Betekenis van:
somatic cell

somatic cell
Zelfstandig naamwoord
    • any of the cells of a plant or animal except the reproductive cells; a cell that does not participate in the production of gametes
    "somatic cells are produced from preexisting cells"

    Synoniemen

    Hyperoniemen

    Hyponiemen


    Voorbeeldzinnen

    1. Somatic cell therapy medicinal product
    2. Somatic cell count (per ml)
    3. ISO 13366-1 for the somatic cell count.
    4. Specific requirements for somatic cell therapy medicinal products
    5. somatic cell mutagenicity tests in vivo, in mammals; or
    6. In vivo somatic cell mutagenicicty tests, such as:
    7. The biodistribution, persistence and long-term engraftment of the somatic cell therapy medicinal product components shall be addressed during the clinical development.
    8. which meets the plate and somatic cell count standards laid down in Chapter IV of Annex A to Directive 92/46/EEC, and
    9. meets the plate and somatic cell count standards laid down in Chapter IV of Annex A to Directive 92/46/EEC;
    10. research activities intended to create human embryos solely for the purpose of research or for the purpose of stem cell procurement, including by means of somatic cell nuclear transfer.
    11. If there is a positive result from an in vivo somatic cell study available, the potential for germ cell mutagenicity should be considered on the basis of all available data, including toxicokinetic evidence.
    12. For somatic cell therapy medicinal products where the mode of action is based on the production of defined active biomolecule(s), the pharmacokinetic profile (in particular distribution, duration and amount of expression) of those molecules shall be addressed, if feasible.
    13. If there is a positive result in any of the in vitro genotoxicity studies in Annexes VII or VIII, a second in vivo somatic cell test may be necessary, depending on the quality and relevance of all the available data.
    14. to permit the use for the manufacture of certain dairy products of raw milk not meeting the criteria laid down in Annex III, Section IX, as regards its plate count and somatic cell count;
    15. For genetically modified cells, in addition to the specific requirements for gene therapy medicinal products, the quality requirements for somatic cell therapy medicinal products and tissue engineered products (see section 3.3) shall apply.