Modular industrial unit for pharmaceutical production

A portable system for producing a formulation comprising lipid nanoparticle (LNP) encapsulated RNA, comprising: a first subsystem comprising a plurality of pharmaceutical substance preparation modules, the first subsystem comprising: a transcription module for forming an RNA solution via in vitro transcription; and a second subsystem operably located downstream of the first subsystem comprising a plurality of drug product forming modules, the second subsystem comprising: an LNP formulation module for producing a first RNA-LNP formulation from an RNA solution wherein each of the transcription module and the LNP formulation module is contained in a separate standard shipping container. 一种用于生产包含脂质纳米颗粒(LNP)包封的RNA的配制品的便携式系统，其包括：包括多个药物物质配制模块的第一子系统，第一子系统包括：用于经由体外转录形成RNA溶液的转录模块；以及可操作地位于第一子系统下游的包括多个药物产品形成模块的第二子系统，第二子系统包括：用于从RNA溶液生产第一RNA-LNP制剂的LNP配制模块，其中转录模块和LNP配制模块中的每一者均被包含在单独的标准装运容器中。