Implementation of automation capabilities on vaccine analytical research and development.

Traditional drug discovery has been progressively replaced by a combination of laboratory automation, high throughput and automated data analysis leading to a new era in the pharmaceutical industry. In the analytical space, assay automation provides multiple benefits, including better precision, standardization and improved efficiency compared to manual methods. This enables the handling of large numbers of samples. Despite these advantages, there are strategic challenges that persist in developing a suitable assay to support vaccine process at different development stages. Among many vaccine attributes, the accurate measurement of analyte across antigen production, purification and formulation processes is a cornerstone in the vaccine pipeline that can be determined by ELISA. At Merck, Vaccine Analytical Research & Development has developed an integrated platform, with a combination of plate washer, liquid handler and reader supported by a robotic arm for running automated ELISA. These instruments are controlled by a software that provides full integration of all devices. The Analytical team has developed and adapted this ELISA platform for use in multiple vaccine programs that are in development at Merck. Assay validation is a critical step and includes ensuring that certain criteria such as specificity, precision, accuracy, limit of quantification and robustness are assessed. In addition, any change during vaccine development needs to be assessed to determine the impact on reportable data, including the identification of the potential root cause of assay deviation. To meet the high sample demand, the data pipeline has also been automated, including sample submission, data analysis and report generation workflows. This has allowed for efficient data analysis and improvements in data visualization and the interpretation of historical data.