Nanodrug production system/GMP/MPE-P3 MICROFLUIDIC PREPARATION EQUIPMENT

MICROFLUIDIC PREPARATION EQUIPMENT

简介

ITESEN Micro流体制备系统定位于微纳复合物注射剂的科学研究和应用。通过专利微流控芯片、高度集成和系统的硬件系统（如输送泵系统、PAT工具包等），以及以工艺应用为导向的人性化软件系统，为脂质体、LNP、微乳液、微晶、微球等不同药物递送载体的科研和产业化应用提供成熟、多样化的解决方案。基于AITESEN微流控技术的设备和解决方案已应用于多种临床和上市药物的研究和产业化。

MPE-P3 MICROFLUIDIC PREPARATION EQUIPMENT

MPE-P3 MICROFLUIDIC PREPARATION EQUIPMENT

MPE-P3 is a production type of Microfluidic Preparation System widely used in approved clinical mRNA vaccine projects, pre-IND nucleic acid drug projects, and FDA approved IND applications.

MPE-P3 is designed and manufactured in accordance with GMP requirements, providing a complete set of GMP validation documents. The operating system software has rich functions and can be used for continuous preparation and online dilution of LNP samples, as well as for GMP production of samples for different projects and processes. The PLC control system is quipped with a formula program that allows for flexible formulation of sample production strategies. Equipped with audit tracking function, in compliance with FDA 21 CFR part 11 requirements.

MPE-P3 supports customization, which can be customized according to different requirements such as process parameters, upstream and downstream linkage strategies, site constraints etc.