Search results for "virus clearance"
Article
Viral Clearance Challenges in Bioprocessing
Processes with fewer purification steps present a challenge to virus clearance, however, because higher removal claims are expected with individual unit operations. “Access to high titer virus prepara…
Article
Updating Viral Clearance for New Biologic Modalities
Viral clearance processes and guidance must evolve along with newer biotherapeutic modalities.
By Feliza Mirasol
Ensuring viral clearance (i.e., removal) in downstream purification has becom…
Article
Putting Viral Clearance Capabilities to the Test
“Understanding the risks of viral contamination leads to the choice of viruses selected for a study, as well as the level of virus clearance required, to assure a safe product.”
Assessments should…
Article
Selecting the Right Viral Clearance Technology
By Cynthia Challener, PhD
The introduction of adventitious viral agents is a recognized, inherent risk of biologic drug production that is well addressed by international regulatory requirements…
Poster
Reduce Risk of Failure in Your Virus Clearance Study by Choosing Robust Scale-Down Chromatography Tools
Effective viral clearance studies remain one of the challenges facing manufacturers of biologics. These studies are an essential part of process validation and are critical to ensure drug safety. Vi…
Article
Fundamentals of Viral Clearance Studies with a Focus on Chromatography
Effective viral clearance studies remain one of the challenges facing manufacturers of biologics. These studies are an essential part of process validation and are critical to ensure drug safety. This…
Article
Application of Quality by Design to Viral Safety
…ants, and through an understanding of the impact of variations in processing parameters can have on virus clearance, the risk can be managed effectively and viral safety can be achieved.
Referenc…
Article
Ensuring Viral Safety of Viral Vaccines and Vectors
Ensuring Viral Safety of Viral Vaccines and Vectors
Viral vaccines and viral vectors used in biotherapeutic applications carry the risk of microbial contamination, which must be addressed.
…
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Testing product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk m…
Article
Development of Purification for Challenging Fc-Fusion Proteins
Development of Purification for Challenging Fc-Fusion Proteins
This study outlines methods for an alternative protein-polishing process for challenging proteins.
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