Evaluate the presence of viable production organisms in your final product using regulatory-aligned microbiological methods.
Assessment of the presence of viable cells is performed to determine whether living production organisms are present in the final product. This is a key requirement for microbial-derived products such as enzymes, food additives, and fermentation products. The objective is to demonstrate absence of viable cells within defined detection limits using well-established microbiological methods, in line with regulatory expectations.
This service is intended for companies developing microbial products for food, feed, and industrial applications, particularly where regulatory frameworks such as EFSA require evidence that the production strain is not present in the final product. It is especially relevant for non-QPS strains and genetically modified production organisms.
Testing is conducted using culture-based methods under conditions optimised for recovery of the production strain. Where colonies are observed, molecular identification methods such as PCR and sequencing are applied to confirm whether they originate from the production strain.
Clients receive a comprehensive report detailing study design, detection limits, test conditions, and results. The report clearly states whether viable cells were detected and provides a regulatory interpretation consistent with EFSA expectations. All outputs are structured for direct inclusion in regulatory dossiers.
We define and optimise culture conditions to ensure reliable recovery of the production strain, including evaluation of selective media where needed.
A pilot test is conducted to confirm method suitability and establish detection sensitivity.
Product samples are analysed using culture-based methods to assess the presence of viable cells.
Observed colonies are confirmed using molecular techniques, and results are translated into a regulatory-ready report.
Consistent with EFSA expectations for viable cell assessment
Optimised detection methods for low-level contamination
Combination of culture-based detection and molecular confirmation
Structured outputs for regulatory submission
Assessment of the presence of viable cells is required to demonstrate that the production organism is not present in the final product within defined detection limits. This is a key requirement under regulatory frameworks such as EFSA, particularly for non-QPS and genetically modified strains
Viable cells are detected using culture-based methods that allow growth of the production strain under optimised conditions. These methods are designed to maximise recovery and detect low levels of viable microorganisms
The detection method is optimised by selecting appropriate media, incubation conditions, and selective agents to ensure efficient recovery of the production strain while minimising interference from background microbiota.
Colonies are further analysed using molecular methods such as PCR and sequencing to determine whether they originate from the production strain or from environmental contamination.
The detection limit depends on the product matrix and test design and is established during method development. It is reported as part of the study to define the sensitivity of the assessment.
Genomic identification and safety assessment of production strains
Demonstrate absence of residual DNA from production organisms
In vitro assessment of potential toxic effects of microbial metabolites
Ensure your product meets regulatory expectations with a validated viable cell assessment strategy. Speak with our experts to design a compliant approach tailored to your process.
