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Extractables and Leachables USA

October 26-28, 2020
Online

Poster Schedule

Efficient Management of Extractable & Leachable Data in Process Development
Sanji K. Bhal and Joe DiMartino

Analytical and numerical data collected and compiled for Extractable and Leachable (E&L) studies is often scattered among a variety of systems including email, Microsoft applications (e.g. Excel) and electronic notebooks, to name a few. While scientists have developed practices and processes to compile E&L data to help make decisions, it remains a tedious manual process where simple questions such as "what extractables have been found from material x?" are not easy to answer.

In this poster, we introduce Luminata®—a CMC decision support application that helps project teams address the challenge of effective data management across product development. Luminata enables scientists investigating drug products and enclosure systems to create E&L study maps from data processed in the software of their choice. E&L study data may be assembled from various systems, connecting analytical data with study conditions and observations, in a single software for easy sharing, streamlined access, and effective decision-support. The ability to store E&L study data in one searchable location facilitates risk-assessment of product enclosure materials in drug product development.