Consortium Identifies Risks of Viral Contamination in Biopharma
Published:14 Jun.2020 Source:The Scientist
Nine of the 20 pharma companies that participated in a study had experienced at least one viral contamination event between 1985 and 2018.
In 2009, the pharmaceutical industry experienced one of the most costly viral contamination events in recent history. When Vesivirus 2117 made it into one of Genzyme’s bioreactors for producing certain drugs, the fallout was dramatic. Patients struggled with a shortage of Cerezyme to treat Gaucher disease and Fabrazyme to treat Fabry disease when production stopped to prevent the contaminated products from getting to market. The company paid $175 million in fines, before moving to a new manufacturing facility with third-party oversight. Competitors were awarded fast-track designations for drugs to treat the rare diseases for which these drugs were suddenly unavailable. As the value of the company decreased, Sanofi was able to aquire Genzyme.