Bacteria Detection

Bacterial contamination is a common and often invisible threat in cell culture workflows —compromising experiments and cell lines in R&D, and becoming a critical safety risk in ATMP manufacturing, as contaminated products can endanger patients.

Bacteria contamination in ATMP manufacturing:

A major challenge in ATMP manufacturing and testing is maintaining sterility throughout the entire production process. Since any contamination can pose serious risks to patients, reliable sterility testing is essential—ideally with results available before administration.

Bacteria contamination in research and development (R&D):

Early bacteria detection in cell culture is critical to protect valuable cell lines and prevent costly laboratory failures. Studies show, that even in professional laboratory settings, up to 5–10% of cell cultures may be affected by bacterial contamination – often without any obvious visible warning signs. These contaminations can lead to unpredictable effects on cell metabolism, growth, and differentiation. In addition, many common bacterial contaminants are antibiotic-resistant (e.g., to penicillin/streptomycin), making reliable bacterial contamination testing essential for routine cell culture work.

Our solution: PCR-based bacteria detection kits

Minerva Biolabs offers a targeted portfolio of PCR-based bacteria detection kits for bacterial contamination control:

Venor® Bacteria qPCR is a real-time PCR assay for rapid detection of bacterial contamination in cell cultures, cell culture-derived biologicals, and Advanced Therapy Medicinal Products (ATMPs). This assay provides a fast and accurate alternative for sterility testing of ATMPs and other short shelf-life products.

Onar® Bacteria is suitable for routine screening of cell cultures in R&D environment with conventional PCR followed by gel electrophoresis.

Unlike traditional culture-based methods, PCR-based bacteria detection kits also detect slow-growing bacteria and viable but non-culturable (VBNC) bacteria.