PDA/FDA Advanced Technologies for Virus Detection in the Evaluation of Biologicals Conference

13 - 14 November 2013, Bethesda, United States

Introduction

This conference will present and discuss considerations for use of novel virus detection technologies for the characterization of biological materials used in the production of vaccines and recombinant, therapeutic products. There has been no known case of a human infection due to the presence of any adventitious virus in a biological product. However, adventitious agents have been detected in biological materials used in product manufacture. Most recently, porcine circovirus and vesivirus were found in cells used in the manufacture of a rotavirus vaccine and a therapeutic product, respectively. These findings emphasize the need for broad-spectrum and sensitive assays to detect adventitious viruses and other microbial agents in biological products. Advanced virus detection methods such as massively parallel or deep sequencing, broad range PCR with mass spectrometry, and virus microarrays have demonstrated success in identifying novel viruses in some research, biological, and clinical samples. However, there are a number of factors to consider for using these methods to characterize biological materials used in manufacture. Approaches to address some of the critical issues related to sample processing and bioinformatics will be presented. An expert panel including representatives from industry and regulatory agencies will discuss these novel detection assays, their strengths and limitations and how they can be used to enhance the characterization provided by conventional assays.

Venue