FAQ — Got a question? Get your answer.

Samples and shipment

• Where can I send samples to? How much should I send, and in what form (agar plug, freeze-dried?)

  • We have collected detailed information related to samples and their shipment here.

• For the analysis of the absence of cells, and the presence of DNA in fermentation products, do I have to send the viable production strain?

  • Yes, if the study is going to be submitted as part of an EU application. In both analyses, the strain, or DNA isolated from the viable strain, is used as a positive control. All samples are handled highly confidentially, and are destroyed after completion of the project.

• How do I send the genome sequence data to Biosafe?

  • You may use cloud services for sending raw data. The assembled sequence can usually be transferred by (secured) e-mail.

Services

• Will you design primers for analysing the presence of DNA based on the amino acid sequence of the inserted gene?

  • No. Normally we need the whole genome sequence of the microbial strain. The targeted fragment must not exceed the size of the smallest antimicrobial resistance gene (AMR) in the genome, or if no AMR gene is present, the maximum size is 1000 bp. The targeted fragment must also be specific for the strain, which means that usually the insert junction site is the preferred target.

• How do I order services from you?

  • Please contact any of our project managers, experts or info@biosafe.fi and tell us what kind of services you are interested in. We will be happy to discuss with you in more detail and provide you with an offer. Although we will always keep all customer information confidential right from the first contact, we will normally sign a non-disclosure agreement before moving to more detailed discussions.

• Does your genome safety assessment (bioinformatics) service include a list of genes of concern or also conclusions about the safety of the strain?

  • Our genome assessment follows the EFSA guidance (FEEDAP 2018; CEP 2019 Guidances on the characterisation of microorganisms used as feed additives or food enzymes, respectively). We screen the genome for genes of concern present in up-to-date databases, provide the results in table format, and assess the safety of each of the genes. Conclusions are drawn based on our expertise and experience on various microorganisms, current literature, MIC test values or other data available for the strain and the genome context where the genes locate. The report will be compatible with the EFSA requirements without further modification.

• We have already sequenced our strain, can Biosafe use the data?

  • Yes. In such case, it is your responsibility that the information delivered to us is compatible with EFSA requirements (e.g. DNA isolation). If sequencing reports are provided to us, we can incorporate the key parameters into the bioinformatics report.

• I have obtained diverging results for my strain from different MIC tests. Why is this?

  • Several factors affect the MIC results. For example, there are certain differences between ISO and CLSI standards, which may give rise to different results. Normally, the differences are related to different culture conditions, such as the medium, level of oxygen present during incubation, or the actual number of cells in the culture tested. For some antimicrobial & species combinations, the test may not give reliable results.

• Can Biosafe be in contact with EFSA/EC for us?

  • Yes, we can help you to communicate with the authorities.

• Is it possible to analyse 1 g or mL of a poorly soluble or insoluble product for the presence of DNA?

  • Yes, it is. Biosafe has been developing methods for all types of products ever since EFSA published the first draft guidance including this requirement, and so far we have succeeded in all cases.

Quality

• What quality standards do you follow?

  • Biosafe follows ISO 17025 and pursues accreditation in 2021. Our services are generally compliant with EFSA guidelines.

• Is your cytotoxicity test EFSA compliant?

  • Yes. We perform the cytotoxicity test according to the requirements written in the EFSA Guidance on the characterisation of microorganisms used as feed additives or as production organisms (2018).

• How have you managed data security issues?

  • Biosafe is committed to ensuring that it has a robust and comprehensive system of risk management in line with the requirements of its operating environment, like ISO 17025 and GDPR (General Data Protection Regulation 2016/679), and that the company follows good practices in risk management. All customer information and data are confidential, even without a separate NDA. Samples are also strictly confidential and are destroyed after completing the project or are stored safely according to customer needs.