Search results for " Viral clearance studies" in Articles / App Notes
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
Challenges in study design
The multi-step nature of bioprocesses—and the viruses themselves—present challenges to the development of viral clearance studies and limit their effectiveness.
“All…
Article
Viral Clearance Challenges in Bioprocessing
“In order to perform high-quality viral clearance studies and avoid unreliable, inaccurate, or outdated viral clearance data, it is necessary to regularly review the manufacturing process and ensure t…
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
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
…that 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 conf…
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
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…