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GBI Biomanufacturing Expands Capabilities With Automated Aseptic Fill-Finish for Drug Products

GBI Biomanufacturing Expands Capabilities With Automated Aseptic Fill-Finish for Drug Products

GBI生物製造通過自動化無菌灌裝-封裝技術擴展藥品產品的能力
PR Newswire ·  11/21 01:00

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.

美國佛羅里達州普蘭特田(Plantation)-2024年11月20日/美通社(PRNewswire)- 全球連續服務時間最長的合同開發和製造組織(CDMO)之一GBT生物製造(GBI)高興地宣佈擴大其藥物產品(DP)服務,包括自動無菌灌裝和成品能力。GBT擁有能力支持客戶從臨床試驗到商業推出,無論是藥品物質(DS)還是DP,全部都在其位於美國佛羅里達州的一個地點。此舉展示了GBT致力於爲不斷髮展的製藥和生物技術行業提供先進靈活的單一來源解決方案的承諾。

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GBI Biomanufacturing logo (PRNewsfoto/GBI Biomanufacturing)
GBT生物製造標誌(PRNewsfoto/GBT生物製造)

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.

提供內部雙重方法的自動和手動灌注成品能力,使GBT能夠精確高效地滿足客戶的多樣化需求。對於較小的早期臨床批次或需要特殊處理的產品,手動無菌小瓶灌裝提供了靈活性和控制。採用即用型元件進行自動無菌液體灌裝支持高通量生產,人機介入最小化,降低了污染風險,增加了批次一致性,這對臨床和商業規模項目均非常理想。

"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."

"增加自動無菌灌裝成品能力擴展了我們的服務範圍,增強了我們滿足客戶多樣化需求的能力,從初創生物技術公司到成熟的製藥公司,"GBT首席執行官Karl Pinto表示。"我們的設施配備了先進技術和一支專家團隊,能夠提供高質量、符合監管要求的藥品產品。"

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的新型三格式自動灌裝機具有支持小瓶、注射器和卡式備份的能力,可在各種藥物類別中進行灌裝,如生物製品、疫苗、生物偶聯物和複雜大分子。

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!

這些能力的新增與GBT更廣泛的使命相一致,爲客戶提供端到端的開發和cGMP製造服務作爲單一來源解決方案CDMO。公司增強的灌裝成品能力將簡化客戶的製造供應鏈,並有助於實現更快的時間表、改進的可伸縮性、符合監管要求以及在同一地點製造DS和DP材料的便利性!

About GBI

關於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是一家領先的CDMO公司,專注爲全球藥品和生物技術行業提供全面、高質量的服務。GBI 在工藝開發、分析服務、生物製品DS製造和滅菌填充工藝方面擁有專業知識,支持全球生命拯救療法的開發和商業化。

For more information on GBI, a drug substance and sterile fill finish CDMO visit: or contact via .

有關GBI的更多信息,藥品物質和滅菌填充工藝CDMO,請訪問: 或通過 聯繫。

Media Contact: [email protected]

媒體聯繫人:[email protected]

SOURCE GBI Biomanufacturing

資源來源 GBI 生物製造

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