GSK Vaccines Institute for Global Health (GVGH), Via Fiorentina 1, 53100, Siena, Italy.
The Sargent Centre for Process Systems Engineering, Department of Chemical Engineering, Imperial College London, South Kensington Campus, London, SW7 2AZ, UK.
AAPS J. 2024 Mar 8;26(2):32. doi: 10.1208/s12248-024-00902-0.
In recent years, Generalized Modules for Membrane Antigens (GMMA) have received increased attention as an innovative vaccine platform against bacterial pathogens, particularly attractive for low- and middle-income countries because of manufacturing simplicity. The assessment of critical quality attributes (CQAs), product-process interactions, identification of appropriate in process analytical methods, and process modeling is part of a robust quality by design (QbD) framework to support further development and control of manufacturing processes. QbD implementation in the context of the GMMA platform will ensure robust manufacturing of batches with desired characteristics, facilitating technical transfer to local manufacturers, regulatory approval, and commercialization of vaccines based on this technology. Here, we summarize the methodology suggested, applied to a first step of GMMA manufacturing process.
近年来，通用膜抗原模块（GMMA）作为一种针对细菌病原体的创新疫苗平台，受到了越来越多的关注，由于制造简单，对中低收入国家尤其具有吸引力。关键质量属性（CQA）的评估、产品-工艺相互作用、合适的过程分析方法的识别以及工艺建模是稳健设计质量（QbD）框架的一部分，可用于支持进一步开发和控制制造工艺。在 GMMA 平台的背景下实施 QbD 将确保具有所需特性的批次的稳健制造，促进向当地制造商的技术转让、监管批准以及基于该技术的疫苗的商业化。在这里，我们总结了所建议的方法学，并将其应用于 GMMA 制造工艺的第一步。
