Title: Digital workflows: vignettes from crystallization and FLEx

Vignette 1: Crystallization (adapted from “Solubility in the age of a data lake”)

Crystallization is an important process often employed several times within synthetic routes for drug substances. The development of robust crystallization processes can be separated into two tasks: (1) the selection of a solvent-system, and (2) the design of a process within that solvent system that affords materials with desired chemical/physical purity and meets yield requirements. An end-to-end workflow relying on digital workflows for capturing, visualizing, and interpreting solubility data to facilitate the consistent and rapid execution of these tasks.

Vignette 2: FLEx-ible digital solutions for contextualization in clinical drug product manufacturing

The Formulation Laboratory and Experimentation (FLEx) Center is a novel drug product development and clinical supply manufacturing plant, built in alignment with Merck Research Lab’s flexible manufacturing strategy.  This strategy is composed of investments in technology, business processes, and people; and calls for digitally enabled facilities that can be rapidly configured to meet the needs of an evolving pipeline.  To deliver digital enablement within the FLEx center, a digital system architecture was developed with the purpose of contextualizing time-series data within a data lake using data from manufacturing and workflow execution systems. Delays in the deployment of these systems has resulted in the FLEx center producing time series data without a systematic (human-out-of-the-loop) approach to contextualizing trends within this data (e.g., identifying corresponding batches, events, product performance).  This talk centers around the development of a FLEx-ible approach to providing contextualization via a weekly data review series and the development of tools designed to deliver the capability to conduct such a series. 

Short Bio: Mike Lovette is a Sr. Principal Scientist in Merck’s Development Sciences and Clinical Supply Digital Technologies (DDT) organization. Prior to this role Mike was a Director of Data Science in Merck’s Pharmaceutical Sciences and Clinical Supply (PSCS) organization, leading the PSCS data science and informatics team. Where he was responsible for directing a team of data scientists and developers who collaborate to implement solutions across a broad range of digital needs. Before joining Merck, Mike worked for Amgen and Eli Lilly in the fields of drug substance process development and data science. He received his PhD in chemical engineering from the University of California Santa Barbara and his bachelor’s degree in chemical engineering from Northeastern University.

Host: Dr. Jason Shoemaker