Viral Clearance Using Traditional, Well-Understood Unit Operations: Session 1.2. Anion
Exchange Chromatography; and Session 1.3. Protein A Chromatography | PDA Journal of …

In response to the strong demand of biological protein therapeutics, such as monoclonal
antibodies (MAbs), continuous downstream process was developed to deliver these …

The purification of monoclonal antibodies and Fc fusion proteins consist of several unit
operations operated commonly as a platform approach, starting with Protein A …

SHUKLA:“dk3347_c014”—2006/5/23—17: 58—page 419—# 114.1 Introduction......................
..................................... 420 14.2 Health Risk from Virus Contamination.............................. 421 …

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

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 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 …

The BioPhorum Development Group Viral Clearance Workstream performed a collaborative
retrospective analysis to evaluate packed bed chromatographic resin performance after …

Most chromatographic separations utilize columns packed with beads. The bead diameter is
an important factor: small beads result in fast diffusion times and large numbers of plates, but …

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 …