Recalls threaten public confidence in vaccines and immunoglobulins

Quality defects and donor tissue history must be more carefully monitored to increase public acceptance if the biologics market is to succeed, according to a new report by business intelligence experts GBI Research.

The new report refers to the pattern emerging in drug recalls over recent years, which shows that vaccines and immunoglobulins, in particular, have failed to meet safety standards. Biologics are drugs that contain an active substance produced by or extracted from a biological living source, which can include humans, animals, cells or microorganisms. Biological products and biologics have definite risks, as they are often only partially understood at the time of approval, with a highly complex production and purification process.

Products extracted from human blood or plasma also carry the risk of contamination with pathogens from the donor. Biomedical Tissue Services (BTS) recalled human tissue in October 2005 after the company discovered that tissue may have been procured from donors without properly evaluated medical and social histories. This prompted companies such as Regeneration Technologies and Tutogen Medical to also recall human tissue products.