Viral Clearance

Rapid Detection of Pandemics

A Coronavirus — like severe acute respiratory syndrome (SARS) — is back in the headlines. On returning from a trip to Saudi Arabia in summer 2012, a Qatari national was struck down by a mystery respiratory illness. Because of inadequate diagnostic capabilities, the patient was transferred from Qatar to London for intensive-care treatment and diagnosis. The UK Health Protection Agency (HPA) confirmed infection with the same Coronavirus strain discovered by a Dutch team following the death of a Saudi national…

Retention of Highly Penetrative A. laidlawii Mycoplasma Cells

    Mycoplasma are infamous for contaminating cell culture lines at rates as high as 80% (1,2,3,4,5). For biopharmaceutical processes, the inadvertent use of contaminated culture medium or medium components can lead to contamination of an aseptic process-validation media fill or cell culture medium for a bioreactor (6,7,8,9,10,11). Thoroughly testing medium components before use is generally impractical because of the large volume of material in use. Frequently, culture media cannot be autoclaved (because of the presence of heat-sensitive components or…

Current Issues in Assuring Virological Safety of Biopharmaceuticals

The weakest link in the chain is also the strongest. It can break the chain.— Stanislaw Jerzy Lec, Polish writer, poet and satirist (1906–1966) 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…