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The LOVO Cell Processing system

自動化細胞處理收集系統

LOVO

LOVO自動化細胞處理收集系統,可以在符合GTP規範下,全程無菌的進行血小板去除,或細胞經擴增後的清洗、收集濃縮包裝、及DMSO Washing去除。

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說明

LOVO是腫瘤免疫治療製造生產的好設備儀器

 

LOVO自動化細胞處理收集系統

LOVO是利用專利設計的Spinning membrane 技術,membrane設計了4um pores,以Size Filtration的方式,自動的執行血袋樣本中血小板的去除、Sample Washing、Volume reduction、Beads labeling & incubation、Medium exchange及Product formulation 等工作。獨特的 Filtration 設計,有別於傳統離心原理,LOVO沒有離心G力產生的細胞應激反應,因此細胞存活率很高。利用 Size filtration的原理,對於要去除培養液中特定成分、或是凍存後去除抗凍液(DMSO)的效果非常好,細胞回收率也較傳統離心原理的方式高.

 

LOVO適合異體細胞治療公司

 

LOVO用於自體細胞治療前處理

臨床上細胞經過清洗濃縮處理血液分離產物(Leukapheresis product)可利用LOVO清洗去除血小板,再以CliniMACS CD34+ 磁珠標記分選,進一步利用LOVO進行多餘磁珠的清洗及體積調整,就可使用CliniMACS Plus分選儀進行標的細胞分選,取得高純度標的細胞。根據論文研究顯示,經上述純化步驟,其白血球回收率(WBC recovery rate)及血小板去除率(PLT depletion rate)可分別達到 91.9 ± 2.2% 和99.8 ± 0.0%, 進一步分析,標的細胞回收率(CD34+ cell recovery)也高達90 %以上,其存活率(CD34+ cell viability)可保持99%,足以證明LOVO在清洗過程參予提升高純度標的細胞取得。。

LOVO可以用在活細胞治療上

LOVO 自動化處理,不只減少時間、人力,更能符合GMP規範

自動化的處理能力,相較於手動離心清洗步驟,也讓處理時間從4-5小時大福縮短至2小時,大幅縮短了細胞製備的時間及提升人員操作的效率。LOVO 在製程使用上,是透過管柱銜接袋子或反應槽(Tank)達到密閉無菌連結,其管路與循環都是封閉係式系統,讓細胞生產全程更加安全化、標準化及自動化,減少人為操作的交叉污染及品質變異(Quality variation issue),提供無菌、安全及高效率的細胞處理流程,若搭配CliniMACS Plus一起使用,從細胞清洗、分離、純化與細胞培養,形成完整的自動化製程,以符合GMP規範。

 

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Description

Lovo
Automated Cell Processing System

PROCESS FAST. MAXIMIZE CONTROL.

Only Lovo delivers automated, functionally closed cell processing through spinning membrane filtration.
 

Revolutionary Automation

Maximize reliability,and efficiency.

Reduce the possibility of operator error while maximizing operational efficiency. Lovo adapts to your custom protocols.

 

Spinning Membrane

Product consistency and quality you expect.

Capture the cells you need, optimizing recovery while maintaining viability. The membrane’s 4 μm pores enable high TNC recovery, cell viability, and supernatant removal.

 

Auto Dilution

Continuous processing.
No membrane fouling.

Simplify processing of highly concentrated source products. Lovo automatically dilutes the cell suspension as it enters the spinning membrane module.

 

 

The LOVO Cell Processing system is for laboratory use only. Unless the user has obtained advance clearance or approval from the appropriate regulatory agency, cells processed on this system are not intended for diagnostic purposes, direct transfusion, or for use in the production of therapeutic products or vaccines for clinical use. For applications requiring regulatory clearance or approval, users may request the required LOVO technical documentation from Fresenius Kabi to support their submissions.

Refer to the LOVO Cell Processing System Operator’s Manual for a complete list of warnings and precautions associated with the use of this device.

References

  1. LOVO 2.X Blood Run Protocol Report: 223-DER-048957 – Data on file at Fresenius Kabi USA.
  2. LOVO 2.X Product Quality Test Results Design Review: 223-DER-048958 – Data on file at Fresenius Kabi USA.
  3. Lovo New Membrane Cultured Cell Testing Results: 223-DER-066723 – Data on file at Fresenius Kabi USA.
  4. B.Mfarrej, et al. Pre-clinical assessment of the Lovo device for dimethyl sulfoxide removal and cell concentration in thawed hematopoietic progenitor cell grafts. Cytotherapy, Volume 19, Issue 12, 1501-1508.
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