Fast Track NAT-Based Mycobacteria Testing Using dPCR

Ensuring the safety of biologics manufactured in cell culture requires rigorous testing for mycobacteria, a genus that includes both high-risk pathogens and environmental species that threaten immunocompromised patients. Traditional compendial methods are often a bottleneck in production, requiring up to 56 days to reach a definitive result. This delay is particularly challenging for short-shelf-life products like Advanced Therapy Medicinal Products (ATMPs).

Modern digital PCR (dPCR) offers a sophisticated alternative by targeting specific gene regions to detect a broad range of mycobacteria in just four days. Beyond speed, this nucleic acid amplification technique (NAT) identifies slow-growing or non-culturable species that traditional culture methods might miss. Implementing these rapid molecular assays allows for faster contamination responses and maintains regulatory compliance with EP 2.6.7 standards. Explore the full technical breakdown to see how dPCR-based testing optimizes safety protocols and accelerates release timelines.