A number of incidents have occurred with respect to vaccines, human tissue, and blood or body fluid derived plasma proteins: all of them have been related to virus contamination and infection.

A serious concern for biotechnically manufactured rDNA-derived proteins from recombinant mammalian cell cultures and monoclonal antibodies derived from hybridoma cell cultures is the potential risk of contaminating retroviral particles or adventitious virus.Although any cell line considered to become a master cell bank (MCB) for manufacturing is extensively tested for any potential infective virus, the presence of an unknown and/or undetected but potentially harmful virus cannot be dismissed. The presence of virus-like-particles (VLP's) detected by electron microscopy can be demonstrated for hybridoma cells and many recombinant mammalian cells.

More About Biopharmaceuticals Biotechnology Plasma Products