The 2009 Viral Clearance Symposium (Indianapolis, IN, USA) was held to interactively
discuss methods for virus removal and inactivation during biopharmaceutical manufacture …

Virus filtration has been demonstrated to be an effective and robust dedicated viral
clearance step that is used in biopharmaceutical manufacturing processes. Here we present …

Considerable resources are spent within the biopharmaceutical industry to perform viral
clearance studies, which are conducted for widely used unit operations that are known to …

The viral safety of biotechnology products has traditionally been a key concern both of
regulators and industry. 1-6 It has also proven to be a stumbling block for early product …

Log reduction factor: When evaluating viral reduction for a given process step, the reduction
is the difference between the total virus in the spiked load sample and the total virus in the …

Ensuring the absence of detectable viruses in biopharmaceutical products is imperative from
both a regulatory and patient safety standpoint. Biopharmaceutical viral safety is the result of …

The successful implementation of any biologically derived product in human clinical trials
and as a marketed biopharmaceutical requires the critical utilization of effective viral …

The workshop was held on 27 June 2011 in Barcelona, in conjunction with the PDA Virus &
TSE (transmissible spongiform encephalopathy) Safety Forum 2011. Virus-retentive filters …

For drug products manufactured in mammalian cells, safety assurance practices are needed
during production to assure that the final medicinal product is safe from the potential risk of …

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