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Model Predictive Feeding Rate Control in Conventional and Single-use Lab-scale Bioreactors: A Study on Practical Application

机译：常规和一次性实验室规模生物反应器中的模型预测进料速率控制：实际应用研究

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A developed solution for fed-batch process modeling and model predictive control (MPC), facilitating good manufacturing practice (GMP) based on process elaboration, control, and validation, is presented in the paper. The step-by-step evolution of the so-called “golden batch” optimal biomass growth profile and its control during the process is demonstrated. The case study of an advanced fed-batch control was performed on the recombinant E. coli BL21 lab-scale (5.4 L) biomass production process using the conventional stirred tank glass reactor. Additionally, a test experiment for control reproducibility and applicability assessment of the proposed approach was carried out in a single-use stirred tank reactor (5.7 L). Four sequentially performed experiments are demonstrated as an example for desirable feeding profile evolution for E. coli BL21 biomass production in a glucose-limited fed-batch process. Under different initial biomass and glucose conditions, as well as for different reference feeding profiles selected in the explorative experiments, good tracking quality of preset reference trajectories by the MPC system has been demonstrated. Estimated and experimentally measured biomass mean deviations from the preset reference value at the end of the processes were 4.6 and 3.8 %, respectively. Biomass concentration of 93.6 g L–1 (at 24 h) was reached in the most productive run. Better process controllability and safer process run, in terms of avoiding culture overfeeding but still maintaining a sufficiently high growth rate, was suggested for the process with biomass yield of 79.8 g L–1 (at 24 h). Practical recommendations on the approach application and adaptation for fed-batch cultures of interest are provided.
机译：本文提出了一种用于批生产过程建模和模型预测控制（MPC）的开发解决方案，该解决方案基于过程的详细说明，控制和验证促进了良好的生产规范（GMP）。演示了所谓的“黄金批次”最佳生物量生长曲线的逐步演变及其在过程中的控制。使用常规搅拌釜玻璃反应器在重组大肠杆菌BL21实验室规模（5.4 L）生物质生产过程中进行了先进的分批进料控制的案例研究。此外，在一次性搅拌釜反应器（5.7升）中进行了针对该方法的控制重现性和适用性评估的测试实验。以四个连续执行的实验为例，证明了在葡萄糖受限的补料分批进料过程中，大肠杆菌BL21生物量生产所需的补料曲线演变。在不同的初始生物量和葡萄糖条件下，以及在探索性实验中选择的不同参考进料模式下，已经证明了MPC系统对预设参考轨迹的良好跟踪质量。在过程结束时，估计的和实验测量的生物量平均偏离预设参考值分别为4.6％和3.8％。在最高产的运行中，生物量浓度达到93.6 g L-1（在24 h时）。对于生物量产量为79.8 g L–1（在24 h时）的过程，建议在避免培养物超喂但仍保持足够高的生长速度方面更好的过程可控性和更安全的过程运行。提供了有关目标补料分批培养的方法应用和适应性的实用建议。

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