Bioprocess Modeling for Expansion of Cell Culture

Summary

This project develops scalable bioprocess models for controlled cell culture expansion, integrating real-time data collection and digital modeling to improve reproducibility and quality assurance in cell-based product manufacturing and reference material development.

Description

One of the most critical steps in bioprocessing is the controlled expansion of frozen cell cultures to generate sufficient cell quantities for manufacturing cell-based products or assay systems. This project focuses on building a scalable model for cell expansion processes that can support the development of NIST cell-based reference materials. The bioprocessing laboratory is equipped with internet-enabled instrumentation and database support from collaborators, enabling the development of comprehensive metadata and electronic laboratory notebooks for tracking and optimizing the expansion process.

A key application of this system is the digitization of gene-edited stem cell production, which may serve as a next-generation reference material for studying gene editing artifacts in a cellular context. The structured organization of cell expansion data within this framework is being leveraged to develop digital twins—virtual models of biological systems that facilitate reproducible expansion processes for living cellular materials. By integrating real-time monitoring, digital documentation, and modeling capabilities, this approach ensures that cell culture expansion processes remain standardized, reproducible, and adaptable for future biomanufacturing applications. The adoption of these advanced methodologies enhances confidence in cell-based assays and reference material production while enabling greater scalability and precision in bioprocessing workflows.