Now delivered online and organised under the leadership of PDA in close cooperation with European regulatory agencies and the U.S. FDA, this session will provide an overview and updates on regulatory expectations and scientific investigations related to virus and TSE safety of biotechnology, plasma-derived, and cell-derived medicinal products. 

As in previous years, virus contamination of raw materials, as well as emerging viral threats, will be discussed. Appropriate risk mitigation strategies consisting of two elements: (1) Testing and processing of raw materials and (2) Virus removal/inactivation capacity of the processes used for the production of medicinal products will be taken into consideration.

Guideline ICH Q5A on viral safety evaluation of biotechnology products derived from cell lines of human and animal origin has always been a key regulatory document successfully ensuring the viral safety of biopharmaceuticals. After 20 years of successful implementation, this Guideline is now under revision, taking the technological developments in virus detection and virus reduction into account. You will have the opportunity to learn about the topics being discussed. This will also include the application of viral safety methods towards continuous manufacturing processes. 

By introducing Next Generation Sequencing (NGS), we are experiencing a revolution in virology, leading to ongoing discovery of new viruses and opening new horizons for research as well as for characterisation and control of biopharmaceutical production. The PDA Interest Group on Advanced Virus Detection Technologies (AVTIG) will meet, and you will hear about the latest efforts in standardizing and applying these techniques for the detection of viral contaminants in biotechnological production. 

This PDA Europe Virus Forum reliably provides attendees a unique opportunity for interactive discussion and benchmarking. Exchange of information between industry and regulators will improve the understanding and acceptance of new techniques, highlight new and emerging risks and explain new regulatory approaches.