Pall iCELLis貼壁細(xì)胞生物反應(yīng)器
——大規(guī)模病毒生產(chǎn)，工藝轉(zhuǎn)換簡單，500m²培養(yǎng)面積


美國Pall頗爾公司生產(chǎn)的iCELLis系列固定床生物反應(yīng)器（iCELLis Fixed-Bed Bioreactors），專為基因治療、細(xì)胞治療領(lǐng)域設(shè)計(jì)，是一種全集成、自動(dòng)化、高細(xì)胞密度的一次性生物反應(yīng)器，用于貼壁細(xì)胞、慢病毒LV、腺病毒AV、腺相關(guān)病毒AAV大規(guī)模生產(chǎn)，包括用于可行性研究和實(shí)驗(yàn)室規(guī)模生產(chǎn)的iCELLis Nano系統(tǒng)（4m²培養(yǎng)表面積），和工業(yè)規(guī)模生產(chǎn)的iCELLis 500系統(tǒng)（500m²培養(yǎng)表面積）。
 


 
iCELLis生物反應(yīng)器，使用緊湊型固定床并填充定制微載體，材料采用醫(yī)藥級(jí)滌綸超細(xì)纖維，可提供高達(dá)500m²的培養(yǎng)表面積，相當(dāng)于3,000只細(xì)胞培養(yǎng)轉(zhuǎn)瓶（每只1700cm²）。其培養(yǎng)條件，非常類似傳統(tǒng)2D培養(yǎng)，如細(xì)胞工廠等，因此可以從傳統(tǒng)培養(yǎng)器具直接轉(zhuǎn)換，而無需重新進(jìn)行大量條件優(yōu)化，快速推進(jìn)研究進(jìn)程，縮短條件摸索的時(shí)間。
 


 
iCELLis可在很低的細(xì)胞密度下接種，僅需20個(gè)滾瓶即可接種一個(gè)iCELLis 500反應(yīng)器。全集成一次性培養(yǎng)耗材，顯著減少人工操作。采用磁力葉輪攪拌，瀑布式供氧，使培養(yǎng)基循環(huán)分布均勻，低剪切力，細(xì)胞高活力。高度自動(dòng)化系統(tǒng)，提高批間一致性，令病毒滴度高而一致，高重現(xiàn)性。 



 
預(yù)先安裝校準(zhǔn)探頭，實(shí)時(shí)監(jiān)控培養(yǎng)pH、溶氧、二氧化碳含量。配套SCADA操作系統(tǒng)，符合GAMP和FDA 21 CRF Part 11要求，可追溯。

 



 

iCELLis生物反應(yīng)器優(yōu)勢
①與傳統(tǒng)2D平板培養(yǎng)條件非常相似，無需額外優(yōu)化，培養(yǎng)放大性能可預(yù)測
②細(xì)胞培養(yǎng)過程簡化，從培養(yǎng)瓶到最終產(chǎn)品快速生產(chǎn)
③實(shí)時(shí)監(jiān)控，可追溯
④全集成，一次性，高重復(fù)性，高一致性

 


 
從iCELLis Nano到iCELLis 500線性放大，無需調(diào)整工藝。

 

參考文獻(xiàn)

1. Factors affecting kLa in Pall's iCELLis bioreactor. A.Laskowski, S.Gupta, T.Lundeen, et al. Cytotherapy, 2020, Volume 22, Issue 5, Page S150

2. Development and optimization of large scale production of adenoviral vector and autologous insulin producing cell using iCELLis 500 and Xpansion 200 single-use bioreactors. R.Legmann, A.Reniers, N.Kohlstrom, et al. Cytotherapy, 2017, Volume 19, Issue 5, Page S117-S118

3. Intensified Production of Vaccinia-Based Oncolytics in the High Density Cell Respirator (HDCR) Bioreactor Improves Vaccine Logistics and Economics. Cook, Colin, Kang, et al. Molecular Therapy, 2021, page 397-398

4. Platform for the growth and propogation of HEK293 cells and adenovirus viral vector amplification. T.Sanderson, T.Joseph, T.Haq, et al.Cytotherapy, 2019, Volume 21, Issue 5, Pages S24-S25

5. Adherent HEK293T cells cultured in Pall's iCELLis nano bioreactor with OptiPEAK HEK293T blood-free chemically defined media exhibit robust and rapid population doubling times and lentivirus expression. R.Alfano, A.Pennybaker, A.Laskowski, T.Lundeen. Cytotherapy, 2020, Volume 22, Issue 5, Page S151

6. Oncolytic virus scalability affinity chromatography process. A.Thakur, H.Mallory, K.Chung, et al.Cytotherapy, 2020, Volume 22, Issue 5, Page S137

7. Platform approach for the AAV purification process including membrane chromatography for polishing. K.Boenning, J.Huato, A.Hejmowski, et al. Cytotherapy, 2020, Volume 22, Issue 5, Page S186

8. Maintaining excellence in a high volume academic cell therapy production facility through optimization of space utilization, operations, scheduling and staffing. A.Lamontagne, T.A.Colligon, C.Taylor, et al. Cytotherapy, 2020, Volume 22, Issue 5, Pages S149-S150

9. A rapid and reliable qPCR based system to quantitate HEK 293 residual DNA for GMP lot release in gene therapy manufacturing. L.Yan, M.Mateling, K.Norman. Cytotherapy, 2020, Volume 22, Issue 5, Page S186

10. Automated imaging and analysis of colony founding stem and progenitor cells—correlation of early quality attributes with future biological performance.V.R. Mantripragada, V. Luangphakdy, E. Kwee, et al. Cytotherapy, 2017, Volume 19, Issue 5, page S119


更多iCELLis生物反應(yīng)器信息，歡迎點(diǎn)擊右側(cè)在線咨詢
——Pall一級(jí)代理商，北京澤平