- 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"
- Somatic cell therapy medicinal product
- Somatic cell count (per ml)
- DETERMINATION OF PLATE COUNT AND SOMATIC CELL COUNT
- ISO 13366-1 for the somatic cell count.
- Specific requirements for somatic cell therapy medicinal products
- somatic cell mutagenicity tests in vivo, in mammals; or
- In vivo somatic cell mutagenicicty tests, such as:
- Specific requirements for somatic cell therapy medicinal products and tissue engineered products
- Somatic cell therapy medicinal product means a biological medicinal product which has the following characteristics:
- Biodistribution, persistence and long-term engraftment of the somatic cell therapy medicinal product components
- Emerging animal breeding technologies, such as animal cloning conducted by somatic cell nuclear transfer (SCNT), are used for research purposes.
- other in vivo somatic cell genotoxicity tests which are supported by positive results from in vitro mutagenicity assays.
- Somatic cell therapy medicinal products where the mode of action is based on the production of defined active biomolecule(s)
- National criteria for colostrum, as regards plate count, somatic cell count or antibiotic residues, apply pending the establishment of specific Community legislation.
- For somatic cell therapy medicinal products and tissue engineered products, producing systemically active biomolecules, the distribution, duration and amount of expression of these molecules shall be studied.