Fully Automated Laboratory Robotic System for Automating Sample Preparation and Analysis to Reduce Cost and Time in Drug Development Process

摘要

We have developed a fully automated laboratory robotic system (FA-LAS) capable of conducting most of routine experiments. Main objectives for developing this novel robotic system are to streamline the analytical tasks by automating sample preparations and analytical procedures, and to ensure the safety of analysts by assigning risk-involving procedures, such as handling of highly active substances. FA-LAS integrates numbers of unique functional devices and is highly competent for analyses of various research and development products. Comparative evaluations of FA-LAS with conventional manual preparation for drug substances and pharmaceutical products' real quantitative high performance liquid chromatography (HPLC) tests fulfilled this study's targeted criteria, which are 100 ± 5% for accuracy and coefficient of variation (%CV) ≤ 3% for repeatability for both HPLC analyses of drug substances and pharmaceutical products. In addition, several advantages over conventional manual methods were confirmed, such as reducing “working hour” for analysts, eliminating “working-hour” restriction, and decreasing drastically lag time for each prepared sample toward HPLC analysis. FA-LAS's unique features will work as a bridge between the sample management system and automatic documentation system, and it will reduce drastically in human resources, budgets, and time frame for development of pharmaceutical products.