GBI Biomanufacturing Expands Capabilities With Automated Aseptic Fill-Finish for Drug Products
GBI Biomanufacturing Expands Capabilities With Automated Aseptic Fill-Finish for Drug Products
PLANTATION, Fla., Nov. 20, 2024 /PRNewswire/ -- GBI Biomanufacturing (GBI), one of the world's longest serving contract development and manufacturing organizations (CDMO), is pleased to announce the expansion of its Drug Product (DP) services, to include automated sterile fill and finish capabilities. GBI has the ability to support clients from clinical trials to commercial launch, for both Drug Substance (DS) and DP, all at its one location in Florida, USA. This addition demonstrates GBI's commitment to delivering advanced and flexible Single-Source Solutions for the rapidly evolving pharmaceutical and biotech industries.
美国佛罗里达州普兰特田(Plantation)-2024年11月20日/美通社(PRNewswire)- 全球连续服务时间最长的合同开发和制造组织(CDMO)之一GBT生物制造(GBI)高兴地宣布扩大其药物产品(DP)服务,包括自动无菌灌装和成品能力。GBT拥有能力支持客户从临床试验到商业推出,无论是药品物质(DS)还是DP,全部都在其位于美国佛罗里达州的一个地点。此举展示了GBT致力于为不断发展的制药和生物技术行业提供先进灵活的单一来源解决方案的承诺。
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The ability to provide an in-house, dual approach of automated and manual sterile fill finish, enables GBI to meet the diverse needs of its clients with precision and efficiency. For smaller, early-stage clinical batches or products requiring special handling, manual aseptic vial filling offers flexibility and control. Automated aseptic liquid filling employing ready-to-use components supports higher-throughput production with minimal human intervention, reducing the risk of contamination and increasing batch consistency, making it ideal for both clinical and commercial-scale projects.
提供内部双重方法的自动和手动灌注成品能力,使GBT能够精确高效地满足客户的多样化需求。对于较小的早期临床批次或需要特殊处理的产品,手动无菌小瓶灌装提供了灵活性和控制。采用即用型元件进行自动无菌液体灌装支持高通量生产,人机介入最小化,降低了污染风险,增加了批次一致性,这对临床和商业规模项目均非常理想。
"Adding automated aseptic fill-finish capabilities to our service offerings strengthens our ability to meet the diverse requirements of our clients, from start-up biotech to established pharmaceutical companies," said Karl Pinto, & CEO at GBI. "Our facility is equipped with state-of-the-art technology and a team of experts, capable of delivering high-quality, regulatory compliant drug products."
"增加自动无菌灌装成品能力扩展了我们的服务范围,增强了我们满足客户多样化需求的能力,从初创生物技术公司到成熟的制药公司,"GBT首席执行官Karl Pinto表示。"我们的设施配备了先进技术和一支专家团队,能够提供高质量、符合监管要求的药品产品。"
GBI's new three format automated filler has capabilities to support filling in vials, syringes and cartridges, across various drug classes such as biologics, vaccines, bioconjugates and complex large molecules.
GBT的新型三格式自动灌装机具有支持小瓶、注射器和卡式备份的能力,可在各种药物类别中进行灌装,如生物制品、疫苗、生物偶联物和复杂大分子。
The addition of these capabilities aligns with GBI's broader mission to provide its clients with end-to-end development and cGMP manufacturing services as a Single-Source Solution CDMO. The company's enhanced fill-finish capacity will simplify its clients' manufacturing supply chains and help in achieving faster timelines, improved scalability, regulatory compliance and the convenience of having both DS and DP material manufactured at one site!
这些能力的新增与GBT更广泛的使命相一致,为客户提供端到端的开发和cGMP制造服务作为单一来源解决方案CDMO。公司增强的灌装成品能力将简化客户的制造供应链,并有助于实现更快的时间表、改进的可伸缩性、符合监管要求以及在同一地点制造DS和DP材料的便利性!
About GBI
关于GBI
GBI is a leading CDMO focused on providing comprehensive, high-quality services to the global pharmaceutical and biotech sectors. With expertise in process development, analytical services, DS manufacturing and sterile fill finish for biologics, GBI supports the development and commercialization of life-saving therapies worldwide.
GBI是一家领先的CDMO公司,专注为全球药品和生物技术行业提供全面、高质量的服务。GBI 在工艺开发、分析服务、生物制品DS制造和灭菌填充工艺方面拥有专业知识,支持全球生命拯救疗法的开发和商业化。
For more information on GBI, a drug substance and sterile fill finish CDMO visit: or contact via .
有关GBI的更多信息,药品物质和灭菌填充工艺CDMO,请访问: 或通过 联系。
Media Contact: [email protected]
媒体联系人:[email protected]
SOURCE GBI Biomanufacturing
资源来源 GBI 生物制造