Some stem cell lines may contain an endogenous virus or can be contaminated with exogenous viruses (even of animal origin) and may secrete viral particles or express viral antigens on their surface. Moreover, certain biotechnological products (e.g. bovine fetal serum, murine feeder cells) may contain prion particles. Viral and prion contamination of cell cultures and “feeder” cells, which is a common risk in all biotechnological products derived from the cell lines, is the most challenging and potentially serious outcome to address, due to the difficulty involved in virus and prion detection and the potential to cause serious disease in recipients of these cell products.
Stem cell banks should introduce adequate quality assurance programs like the microbiological control program and can provide researchers with valuable support in the standardization and safety of procedures and protocols used for the viral and prion testing and in validation programs to assure the quality and safety of the cells.
You need to be sure that you will get PURE stem cells culture.
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The new treatments of cell therapy based on the transplant of cells of human origin still have problems, such as the difficulties of culture and differentiation of the cells, the possibility of chromosomal alterations and potential for tumorigenicity. Of particular importance is the possibility of transmission of infectious diseases to the recipients of these cell products. Any microbial contamination of the donor’s biological products or introduced during manufacturing process can potentially present a serious hazard to recipients even if it is not an overt pathogen. The most common potential forms of contamination (e.g. bacteria (include mycoplasma), yeast, fungi) can be readily assessed on a routine basis (European Pharmacopeia, 2004a, 2004b; Cobo et al., 2005). However, viral contamination of cell cultures and feeder cells, which is a common risk in all biotechnological products derived from the cell lines, is the most challenging and potentially serious outcome to address, due to the difficulty involved in virus detection and the potential to cause serious disease in recipients of these cell products (Cobo et al., 2005).
To ensure the provision of safe and reliable cells and tissues for these applications, it is necessary to regulate the procurement, processing, testing, preservation, storage and distribution of all cells that will apply in the human body (Directive 2004/23/CE). Stem cell banks must assure the quality and safety of these cells, and these aims are particularly important in the avoidance of transmissible diseases like viral and prion infections that are difficult to diagnose. These establishments should introduce adequate quality assurance programs like the microbiological control program. In this respect, accredited stem cell banks can provide researchers with valuable support in the standardization and safety of procedures and protocols used for viral and prion testing and in validation programs to assure the quality and safety of the cells.
This review will discuss the methodology that should be used in the stem cell banks in order to assure the quality of cell and biotechnological products and avoid the transmission of infections, in particular those that involve virus and prion particles.
Some lines or cell cultures may contain an endogenous virus or can be contaminated with exogenous viruses, and may secrete viral particles or express viral antigens on their surface. Moreover, certain biotechnological products (e.g. bovine fetal serum) may contain prionic particles. The primary sources of potential viral and prionic contamination come from infected animal tissue used to prepare biological reagents and media, biological products from donors (e.g. bone marrow, preembryos) and contamination during laboratory manipulation. In addition, infected laboratory workers may cause contamination of stem cell lines during culture manipulation.
