Talk : « Nucleic Acid Testing for Mycoplasma detection: From regulatory requirements to GMP implementation »

Abstract:

Mycoplasma testing remains a critical regulatory requirement in the quality control (QC) of biologics, particularly for advanced therapy medicinal products (ATMPs), vaccines, and recombinant proteins. Traditional compendial methods, direct culture and indicator cell culture, while robust, are often time-consuming (up to 28 days) and require substantial sample volumes, which can be limiting for cell-based products.

In recent years, nucleic acid amplification techniques (NAT) have emerged as validated alternatives, offering improved sensitivity, faster turnaround times, and reduced sample requirements. These advantages are particularly relevant in the context of cell and gene therapies, where rapid release and limited material availability are significant constraints.

This presentation will provide practical insights into the implementation of NAT-based mycoplasma detection under GMP conditions, including:

• A comparison with traditional compendial methods (EP 2.6.7, USP <63>)
• Regulatory expectations, including the new European Pharmacopoeia guidelines (EP 12.2, April 2026)
• The importance of matrix validation and genome copy–based sensitivity thresholds
• Case study examples from QC environments highlighting challenges and solutions during method validation and routine integration

By focusing on both the strategic and technical aspects of NAT implementation, this session aims to support laboratories seeking to modernize their mycoplasma control strategies in compliance with evolving standards.