(537f) Resilient Multi-Site Onboarding, Knowledge Transfer and Process Understanding of Commercial Drug Substance Manufacturing: Virtual Make-a-Batch Exercise

Amgen’s drug substance (DS) and attribute sciences (AS) teams demonstrated resilience to complete knowledge transfer of a commercial API which included the DS intermediates (DSI) and starting materials which are spread across multiple contract manufacturer organizations (CMOs). Despite global COVID-19 related restrictions, the teams successfully integrated an in-licensed commercial asset into the Amgen portfolio through the unique application of digital platforms for knowledge transfer, virtual cross-site Make-a-Batch exercises, which ensured successful delivery of multi-ton DS campaign across multiple sites.

Make-A-Batch (MAB) exercise is a platform used to facilitate an intense and thorough discussion of a chemical process with a manufacturing site, to promote knowledge transfer, process fit into the receiving facility capabilities, mutual understanding of execution of the process control strategy and identifying potential execution/knowledge gaps. This remains to be a critical activity during the technology transfer phase for Amgen assets but for the first time this platform was used for the integration of an in-licensed synthetics DS program into the Amgen system. To execute the exercise, a cross functional team with subject matter expertise collaborate to perform an assessment based on process knowledge and facility’s capability. An assessment captures the best possible implementation strategy for process transfer and identify potential gaps and misalignments of process/execution fit.

The Make-a-Batch exercise is usually conducted in face-to-face interaction but due to COVID-19 related travel restrictions, complexity of exercise and time constraints, the team modified the MAB process and then facilitated its execution through online interaction, offline review, and final agreement on outcome in terms of enhancing the process knowledge and information transfer of synthetic drug substance manufacturing.