Sepax 2

Fully-automated and compact solution to process blood, blood derivatives, and cellular products.

Description

Description

The Sepax 2 S-100 is a mobile, closed capability system that efficiently processes umbilical cord blood, bone marrow, peripheral blood or other blood derivatives, as permitted by applicable regulatory requirements. The fundamental scientific technology relies on a separation chamber that provides both separation through rotation of the syringe chamber (centrifugation) and component transfer through displacement of the syringe piston. An optical sensor measures the light absorbency of the separated components and manages the flow direction of each of them in the correct output container.

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Specifications

Specifications

Code

S-100、C-PRO

Power

Input range
Input frequency
Consumption

Dimensions

40 x 27 x 46(h) cm

Net Weight

16.3 Kg

Centrifuge

Max speed: 8000 rpm
Speed range: 1700 - 8000 rpm
Over speeds protection: 8800 rpm

Environmental conditions

Temperature: 7ºC – 27ºC
Relative humidity: 30% – 75%

Software

Software

UCB-HES
使用羥乙基澱粉(Hydroxyethyl Starch, HES)作為沈降劑濃縮臍帶血的有核細胞部分。
來源產品:臍帶血
初始容量:35 – 320 mL
最終容量:20 – 50 mL
作業時間:~35分鐘
建議耗材:CS-530.1, CS-530.4, CS-530.4b, CS-540.4, CS-540.4b, CS-570.4, CS-570.4mb
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UCB
不使用沈降劑濃縮臍帶血的有核細胞部分。
來源產品:臍帶血
初始容量:35 – 290 mL
最終容量:10 – 50 mL
作業時間:~30分鐘
建議耗材:CS-530.1, CS-530.4, CS-530.4b, CS-540.4, CS-540.4b, CS-570.4, CS-570.4mb
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PlasmaFree
僅去除臍帶血(UCB)的血漿同時保留富含造血幹細胞的有核細胞(Buffy Coat)以及紅血球的方案。該方案不需要添加任何沉降劑。
來源產品:臍帶血
初始容量:35 – 440 mL
最終容量:依據初始容量判斷
作業時間:~25分鐘
建議耗材:CS-430.1, CS-470.0
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PeriCell
去除白血球分離術血品內的血漿。
來源產品:白血球分離術血品
初始容量:100 – 840 mL
最終容量:30 – 600 mL
作業時間:~20分鐘
建議耗材:CS-430.1, CS-490.1
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NeatCell
透過梯度密度溶液(如Ficoll)將粒細胞及紅血球(RBC)去除以分離出單核球細胞(MNC)。
來源產品:骨髓、臍帶血、白血球分離術血品
初始容量:30 – 120 mL
最終容量:8 – 20 mL或45 mL
作業時間:~75分鐘
建議耗材:CS-900.2
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SmartRedux
濃縮各式血品(特別是骨髓)的有核細胞部分。
來源產品:骨髓、臍帶血、全血
初始容量:30 – 3300 mL
最終容量:1 – 1500 mL
作業時間:~20分鐘
建議耗材:CS-490.1
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ReadyCell
濃縮骨髓的有核細胞部分。
來源產品:骨髓
初始容量:30 – 220 mL
最終容量:7 – 20 mL
作業時間:~15分鐘
建議耗材:CS-470.1
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CordWash
洗滌去除解凍後臍帶血的細胞碎片、抗凍劑、游離血紅素。
來源產品:解凍後臍帶血
初始容量:10 – 100 mL
最終容量:50 – 150 mL
作業時間:~30分鐘
建議耗材:CS-600.1
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SmartWash
洗滌去除解凍後白血球分離血品的細胞碎片、抗凍劑、游離血紅素。
來源產品:解凍後白血球分離血品
初始容量:50 – 880 mL
最終容量:50 – 200 mL
作業時間:~40分鐘
建議耗材:CS-600.1
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CultureWash
洗滌去除培養擴增後的細胞產品的細胞碎片、抗凍劑、游離血紅素,並減容或置換培養液。
來源產品:培養擴增後的細胞產品
初始容量:30 – 880 mL
最終容量:8 – 200 mL
作業時間:~40分鐘
建議耗材:CS-600.1, CS-900.2
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Dilution
稀釋細胞製品並分裝成多袋(最多5袋)
來源產品:細胞製品
初始容量:0 – 220 mL
最終容量:最多5袋
作業時間:~10分鐘
建議耗材:CS-490.1, CS-600.1, CS-900.2
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Adipose
分離酵素分解後脂肪(Digested Lipoaspirate)內的有核細胞。
來源產品:基質血管部份(stromal-vascular fraction, SVF)
初始容量:0 – 220 mL
最終容量:最多5袋
作業時間:~10分鐘
建議耗材:CS-900.2
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PlateletFree
洗滌去除白血球分離術血品內的血小板
來源產品:白血球分離術血品
初始容量:50 – 880 mL
最終容量:50 – 200 mL
作業時間:~10分鐘
建議耗材:CS-600.1
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BeadWash(C-Pro Only)
依序執行濃縮、去血小板、磁珠結合、洗滌多餘磁珠
來源產品:白血球分離術血品
初始容量:20 – 880 mL
最終容量:8 – 500 mL
作業時間:~80分鐘
建議耗材:CT-60.1(同CS-600.1)
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Video

Video

References

References

1.Singh H, Figliola MJ, Dawson MJ, et al. Manufacture of clinical-grade CD19-specific T cells stably expressing chimeric antigen receptor using Sleeping Beauty system and artificial antigen presenting cells. PLoS One. 2013;8(5):e64138. Published 2013 May 31. doi:10.1371/journal.pone.0064138
文章闡述一種使用睡美人系統(Sleeping Beauty system)製備醫療級CAR-T細胞的方法。文章中的研究方法(Materials and Methods)提及Sepax被運用在製程的PBMC Isolation及aAPC(artificial Antigen Presenting Cells) Harvest兩程序…
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2.Hanley PJ, Mei Z, da Graca Cabreira-Hansen M, et al. Manufacturing mesenchymal stromal cells for phase I clinical trials. Cytotherapy. 2013;15(4):416–422. doi:10.1016/j.jcyt.2012.09.007
文章闡述一種製備醫療級間質幹細胞(Mesenchymal Stem Cell, MSC)的方法。文章中的研究方法(Methods)提及Sepax被運用在BM MNC Isolation程序…
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3.Safinia, Niloufar & Grageda, Nathali & Scottà, Cristiano & Thirkell, Sarah & J. Fry, Laura & Vaikunthanathan, Trishan & I. Lechler, Robert & Lombardi, Giovanna. (2018). Cell Therapy in Organ Transplantation: Our Experience on the Clinical Translation of Regulatory T Cells. Frontiers in Immunology. 9. 10.3389/fimmu.2018.00354.
文章闡述調節型T細胞(Regulatory T Cell, Treg)在器官移植上的臨床轉化經驗。文章中所設計之Treg的體外擴增GMP製程中提及Sepax被運用在其PBMC Isolation程序…
#NeatCell #SmartRedux
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4.jungebluth, philipp & Holzgraefe, Bernhard & Ling Lim, Mei & Duru, Adil & Lundin, Vanessa & Heldring, Nina & Wiklander, Oscar & Z Nordin, Joel & Chrobok, Michael & Roderburg, Christoph & Sjoqvist, Sebastian & Anderstam, Björn & Beltran Rodriguez, Antonio & Haag, Johannes & Gustafsson, Ylva & G Roddewig, Katharina & Jones, Petra & J.A. Wood, Matthew & Luedde, Tom & Macchiarini, Paolo. (2015). Autologous Peripheral Blood Mononuclear Cells as Treatment in Refractory Acute Respiratory Distress Syndrome. Respiration. 90. 10.1159/000441799.
文章闡述利用自體PBMC作為急性呼吸窘迫症候群(Acute respiratory distress syndrome, ARDS)的治療方式的病例報告。文章中的研究方法(Materials and Methods)提及Sepax被運用在PBMC Isolation程序…
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5.Laura Medina Marrero, José García-Arroba Peinado, Carme Talarn Forcadell, Laia Ramiro Infante, Virginia Callao Molina, Carmen Azqueta Molluna, Nuria Martínez Llonch, Elena Valdivia García, Margarita Codinach Creus, Margarita Blanco García, Susana García Gómez, Luciano Rodríguez Gómez, Lourdes Escoda Teigell, Sergi Querol Giner.  Successful management of severe adverse effects during autologous peripheral blood stem cell infusion and policy implementation regarding washing products. The 44th Annual Meeting of the European Society for Blood and Marrow Transplation: Physicians Poster Sessions. 2018; 95–96
文章闡述兩起非霍奇金氏淋巴瘤(non-Hodgkin’s lymphoma )患者進行自體幹細胞移植時引發嚴重不良反應後採取移植品洗滌措施的案例報告。文章中提及Sepax被運用在低溫保存細胞製品的回溫後洗滌程序…
#SmartWash
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6.Lily Lu, Tangying & Pugach, Omar & Somerville, Robert & A Rosenberg, Steven & N Kochenderfer, James & Better, Marc & Feldman, Steven. (2016). A Rapid Cell Expansion Process for Production of Engineered Autologous CAR-T Cell Therapies. Human Gene Therapy Methods. 27. 10.1089/hgtb.2016.120.
文章闡述一種僅需六日的CD19 CAR-T細胞製程。文章中提及Sepax被運用在Ficoll Isolation、細胞活化後洗滌、成品洗滌程序…
#PeriCell #NeatCell #CultureWash
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7.Jelena L. Holovati, Brenda Letcher, Kelly Murphy, Sheila Langevin, Mike Halpenny, Tanya Petraszko, Heidi Elmoazzen. (2019). Effectiveness monitoring outcomes: one year post-implementation of an automated closed volume reduction system in processing of hematopoietic progenitor cells for autologous transplant. 2019 Cell Therapy Transplant Canada Conference. 2019;40
文章闡述加拿大血液中心在實行自體造血幹細胞減量程序以降低DMSO含量的一年後成效。文章中提及Sepax被運用其減量程序…
#PeriCell
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8.GE Healthcare Life Sciences. (2019). Workflow for primary human NK cell isolation, xeno-free expansion, harvest, and cryopreservation
文章闡述一種從新鮮白血球分離術血品(Fresh leukapheresis)製備出NK細胞並符合GMP準則的製程。文章中提及Sepax被運用其NK Cell Isolation程序…
#BeadWash
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9.Dazey B., et al. Cord blood processing by using a standard manual technique and automated closed system “Sepax” (Kit CS-530). Stem Cells Dev. 14, 6–10 (2005).
文章比較手動方式以及Sepax進行臍帶血減量程序…
#UCB-HES
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9.Aktas, M.G., Buchheiser, A., Houben, A.P., Reimann, V., Radke, T.F., Jeltsch, K.S., Maier, P., Zeller, W.J., & Kogler, G. (2010). Good manufacturing practice-grade production of unrestricted somatic stem cell from fresh cord blood. Cytotherapy, 12 3, 338-48 .
文章闡述一種從臍帶血中製備幹細胞並符合GMP準則的方法。文章中的研究方法(Methods)提及Sepax被運用在製程中的MNC Isolation程序…
#NeatCell
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Related Information

Related Information

1.細胞療法巨擎—諾華、凱德、朱諾都靠它!!
從專利資料發現朱諾、凱德及諾華的製程無獨有偶都導入同樣的設備……..
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2.幹細胞減量: Less is More
幹細胞凍存前一般會先執行減量,用意是去除血品中的紅血球及血漿,保留富含幹細胞的Buffy Coat……..
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3.智慧減量軟體: SmartRedux
SmartRedux是Sepax的減量軟體,主要功能是全自動、封閉式地將血品分離成Bufft Coat、血漿、紅血球並分裝至不同血袋以利後續使用 ……..
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