Pall iCELLis貼壁細胞生物反應器
——大規模病毒生產，工藝轉換簡單，500m²培養面積


美國Pall頗爾公司生產的iCELLis系列固定床生物反應器（iCELLis Fixed-Bed Bioreactors），專為基因治療、細胞治療領域設計，是一種全集成、自動化、高細胞密度的一次性生物反應器，用于貼壁細胞、慢病毒LV、腺病毒AV、腺相關病毒AAV大規模生產，包括用于可行性研究和實驗室規模生產的iCELLis Nano系統（4m²培養表面積），和工業規模生產的iCELLis 500系統（500m²培養表面積）。
 


 
iCELLis生物反應器，使用緊湊型固定床并填充定制微載體，材料采用醫藥級滌綸超細纖維，可提供高達500m²的培養表面積，相當于3,000只細胞培養轉瓶（每只1700cm²）。其培養條件，非常類似傳統2D培養，如細胞工廠等，因此可以從傳統培養器具直接轉換，而無需重新進行大量條件優化，快速推進研究進程，縮短條件摸索的時間。
 


 
iCELLis可在很低的細胞密度下接種，僅需20個滾瓶即可接種一個iCELLis 500反應器。全集成一次性培養耗材，顯著減少人工操作。采用磁力葉輪攪拌，瀑布式供氧，使培養基循環分布均勻，低剪切力，細胞高活力。高度自動化系統，提高批間一致性，令病毒滴度高而一致，高重現性。 



 
預先安裝校準探頭，實時監控培養pH、溶氧、二氧化碳含量。配套SCADA操作系統，符合GAMP和FDA 21 CRF Part 11要求，可追溯。

 



 

iCELLis生物反應器優勢
①與傳統2D平板培養條件非常相似，無需額外優化，培養放大性能可預測
②細胞培養過程簡化，從培養瓶到最終產品快速生產
③實時監控，可追溯
④全集成，一次性，高重復性，高一致性

 


 
從iCELLis Nano到iCELLis 500線性放大，無需調整工藝。

 

參考文獻

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


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——Pall一級代理商，北京澤平