Monoclonal antibody (Mabs) containing medicinal products are widely used in clinical practice. Prior to parenteral administration, licensed Mab containing medicinal products are transferred to the ready-to-administer (RTA) forms. Reconstitution and/or preparation should follow the guidelines for Good Reconstitution/Good Preparation Practice. Preparation in the pharmacy must take place within the framework of a suitable quality management system. The responsible pharmacist must apply a risk assessment on the process to ensure the appropriate quality of the RTA preparation, especially because the extent of quality testing is limited by batch size (often one single unit) and time restraints. In these cases, appropriate quality is to be assured by means of qualification activities, environmental monitoring, process validation with growth medium and in-process controls. Correct labelling of the Mab containing RTA preparations includes a suitable storage advice and a defined shelf life. Physicochemical stability of a given Mab preparation can be assessed based on a specific stability study (supplied by the manufacturer in the SmPC or scientific journals, study published by an expert in a peer-reviewed scientific journal). Physicochemical stability studies require the use of various orthogonal physicochemical methods to detect accurately the degradation changes that may result from the deamidation, oxidation, disulfide formation, aggregation or fragmentation during storage. Complementary, biological activity can be measured. Compatibility studies of Mabs and devices used for preparation and administration are still scarce. Microbiological stability of Mab preparations is related to the complexity of the preparation process, the growth supporting nature of the preparation and the integrity of the container or container/closure combination. In use viability tests revealed that the potential of Mab preparations to support microbial growth was similar to that of the pure vehicle solutions used as control solutions. The enumerated microbial counts varied according to the species utilized and the type of Mab preparation. If sterility testing of the individual preparation is impossible, maximum permitted shelf life can be assessed empirically with regard to the maximum shelf lives defined in the USP <797> monograph. Finally, microbiological and physicochemical stability are to be considered concurrently when determining the shelf life of an individual Mab preparation. In each case, shelf life should be limited according to the shorter period of proven stability, either derived from the microbiological or physicochemical stability data.

中文翻译：

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生物药品的配制和管理”。

含有药物的单克隆抗体（Mabs）在临床实践中被广泛使用。在肠胃外给药之前，将含有许可的Mab药用产品转移到即用型（RTA）表格中。复原和/或准备工作应遵循“良好复原/准备工作良好做法”的准则。药房中的制剂必须在适当的质量管理体系的框架内进行。负责任的药剂师必须对过程进行风险评估，以确保RTA制剂的适当质量，特别是因为质量测试的程度受批次大小（通常是一个单位）和时间限制的限制。在这种情况下，应通过资格认证活动，环境监测，使用生长培养基和过程控制进行过程验证。包含RTA制剂的Mab的正确标签包括适当的存储建议和明确的保质期。可以根据特定的稳定性研究（由SmPC或科学期刊中的制造商提供，由同行评审的科学期刊中的专家发表的研究）评估特定Mab制剂的理化稳定性。物理化学稳定性研究要求使用各种正交物理化学方法来准确检测在存储过程中由于脱酰胺，氧化，二硫键形成，聚集或断裂而引起的降解变化。可以测量互补的生物活性。用于制备和给药的单克隆抗体和设备的兼容性研究仍然很少。Mab制剂的微生物学稳定性与制剂过程的复杂性，制剂的生长支持特性以及容器或容器/密闭容器组合的完整性有关。使用中的生存能力测试表明，单克隆抗体制剂支持微生物生长的潜力与用作对照溶液的纯载体溶液的潜力相似。所列举的微生物数根据所用物种和单克隆抗体制备物的类型而异。如果不可能对单个制剂进行无菌测试，则可以根据USP <797>专论中定义的最大保质期凭经验评估最大允许保质期。最后，确定单个单克隆抗体制剂的货架期时，应同时考虑微生物和理化稳定性。在每种情况下，都应根据从微生物或物理化学稳定性数据得出的已证实的稳定性的较短时间来限制保存期限。