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Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

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Creating a GMP cell processing program: A focus on quality and regulation.

Darshan Patel¹, Jane Reese Koç², Folashade Otegbeye³

¹Therapeutic Products Program, Fred Hutchinson Cancer Center, 1100 Fairview Ave. N, Seattle, WA, 98109, USA.

Best Practice & Research. Clinical Haematology

|April 24, 2025

Summary

This summary is machine-generated.

Establishing Good Manufacturing Practice (GMP) in early cell therapy studies ensures product safety and quality. This review details creating a quality management program for academic settings, covering the entire cell therapy lifecycle.

Keywords:

Cell processing facility Good manufacturing practice Quality management program

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Area of Science:

Cellular and Molecular Medicine
Biotechnology
Regulatory Science

Background:

Implementing Good Manufacturing Practice (GMP) is essential for the safety and quality of cell-based therapies.
Academic research programs require guidance for establishing GMP-compliant cell processing.

Purpose of the Study:

To outline comprehensive steps for developing a robust GMP-compliant cell processing program in academic settings.
To provide guidance on establishing a Quality Management Program (QMP) for the cell therapy product lifecycle.

Main Methods:

Review of prevailing quality principles and guidelines from regulatory agencies (e.g., FDA, EMA).
Focus on common requirements for GMP adherence in cell therapy manufacturing.
Framework development for a Quality Management Program (QMP).

Main Results:

A detailed approach to establishing a GMP-compliant cell processing program.
Identification of critical factors across the cell therapy product lifecycle (procurement to administration).
Emphasis on qualified staff, clear procedures, facility/equipment qualification, and material control.

Conclusions:

A comprehensive QMP is vital for assuring quality outcomes in cell therapy.
Continuous process improvement and trend detection are key components of GMP.
Adherence to GMP principles from early phases is critical for safe and reproducible cell-based therapies.