摇瓶（RAMOS 和 SFR）在线监测法开发 293HEK 细胞规模化生物工艺
HEK293 Cell-Based Bioprocess Development at Bench Scale by Means of Online Monitoring in Shake Flasks (RAMOS and SFR).
机构信息
Adolf Kühner AG, Birsfelden, Switzerland.
Kuhner Shaker Inc., San Carlos, CA, USA.
出版信息
Methods Mol Biol. 2020;2095:83-103. doi: 10.1007/978-1-0716-0191-4_6.
The platforms for bioprocess development have been developed in parallel to the needs of the manufacturing industry of biopharmaceuticals, aiming to ensure the quality and safety of their products. In this sense, Quality by Design (QbD) and Process Analytical Technology (PAT) have become the pillars for quality control and quality assurance.A new combination of Shake Flask Reader (SFR) and Respiration Activity Monitoring System for online determination of OTR and CTR (RAMOS) allows online monitoring of main culture parameters needed for bioprocess development (pH, pO, OTR, CTR, and QR) as presented below. Eventually, a case study of the application of the combination of SFR-RAMOS system is presented. The case study discloses the optimization of HEK293 cells cultures through the manipulation of their metabolic behavior.
生物工艺开发平台是为了满足生物制药制造业的需求而开发的，旨在确保产品的质量和安全性。在这方面，质量源于设计（QbD）和过程分析技术（PAT）已经成为质量控制和质量保证的支柱。Shake Flask Reader（SFR）和在线测定 OTR 和 CTR 的呼吸活性监测系统（RAMOS）的新组合允许在线监测生物工艺开发所需的主要培养参数（pH、pO、OTR、CTR 和 QR），如下所示。最终，介绍了 SFR-RAMOS 系统组合应用的案例研究。该案例研究通过操纵 HEK293 细胞的代谢行为来优化其培养。
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