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…

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
…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…

Article Development of Purification for Challenging Fc-Fusion Proteins
Initial viral clearance studies for Fc-fusion A using flow-through cation exchange with conditions previously identified revealed ≥ 3.9 log reduction value (LRV) for X-MuLV. Relatively limited clearan…

Article Understanding Validation and Technical Transfer, Part 3
Understanding Validation and Technical Transfer, Part 3 Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies. Part 1 |…

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