Ligand-Binding Assays in the 21st Century Laboratory: Recommendations for an Automated Data Interchange Process

Abstract

With the ever increasing speed with which data are generated and the continual implementation of new instrumentation, maximizing the efficiency of data management for ligand-binding assays (LBAs) remains an increasing challenge. At the American Association of Pharmaceutical Scientists Workshop on the 21st Century Bioanalytical Laboratory: Maximizing Quality and Efficiency through Innovation, the attendees recognized the need to address the issue of data management. The eSolutions team, made up of end users and vendors, was formed with this challenge in mind, under the 21st Century Laboratory initiative. The eSolutions team has identified the need for a fully automated data interchange process as the first step to optimizing data management. This will require at least two major advances. First, for instruments capable of capturing raw data and metadata, a common open-source data standard is critical. Software independent of instruments will need to be compatible with the common data standard. Secondly, vendors must ensure that instruments and data analysis systems that process LBA data are enabled for direct bidirectional, file-less transfer of data between laboratory information management systems (LIMS), and instrument systems. In many laboratories conducting assays, LBA data systems and laboratory instruments are often islands of information, separated by an ocean of non-communication. Multiple applications within the laboratories generate reams of data that are stored in separate, non-connected silos of files. Data translation is required to share the data stored within these files with a LIMS or other analytical software. At best, this can be resolved using information technology (IT) resources. However, in the worst case scenario, this translation is performed manually leading to tedious error-prone tasks that require additional quality control (QC) oversight. In order to meet US FDA 21 CFR Part 11 (Electronic Records Electronic Signatures, ERES) regulations, data transfer through a file-based process requires assurance that the data imported into the LIMS are the same data exported from the data acquisition instrument. Therefore, one way to increase laboratory productivity would be through the use of a file-less automated process for data interchange tasks. Automation offers the performance of tasks in a secure, repeatable, and consistent manner without human intervention. Additional benefits of implementing an automated data interchange include: Facilitation of results and metadata transfer from source laboratory instruments (e.g., plate reader) to a data processing system (e.g., a LIMS) The ability to automate laboratory business processes where the format-consistent data can be programmed to be parsed and read by computer software Consistency of data formats between versions of the same software Data comparability between software applications even from different vendors avoiding the business risk of having to maintain legacy systems in order to retain the ability to read stored proprietary raw data in the future While many LBA laboratories clearly see a need for an automated data interchange process, these laboratories must raise awareness of this requirement by supporting the eSolutions team in establishing this process as well as supporting those vendors who choose to participate in the effort. It is absolutely necessary to have active vendor participation to be successful. There is a compelling reason for instrument and software vendors to participate in the creation of an automated data interchange process and to support its adoption. Innovative vendors of LIMS and analytical software will benefit from not having to keep up with the ever changing landscape of data formats. The automated data interchange process also allow new instrument vendors to more easily comply with data management requirements of LBA laboratories, thereby increasing the likelihood that innovative technologies will be adopted. On the other hand, LBA laboratories should be willing to accept an increase in cost for applications to account for costs incurred during adoption of the process and to patronize vendors that adopt the automated data interchange process. In this article, we provide perspectives on the benefit to the LBA community (vendors and users) and what is required to establish an automated data interchange process for LBA data.