Building Effective Multi-Year Process Development Programs I: Estimating hMSC Lot Size Ranges

By Josephine Lembong & Jon A. Rowley

The goal of any process development program is to create a right-sized manufacturing process for your immediate business goals but with future scalability in mind. Understanding the future lot size requirements will help strategically align manufacturing requirements today—with commercial scalability—while laying a platform foundation to minimize comparability risks.

hMSC lot size estimation is crucial for creating a clinical and commercially viable biomanufacturing process. In this blog we outline a development program that could tailor accordingly to meet your final product platform needs, with target cell lot size foremost in mind.