug substance and drug product solutions for biologics developers.
全球端到端生物制剂合同开发和制造组织(CDMO)的BioCina Pty Ltd.和全球填充和完成CDMO的NovaCina Pty Ltd.宣布建立战略合作伙伴关系,为生物制剂开发商提供综合药物和药物产品解决方案。
This alliance enables BioCina to offer the highest quality fill-and-finish solutions to their clients, to convert the drug substance produced at its state-of-the-art Adelaide, South Australia facility into ready-to-use drug product at NovaCina's advanced facility in Perth, Australia. This collaboration marks a significant milestone in providing end-to-end biopharmaceutical manufacturing solutions to clients worldwide..
该联盟使BioCina能够为其客户提供最高质量的填充和精加工解决方案,将其最先进的南澳大利亚阿德莱德工厂生产的原料药转化为NovaCina位于澳大利亚珀斯的先进工厂的即用药品。这一合作标志着为全球客户提供端到端生物制药制造解决方案的一个重要里程碑。
'Our partnership promises unparalleled quality with adherence to the highest regulatory standards to set new benchmarks.'
“我们的合作关系承诺了无与伦比的质量,并坚持最高的监管标准,以设定新的基准。”
BioCina delivers highest quality, cost-effective CDMO services, including cell line development, process development, and cGMP drug substance manufacturing for the microbial, pDNA and mRNA modalities.
BioCina提供最高质量,具有成本效益的CDMO服务,包括微生物,pDNA和mRNA模式的细胞系开发,工艺开发和cGMP药物制造。
As a result of this partnership, BioCina's clients can benefit from NovaCina's decades of clinical and commercial fill-and-finish experience, backed by numerous regulatory approvals, including from the U.S. Food and Drug Administration (FDA). NovaCina offers a comprehensive suite of services, including development, manufacturing, packaging, labeling, and stability studies..
由于这种合作关系,BioCina的客户可以受益于NovaCina数十年的临床和商业填充和完成经验,并得到包括美国食品和药物管理局(FDA)在内的众多监管批准。NovaCina提供全面的服务,包括开发、制造、包装、标签和稳定性研究。
BioCina's Chief Executive Officer & member of NovaCina Board of Directors, Mark W. Womack said, 'BioCina is excited to partner with NovaCina, integrating our globally recognized expertise in clinical and commercial process development and drug substance manufacturing with their esteemed drug product services.
BioCina首席执行官兼NovaCina董事会成员马克·沃马克(Mark W.Womack)表示,“BioCina很高兴与NovaCina合作,将我们在临床和商业流程开发以及药物制造方面的全球公认专业知识与他们备受推崇的药物产品服务相结合。
This partnership promises to deliver unparalleled quality, adherence to the highest regulatory standards, and on-time delivery of client programs, setting a new benchmark in the market.'NovaCina's Chief Executive Officer, Cyrus K. Mirsaidi stated, 'We are very excited to form this partnership with BioCina.
这种合作关系承诺提供无与伦比的质量,遵守最高的监管标准,按时交付客户计划,在市场上树立新的基准。”NovaCina首席执行官塞勒斯·K·米尔赛迪(CyrusK.Mirsaidi)表示,“我们非常高兴能与BioCina建立这种合作关系。
Together, we provide a seamless end-to-end offering. At NovaCina, we are delighted to bring our world-class quality and safety to this value-adding collaboration.'About BioCinaBioCina is a global end-to-end biologics Contract Development and Manufacturing Organisation (CDMO) of choice, offering high-quality, cost-effective cell line development, process development and cGMP clinical & commercial manufacturing for the microbial, pDNA and mRNA modalities.
我们共同提供无缝的端到端服务。在NovaCina,我们很高兴为这一增值合作带来世界一流的质量和安全。”关于BioCinaBioCina是一家全球端到端生物制剂合同开发和制造组织(CDMO)的首选,为微生物,pDNA和mRNA模式提供高质量,经济高效的细胞系开发,工艺开发以及cGMP临床和商业制造。
Our US FDA, EMA and TGA approved site in South Australia, which was previously a Pfizer facility, is staffed with a tremendously experienced technical and operations team, with most critical SME's having an average tenure of 15+ years at the Adelaide site. To address the ever-evolving requirements of our current and future clients, we are adding a 2000 L microbial fermenter and large-scale mRNA manufacturing in our Adelaide facility, and we will be establishing a second facility with Mammalian PD and large-scale manufacturing.
我们在澳大利亚南部的美国FDA、EMA和TGA批准的工厂以前是辉瑞的工厂,拥有经验丰富的技术和运营团队,最关键的中小企业在阿德莱德工厂的平均任期为15年以上。为了满足当前和未来客户不断变化的需求,我们正在阿德莱德工厂增加一个2000升微生物发酵罐和大规模mRNA制造,我们将建立第二个哺乳动物PD和大规模制造工厂。