Manufacturing, characterization and control of cell-based medicinal products: challenging paradigms toward commercial use.
Manufacturing, characterization and control of cell-based medicinal products: challenging paradigms toward commercial use.
复制标题
基于细胞的医药产品的制造、表征和控制：商业用途的挑战范式。
作者：
P. Salmikangas;M. Menezes;I. Reischl;A. Tsiftsoglou;J. Kyselovič;J. Borg;S. Ruiz;E. Flory;J. Trouvin;P. Celis;J. Ancāns;M. Timón;G. Pantè;D. Šladowski;M. Lipnik;C. Schneider
在过去的十年中，大量基于细胞的药物产品已经在临床试验中用于治疗各种疾病和组织缺陷。然而，获得许可的产品和接近上市许可的产品仍然很少。挑战的一个主要领域是这些复杂产品的制造和质量开发，为此可能需要对细胞进行大量操作。虽然质量、安全性和有效性的范例也必须适用于这些创新产品，但它们的示范可能要求很高。证明生产工艺和批次之间的可比性对于细胞基药品可能是困难的。因此，开发应该建立在一个控制良好的制造过程和一个合格的产品，以保证非临床和临床研究数据的可重复性。
During the past decade, a large number of cell-based medicinal products have been tested in clinical trials for the treatment of various diseases and tissue defects. However, licensed products and those approaching marketing authorization are still few. One major area of challenge is the manufacturing and quality development of these complex products, for which significant manipulation of cells might be required. While the paradigms of quality, safety and efficacy must apply also to these innovative products, their demonstration may be demanding. Demonstration of comparability between production processes and batches may be difficult for cell-based medicinal products. Thus, the development should be built around a well-controlled manufacturing process and a qualified product to guarantee reproducible data from nonclinical and clinical studies.
影响因子：
23.9
作者：
Saha K;Jaenisch R
通讯作者：
Jaenisch R