title: [Specific aspects for virus safety of raw materials for cellular-based medicinal products].
abstract: Virus safety of cell-based medicinal products is a particular challenge. These products are frequently manufactured using various human- or animal-derived starting and raw materials (serum and feeder-cells) in cell culture, which are possible sources for viral contamination. For living or proliferating cells, no methods for virus inactivation (such as heat or chemical treatment) can be used and the options for testing these medicinal products for all possible viral contaminations are very limited. As a consequence, other safety measures, in particular careful selection and testing of starting and raw materials, are very important. For raw materials, attention should be paid to cell-culture additives of biological origin, such as human and bovine serum and porcine trypsin. Whenever possible, manufacturing steps for inactivation and removal of viruses should be introduced as an additional safety measure. In addition, recombinant products from animal cell cultures (such as growth factors, monoclonal antibodies for cell sorting, viral vectors) are used and have to be tested for virus safety.
authors.affiliation: Fachgebiet Virussicherheit 2/3, Abteilung Virologie, Paul-Ehrlich-Institut, Paul-Ehrlich-Str. 51-59, 63225, Langen, Deutschland. Albert.Stuehler@pei.de.
authors.forename: Albert
authors.initials: A
authors.lastname: Stühler
authors.affiliation: Fachgebiet Virussicherheit 2/3, Abteilung Virologie, Paul-Ehrlich-Institut, Paul-Ehrlich-Str. 51-59, 63225, Langen, Deutschland.
authors.forename: J
authors.initials: J
authors.lastname: Blümel
mesh_terms: D001688:Biological Products / Q000009:adverse effects / Q000592:standards*; D064987:Cell- and Tissue-Based Therapy / Q000009:adverse effects / Q000592:standards*; D004337:Drug Carriers / Q000009:adverse effects / Q000592:standards*; D004340:Drug Contamination; D004345:Drug Industry; D010592:Pharmaceutic Aids / Q000592:standards*; D014776:Virus Cultivation / Q000592:standards*; D038301:Virus Inactivation
chemical_list: D001688:Biological Products; D004337:Drug Carriers; D010592:Pharmaceutic Aids
keywords: Cell therapy products; Cellular based medicinal products; Raw materials; Reagents; Virus safety