Building Effective Multi-Year Process Development Programs II: Evolution Of Technology Platform Decisions

By Josephine Lembong & Jon A. Rowley

Estimating hMSC lot sizes for clinical manufacturing to develop an effective multi-year process development program is crucial, because the calculated target cell lot size dictates the final production platform needed for your therapeutic product. The next step is to determine the appropriate manufacturing platform for each unit operation that will meet the needs of those calculated hMSC lot sizes throughout clinical development. Having a solid plan in advance will help your company succeed at navigating the complex maze that is the path to market success.

The final decision regarding production platforms can overwhelm. Even though there is a certain goal in mind for the present time, you do want to keep it flexible and scalable for other potential applications in the future. In this blog we lay out the various scales of hMSC production and highlight the existing technology platforms for the different unit operations involved in the manufacturing process. This will help define the requirements that will guide the company’s multi-year process development program to meet projected future lot sizes.