Viral Safety Perspective from the Paul-Ehrlich-Institut in Europe | PDA Journal of Pharmaceutical
Science and Technology Skip to main content Main menu Home Content Current Issue Past …

Providing a definition for virus safety is nebulous at best. Industry and regulators recognize
that the holy grail of viral safety—absolute freedom from extraneous agents or residual …

The 2023 Viral Clearance Symposium (VCS) was hosted by Takeda on 24 and 25 May 2023
in Vienna, Austria. The present conference extended the structure of the previous biennial …

Objective This manuscript aims to provide an overview of the unique considerations and
best practice principles associated with the manufacture of human viral challenge agents …

During the past five years or so, FDA has been more stringent about virus clearance studies.
Although rare, cases exist of viral contamination of cell substrates, production facilities, and …

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

Antiviral therapies - ScienceDirect Skip to main contentSkip to article Elsevier logo Journals &
Books Search RegisterSign in View PDF Download full issue Search ScienceDirect Elsevier …

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

Viral clearance and inactivation by the bulk protein purification process are a critical
component of the overall strategy to ensure the safety of therapeutic proteins derived from …

Remarkable progress has been made in antiviral chemotherapy. Six approved antiviral
drugs are now available for the treatment of various viral infections. Trifluridine, idoxuridine …