Lim Mayasari, Ye Hua, Panoskaltsis Nicki, Drakakis Emmanuel M, Yue Xicai, Cass Anthony E G, Radomska Anna, Mantalaris Athanasios
Biological Systems Engineering Laboratory, Department of Chemical Engineering, Imperial College London, SW7 2AZ, United Kingdom.
Biotechnol Adv. 2007 Jul-Aug;25(4):353-68. doi: 10.1016/j.biotechadv.2007.02.002. Epub 2007 Feb 15.
The need for successful ex-vivo expansion and directed differentiation of haematopoietic stem cells (HSCs) for therapeutic applications has increased over the past decade. Haematopoietic cell cultures are complex and full characterisation of the process environment has yet to be achieved. The complexity and transient nature of HSC cultures make the identification, maintenance and control of optimal operating conditions challenging. Application of real-time, on-line monitoring techniques and process control strategies enhances the ability to operate bioprocesses of desired reproducibility and high product quality. In this review, we discussed the methods by which in vitro culture information necessary for bioprocess control may be obtained, including process considerations, monitoring and analytical tools, and design of experiments (DOE). The successful application of these tools may result in time- and cost-effective cultures for directed differentiation and expansion of haematopoietic components intended for clinical use.
在过去十年中，为了治疗应用而对造血干细胞（HSCs）进行成功的体外扩增和定向分化的需求不断增加。造血细胞培养很复杂，对过程环境的全面表征尚未实现。HSC培养的复杂性和短暂性使得识别、维持和控制最佳操作条件具有挑战性。应用实时在线监测技术和过程控制策略可提高操作具有所需重现性和高产品质量的生物过程的能力。在本综述中，我们讨论了获取生物过程控制所需的体外培养信息的方法，包括过程考量、监测和分析工具以及实验设计（DOE）。这些工具的成功应用可能会带来用于临床的造血成分定向分化和扩增的省时且经济高效的培养方法。
