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

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Published on: March 17, 2023

Risk Assessment Approach to Microbiological Controls of Cell Therapies.

Tony Cundell¹, Scott Drummond², Irving Ford³

¹Microbiological Consulting LLC, Scarsdale, NY; tonycundell@gmail.com.

PDA Journal of Pharmaceutical Science and Technology

|January 17, 2020

Summary

This summary is machine-generated.

This review details a risk-based strategy for preventing microbial contamination in gene and cell therapy manufacturing. It covers the entire process, from donor selection to final product release, ensuring product safety.

Keywords:

Adventitious viruses Bacterial endotoxin Biological safety cabinets Cell collection Cell therapies Cell transformation and expansion Donor selection In-process sterility testing Isolator systems Microbial contamination Mycoplasma Rapid microbial detection testing Restrictive access barrier systems Risk-based approach Sterility

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Area of Science:

Pharmaceutical Microbiology
Cell and Gene Therapy Manufacturing

Background:

Cell and gene therapies represent a rapidly growing field with unique manufacturing challenges.
Microbiological contamination poses a significant risk to the safety and efficacy of these advanced therapies.

Purpose of the Study:

To present a comprehensive technology review on microbiological contamination control in gene and cell therapy production.
To outline a risk-based approach for detecting and managing microbial contaminants throughout the manufacturing process.

Main Methods:

Review of current technologies and strategies for microbial detection.
Risk analysis applied to critical stages of cell and gene therapy production.
Discussion of regulatory considerations for microbial control.

Main Results:

Identification of key risk points for microbial contamination from donor selection to product administration.
Evaluation of various testing methods for early and accurate detection of microbial contaminants.
Emphasis on a proactive, risk-based approach over traditional end-product testing.

Conclusions:

Implementing a robust, risk-based microbiological control strategy is essential for ensuring the safety of gene and cell therapies.
Continuous monitoring and risk assessment are crucial throughout the manufacturing lifecycle.
This approach supports the development of safe and effective cell and gene-based medicinal products.