Biopharmaceutical Process Evaluated for Viral Clearance

Viral clearance for biopharmaceutical downstream processes

2015 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 reduce the potential for iatrogenic transmission of pathogenic viruses. This paper reviews regulatory guidance and practical strategies for designing viral clearance studies. Essential elements of a developmental pha...

Viral Safety and Evaluation of Viral Clearance from Biopharmaceutical Products. Proceedings of a meeting. Bethesda, Maryland, USA, June 14-16, 1995.

Quality by design approach for viral clearance by protein a chromatography

Protein A chromatography is widely used as a capture step in monoclonal antibody (mAb) purification processes. Antibodies and Fc fusion proteins can be efficiently purified from the majority of other complex components in harvested cell culture fluid (HCCF). Protein A chromatography is also capable of removing modest levels of viruses and is often validated for viral clearance. Historical data ...

Evaluation of Viral Inactivation Efficacy of a Continuous Flow Ultraviolet-C Reactor (UVivatec)

Viral safety is an important prerequisite for clinical preparations of all biopharmaceuticals derived from plasma, cell lines, or tissues of human or animal origin. To ensure the safety, implementation of multiple viral clearance (inactivation and/or removal) steps has been highly recommended for manufacturing of biopharmaceuticals. Of the possible viral clearance strategies, Ultraviolet-C (UVC...

Proceedings of the 2009 Viral Clearance Symposium.

The 2009 Viral Clearance Symposium (Indianapolis, IN, USA) was held to interactively discuss methods for virus removal and inactivation during biopharmaceutical manufacture. Its origin was the result of worldwide regulatory and industry recognition that challenges, gaps, and opportunities for improvement exist, which if formally addressed could benefit the field as a whole. The symposium began ...