The November 2013 workshop was organized by the Parenteral Drug Association (PDA)
and US Food and Drug Administration (FDA) to provide an open scientific dialogue between …

An informal consortium of scientists from the biopharmaceutical industry, academia, and
government agencies, including regulators, coalesced during 2013 to further explore …

CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in
Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December …

The testing for adventitious viruses is of critical importance during development and
production of biological products. The recent emergence and ongoing development of broad …

CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in
Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December …

In summary, this chapter reviews the principles of how the current and routine tests detect
adventitious agents, and reviews how novel and emerging methods differ in their detection …

CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in
Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December …

The Cell Banks, Advanced Technologies (ATMPs, NGS) session at the 2023 Viral Clearance
Symposium (VCS) focused on the assurance of high virus safety profiles of advanced …

Biologicals ushered in a new era for treating debilitating and life-threatening illnesses.
According to a Pharmaceutical Research and Manufacturers of America (PhRMA) 2011 …

Abstract The Consortium on Adventitious Agent Contamination in Biomanufacturing
(CAACB) collected historical data from 20 biopharmaceutical industry members on their …