Scientific Publications by FDA Staff

PDA J Pharm Sci Technol 2012 Nov 1;66(6):502-11

PDA/FDA Adventitious Agents and Novel Cell Substrates: Emerging Technologies and New Challenges, Nov. 3-4, 2011, Rockville, MD.

Khan AS, Lubiniecki A, King KE

In response to the challenges of addressing potential safety concerns related to the use of novel cell substrates, the Parenteral Drug Association (PDA) and the U.S. Food and Drug Administration (FDA) co-sponsored a conference on November 3-4, 2011 in Rockville, Maryland, USA. The following were discussed: the current adventitious agent testing methods and the use of emerging nucleic acid-based technologies for broad detection of known and novel viruses; issues associated with manufacture of biologicals in novel cell substrates such as insect cell lines and plants, with specific focus on potential safety concerns related to endogenous retroviral elements; and raw material controls and strategies to mitigate risk of adventitious virus contamination during product manufacture.