品牌故事
SmartBuffers® 擁有6000平方米、符合GMP百級、萬級與十萬級標準的潔淨生產廠房, 專注於化妝品及生物原輔料、重組活性蛋白、體外診斷試劑及細胞治療相關工具產品的設計、研發與製造。擁有多項國際發明專利和無細胞高表達蛋白發酵技術, 我們在人源重組蛋白和生物相容緩衝液等細分領域中處於行業領先地位, 產品銷售全球120多個國家, 並為多達30家國際知名品牌的優良供應商。通過持續優化的自動化規模化生產和技術創新, SmartBuffers®持續為客戶提供高效、穩定且標準化的整體解決方案, 引領生物製劑新標準。
SmartBuffers® offers a one-stop solution for custom liquid raw materials in biopharmaceutical processes, including essential bioprocess buffers, culture media, purified water, and IVD reagents, with wide applications in vaccines, cell- and protein-based therapies, research and diagnostics reagents. Leveraging deep expertise in time-to-market and regulatory compliance, we can scale production from research-grade to clinical-grade (GMP) within weeks, guaranteeing outstanding performance, full traceability, batch-to-batch consistency, and a robust, reliable supply chain to help you launch new products quickly and safely.
核心產品
High Purity Water for Injection (WFI)
SmartBuffers® WFI 無菌注射水兼具最高等級的無菌與低內毒素標準，同時達到細胞培養級水質需求與工業化量產彈性。我們的產品經過多重過濾及完整品管驗證，不僅超越 USP 與 Ph. Eur.（歐洲藥典）規範，並同時滿足研發至商業化生產各階段的使用需求。
1.Reliable
manufactured in an ISO 13485 and cGMP-certified facility to ensure lot-to-lot consistency.
2.USP & Ph. Eur. Exceedance
Validated to surpass official water-for-injection monographs, ensuring compliance and regulatory confidence.
3.Non-Pyrogenic & Sterile
Multi-stage filtration and continuous integrity monitoring guarantee< 0.25 EU/mL endotoxin and certified sterility.
4.Flexible Packaging & Supply
Available in volumes from 5 mL ampule or 500 mL bottle to custom sizes to suit your needs.
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