de Vos Paul, Bucko Marek, Gemeiner Peter, Navrátil Marián, Svitel Juraj, Faas Marijke, Strand Berit Løkensgard, Skjak-Braek Gudmund, Morch Yrr A, Vikartovská Alica, Lacík Igor, Kolláriková Gabriela, Orive Gorka, Poncelet Dennis, Pedraz Jose Luis, Ansorge-Schumacher Marion B
University Hospital Groningen, Section of Medical Biology, Transplantation Biology and Immunoendocrinology, Hanzeplein 1, 9700RB Groningen, The Netherlands.
Biomaterials. 2009 May;30(13):2559-70. doi: 10.1016/j.biomaterials.2009.01.014. Epub 2009 Feb 7.
Bioencapsulation involves the envelopment of tissues or biological active substances in semipermeable membranes. Bioencapsulation has been shown to be efficacious in mimicking the cell's natural environment and thereby improves the efficiency of production of different metabolites and therapeutic agents. The field of application is broad. It is being applied in bioindustry and biomedicine. It is clinically applied for the treatment of a wide variety of endocrine diseases. During the past decades many procedures to fabricate capsules have been described. Unfortunately, most of these procedures lack an adequate documentation of the characterization of the biocapsules. As a result many procedures show an extreme lab-to-lab variation and many results cannot be adequately reproduced. The characterization of capsules can no longer be neglected, especially since new clinical trials with bioencapsulated therapeutic cells have been initiated and the industrial application of bioencapsulation is growing. In the present review we discuss novel Approached to produce and characterize biocapsules in view of clinical and industrial application. A dominant factor in bioencapsulation is selection and characterization of suitable polymers. We present the adequacy of using high-resolution NMR for characterizing polymers. These polymers are applied for producing semipermeable membranes. We present the pitfalls of the currently applied methods and provide recommendations for standardization to avoid lab-to-lab variations. Also, we compare and present methodologies to produce biocompatible biocapsules for specific fields of applications and we demonstrate how physico-chemical technologies such as FT-IR, XPS, and TOF-SIMS contribute to reproducibility and standardization of the bioencapsulation process. During recent years it has become more and more clear that bioencapsulation requires a multidisciplinary approach in which biomedical, physical, and chemical technologies are combined. For adequate reproducibility and for understanding variations in outcome of biocapsules it is advisable if not mandatory to include the characterization processes presented in this review in future studies.
生物包封是指将组织或生物活性物质包裹在半透膜中。已证明生物包封在模拟细胞自然环境方面是有效的，从而提高了不同代谢物和治疗剂的生产效率。其应用领域广泛，正在生物产业和生物医学中得到应用，临床上用于治疗多种内分泌疾病。在过去几十年里，已经描述了许多制备胶囊的方法。不幸的是，这些方法大多缺乏对生物胶囊特性的充分记录。结果，许多方法在不同实验室之间存在极大差异，许多结果无法得到充分重现。胶囊的特性表征再也不能被忽视，特别是因为已经启动了生物包封治疗细胞的新临床试验，并且生物包封的工业应用正在不断增长。在本综述中，我们讨论了鉴于临床和工业应用而生产和表征生物胶囊的新方法。生物包封中的一个主导因素是选择和表征合适的聚合物。我们展示了使用高分辨率核磁共振表征聚合物的适用性。这些聚合物用于生产半透膜。我们指出了当前应用方法的缺陷，并为标准化提供建议以避免不同实验室之间的差异。此外，我们比较并展示了为特定应用领域生产生物相容性生物胶囊的方法，并且我们展示了诸如傅里叶变换红外光谱、X射线光电子能谱和飞行时间二次离子质谱等物理化学技术如何有助于生物包封过程的可重复性和标准化。近年来越来越明显的是，生物包封需要一种多学科方法，将生物医学、物理和化学技术结合起来。为了获得足够的可重复性并理解生物胶囊结果的差异，如果不是强制性的话，建议在未来的研究中纳入本综述中介绍的表征过程。
