Cytocentric measurement for regenerative medicine

Area of Science:

• Regenerative Medicine
• Biotechnology
• Cell Biology

Background:

• Regenerative Medicine (RM) businesses need predictable cell and tissue products for regulatory approval.
• Current laboratory tissue production lacks predictability and control, hindering clinical applications.
• Understanding and quantifying cellular and pericellular needs is crucial for RM advancements.

Purpose of the Study:

• To identify critical cell and process parameters for reproducible cell and tissue product manufacturing.
• To review existing and needed technologies for monitoring cell and tissue cultures.
• To emphasize the importance of cytocentric measurements for RM industry maturation.

Main Methods:

• Identification of critical cell quality attributes (CCQAs).
• Review of sensing technologies for cellular and pericellular environments.
• Analysis of monitoring technologies for 2D and 3D cell cultures.

Main Results:

• Key cell and process parameters influencing product quality were identified.
• Available technologies for sensing these parameters were cataloged.
• Gaps in current monitoring technologies for reliable manufacturing were highlighted.

Conclusions:

• Cytocentric measurement of cell and tissue quality attributes is essential for the RM industry.
• Standardized quality control is necessary for the maturation of RM manufacturing.
• Further technological development is needed for robust monitoring of cell and tissue production.