Scientific Publications by FDA Staff

PDA J Pharm Sci Technol 2016 Mar-Apr;70(2):177-88

Meeting Report: 2015 PDA Virus & TSE Safety Forum.

Willkommen H, Blumel J, Brorson K, Chen D, Chen Q, Groener A, Kreil T, Ruffing M, Ruiz S, Scott D, Silvester G

The report provides a summary of the presentations at the Virus & TSE Safety Forum 2015 that was organized by the Parenteral Drug Association (PDA) and held in Cascais, Portugal, from 9th to 11th June, 2015. As with previous conferences of this series, the PDA Virus & TSE Safety Forum 2015 provided an excellent forum for the exchange of information and opinions between the industry, research organizations and regulatory bodies. Regulatory updates on virus and TSE safety aspects illustrating current topics of discussion at regulatory agencies in Europe and the U.S. were provided; the conference covered emerging viruses and new virus detection systems that may be used for the investigation of human pathogenic viruses as well as the virus safety of cell substrates and of raw material of ovine/caprine or human origin. Progress of development and use of Next Generation Sequencing (NGS) methods was shown by several examples. Virus clearance data illustrating the effectiveness of inactivation or removal methods were presented and data provided giving insight into the mechanism of action of these technologies.