Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), P.O. Box 31975-148, Karaj, Iran.
Arch Razi Inst. 2022 Dec 31;77(6):2023-2035. doi: 10.22092/ARI.2022.358890.2327. eCollection 2022 Dec.
Today, due to the importance of diseases controlled by vaccination, the production of biological products is of great importance in ensuring public health, so producing high-quality biological products plays an important role in maintaining public health. One of the most important principles of manufacturing high-quality and efficient biological products is using suitable seeds based on standard principles. To produce a suitable seed for continuous use for mass production of biological products, the seed must be defined according to certain principles and foundations. These principles are formed in the form of a seed lot system. In this review article, all the requirements for the establishment of a seed to produce a biological product include general seed information, including basic and seed information and microorganisms, seed-specific information including seed passage levels, propagation method, seed storage conditions, coding and labeling, identification information and design of suitable laboratories for passage, seed propagation, and storage, determination of seed characteristics including all necessary tests to determine seed identity, purity, potency, efficacy, stability, safety and also all the necessary information for documenting and storing seeds has been studied. Also, this study discusses the method of preparing all the necessary information for establishing a seed lot system, especially determining the characteristics of seeds. Based on the study's results, a complete and comprehensive seed lot system has been formed that can be used to prepare, propagate, passage, and store seeds used in the production of biological products.
现如今,由于疫苗控制疾病的重要性,生物制品的生产对于保障公共卫生至关重要,因此生产高质量的生物制品对于维护公共卫生起着重要作用。制造高质量、高效率生物制品的最重要原则之一是基于标准原则使用合适的种子。为了生产适合大规模生产生物制品的连续使用的合适种子,必须根据某些原则和基础对种子进行定义。这些原则以种子批系统的形式形成。在这篇综述文章中,建立用于生产生物制品的种子的所有要求包括一般种子信息,包括基本和种子信息和微生物,种子特异性信息包括种子传代水平、繁殖方法、种子储存条件、编码和标记、适合传代、繁殖和储存的实验室的鉴定信息和设计,种子特征的确定,包括确定种子身份、纯度、效力、功效、稳定性、安全性所需的所有必要测试,以及记录和储存种子所需的所有必要信息。此外,本研究还讨论了制备建立种子批系统所需的所有必要信息的方法,特别是确定种子特性的方法。基于研究结果,形成了一个完整而全面的种子批系统,可用于制备、繁殖、传代和储存用于生产生物制品的种子。