Issues In Assuring Virological Safety Of Biopharmaceuticals

Current Issues in Assuring Virological Safety of Biopharmaceuticals

Author: Hazel Aranha, Ph.D., Catalent Pharma Solutions, Editor, BioProcess International

Biologicals ushered in a new era for treating debilitating and life-threatening illnesses. According to a Pharmaceutical Research and Manufacturers of America (PhRMA) 2011 report, more than 900 biotech medicines and vaccines are in development that are targeting more than 100 diseases (1). Market researchers expect annual sales of biologics (now at about US$100 billion) to grow two to three times faster than conventional small-molecule drugs during the next five years (2). Advances in cell line development, bioreactor design, and purification techniques have led to a sevenfold increase in global protein output from mammalian cell cultures alone from 2000 to 2005 (500 kg versus 3,600 kg) (3).