Cells and tissues
Cell cultures result from the in vitro growth of cells from multicellular organisms and are categorised as biological agents in Article 2 of Spanish Royal Decree 664/97.
Cell lines in themselves do not present any risk, in the sense that they cannot be disseminated as such, cannot transfer genetic material by accident and have little chance of survival in non-sterile environments. However they can be carriers of pathogenic microorganisms - by contamination, by transformation or by recombination - and the fact that they are grown in conditions that are different to those found in the organism (pH, temperature, culture complement, etc.) may modify their oncogene or surface protein expression and cause latent viruses to be expressed or induce genome reorganisations. For this reason it is a requirement to assess the level of risk associated with each line.
Cell lines can be contaminated by bacteria, fungi, mycoplasmas, viruses and prions and, in particular, by bloodborne pathogens. Therefore, all non-fixed tissues and cells of human and/or no human primate origin must be considered infectious and must be manipulated in a BSL-2 at least. Tumour cells are also a potential hazard in case of autoinoculation.
All work must be carried out in a BSC and waste must be treated, by autoclave or by chemical disinfection, before being eliminated. Techniques or experiments with autologous cells from manipulators themselves are strictly forbidden since the immune protection mechanisms are short-circuited. All personnel must be offered the opportunity to be immunised against Hepatitis B and must undergo a health evaluation after any exposure incident.