Sutton Ann
The Biologics Consulting Group, Alexandria, Virginia 22314, USA.
Clin Infect Dis. 2008 Feb 1;46 Suppl 2:S128-32; discussion S144-51. doi: 10.1086/523325.
Elements of product and manufacturing-process design are described for product development of live biotherapeutic biological drugs. Product design uses the history and the phenotypic and genotypic characterization of the selected strain. The quality and integrity of the selected strain can be ensured by preservation in a qualified cell-bank system. Manufacturing-process design includes step-by-step description, including the necessary process-input parameters and the expected output results. The active ingredients in the biological drug are usually manufactured using aseptic processing. The manufacture of the final dosage form of live biotherapeutics requires bioburden control or aseptic manufacture, as appropriate. Specifications for live biotherapeutics must comply with regulations for licensed biological products. Evidence of stability for the duration of the shelf life, as well as stability under the recommended conditions of use, must be provided for licensure.
描述了用于活生物治疗生物药物产品开发的产品和制造工艺设计要素。产品设计利用所选菌株的历史以及表型和基因型特征。所选菌株的质量和完整性可通过保存在合格的细胞库系统中来确保。制造工艺设计包括逐步描述，包括必要的工艺输入参数和预期的输出结果。生物药物中的活性成分通常采用无菌工艺生产。活生物治疗药物最终剂型的生产需要根据情况进行生物负荷控制或无菌生产。活生物治疗药物的规格必须符合许可生物产品的法规要求。必须提供有效期内稳定性以及推荐使用条件下稳定性的证据以获得许可。
