Virus safety of biopharmaceuticals produced in cells of animal origin is governed by
regulatory guidelines. It is ensured through raw material controls, cell substrate testing, and …

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

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

Process validation is an integral part of any manufacturing process. It assures a consistent
outcome during key manufacturing processes. Viral clearance validation studies do not meet …

Viral safety is required for biologics manufactured to treat human diseases. Although
significant improvements in ensuring viral safety have been made over the past few …

Summary The prelims comprise: Introduction Strategies for Viral Safety Virus Clearance
Calculation of the Clearance Factor Evaluation/Assessment of Methods for Virus Inactivation …

Available guidance documents, such as the International Conference on Harmonization
(ICH) Q5a: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of …

Demonstration of effective and consistent viral clearance by small scale models of
downstream processing, typically cited as logarithmic reduction value (LRV), is an important …

Viral clearance studies are mandated prior to entering clinical trials and for commercial
launch of biopharmaceuticals. These studies are a key component of risk mitigation to …

Biologics produced from CHO cell lines with endogenous virus DNA can produce retrovirus‐
like particles in cell culture at high titers, and other adventitious viruses can find their way …