Search results for "Viral clearance studies"

Article Putting Viral Clearance Capabilities to the Test
Viral clearance studies assess the capability of a downstream process to remove or inactivate potential contaminants and are based on a scale-down model of a biopharmaceutical production process. The …

Article Viral Clearance Challenges in Bioprocessing
Viral clearance studies will also need to be designed differently in order to address the specific conditions associated with media supply, Ruppach adds. Facility design and process monitoring C…

Article Selecting the Right Viral Clearance Technology
Because viral clearance studies are typically outsourced, particularly by smaller companies, these data are often not generated until they are needed to support a regulatory submission. “One common pi…

Poster Reduce Risk of Failure in Your Virus Clearance Study by Choosing Robust Scale-Down Chromatography Tools
Viral clearance studies are usually performed using a scale-down model mimicking the large-scale process step. For chromatography steps, using a scale-down model limits the amount of sample and resin …

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 Viral Clearance: 7 Chromatography Column Considerations
Viral clearance studies are a critical part of the production of biologics. However, performing studies that are accurate and cost-effective can be challenging.  Here are seven things to conside…

Article Application of Quality by Design to Viral Safety
…hat remain within the process design space are not considered changes and do not require additional viral clearance studies. In addition, the impact of excursions during a production run can be confi…

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 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 Bioterminology: A Guide to the Biopharmaceutical Lexicon
Bioterminology: A Guide to the Biopharmaceutical Lexicon This lexicon was generated by the editors of BioPharm International magazine. Please feel free to email your suggestions for terms that s…

Next Page