密閉式、無菌之細胞分選系統

CliniMACS ^® Plus 細胞分選儀為臨床等級系統，可用於目標細胞的富集分選，或是剃除掉不需要的細胞群。其無菌密閉式的管路設計可避免傳統開放式操作的汙染，使用上將患者檢體在經過前處理並與臨床級磁珠抗體混合後，連接到無菌管路即可啟動分選程序，該系統會自動進行一系列分選步驟，最後分選出需要的目標細胞。自動化的過程讓細胞分選過程更加容易及穩定。

(CliniMACS Plus, Prodigy, Cell therapy, microbeads, Close system, Cell sorting, CART, NK cell, DC)

自動化細胞分選，可進行不同細胞之enrichment或depletion

Miltenyi Biotec的MACS^® 磁性細胞分選技術發展已久，此技術主要是利用高專一性的單株抗體結合，經由可生物降解的50 nm磁珠來標記目標細胞，再透過專利的管柱形成的梯度磁場中進行目標細胞的分選富集，由於此系統的奈米磁珠的生物安全性高，因此臨床應用上無需去除磁珠，依據該技術所發展的臨床級產品，目前已廣泛使用於特定疾病適應症的治療，並取得FDA與TFDA認證，於臨床研究部分，由於已取得醫療上的先例，對於研究者較容易與轉譯醫學無縫接軌，因此MACS細胞分選系統亦已廣泛應用在免疫、腫瘤、神經研究等各領域。

(Magnetic separation, Enrichment cell, target cell, column, clinical, MACS)

自動化控制分選流速，不同種類細胞可進行不同流速之分選，確保管路內細胞分選品質

CliniMACS Plus 針對不同種細胞內建完整的應用程式，有測試好的條件搭配相對應的Tubing set，提供標準化細胞分選流程，

(CART, Cell therapy, B cell, T cell, TCRα/β, gamma/delta T, monocyte)

臨床等級、安全無慮

CliniMACS^®系統，包含磁株抗體、Tubing、CliniMACS Plus、以及PBS/EDTA 皆通過ISO 13485認證，並為CE-marked 之醫療器材；同時CliniMACS CD34 Reagent, CliniMACS Tubing Set TS & LS, 以及CliniMACS PBS/EDTA Buffer皆通過美國FDA認證

英文說明

Principle of magnetic cell separation

The CliniMACS® Plus Instrument utilizes a reagent consisting of an antibody that specifically binds to a specific surface marker on the target cell. The antibody is conjugated to an iron-containing particle that is only nanometers in size and biocompatible.

The enrichment of target cells or depletion of unwanted cells is accomplished by passing the antibody/magnetically-labeled cell suspension through a magnetic separation column, which is provided as part of a single-use disposable tubing set. Labeled cells are retained within the separation column, while unlabeled cells flow through. Recovery of enriched cells is achieved by removing the magnetic field and eluting the targeted cells into a collection bag.

Tubing Sets for CliniMACS Plus Instrument

Single-use Tubing Sets for the CliniMACS Plus Instrument are sealed, pre-assembled tubing packs for magnetic cell separation. The individual CliniMACS Separation strategy determines which CliniMACS Tubing Set should be selected.

Applications

The CliniMACS Plus Instrument enables clinical-scale separations for a variety of cells, including hematopoietic stem cells, mesenchymal stem cells, monocytes, DCs, NK cells, B cells, and T cell subsets, for use in the fields of regenerative medicine, adoptive immunotherapy, and graft engineering.