Search results for " virus reduction"
Article
Selecting a Comprehensive Bioburden Reduction Plan
Chromatographic steps, low pH, and chemical inactivation provide virus reduction during processing. Virus and sterile filtration prior to final fill ensure maximum bioburden reduction. This comprehens…
Article
Case Study: Virus Reduction of an Affinity Capture Step
In this study, the virus reduction of an affinity capture step was evaluated in a scale-down column format. The study was performed by a third-party viral testing laboratory in collaboration with a bi…
Article
Viral Clearance Challenges in Bioprocessing
Challenges remain for virus removal and validation.
Nov 1, 2014
By: Cynthia Challener, PhD
BioPharm International
Volume 11, Issue 27, pp. 42-44
Removal and inactivation of adventitio…
Article
Putting Viral Clearance Capabilities to the Test
The manufacturing limits of parameters in these steps that might have an impact on the virus reduction should be challenged in the virus validation studies prior to Phase III, to show the robustness o…
Article
Ensuring Viral Safety of Viral Vaccines and Vectors
European guidance states that if the virus reduction is reproducible and the influencing manufacturing parameters are well defined, chromatography could fit the criteria of an effective step (34). Chr…
Article
Selecting the Right Viral Clearance Technology
“Viral clearance steps can be broadly classified into three basic categories: well-understood steps that are known to consistently provide robust virus reduction; lesser understood steps that have bee…
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
Updating Viral Clearance for New Biologic Modalities
At Lonza, Berrie explains, automation is being used in virus reduction filtrations (VRFs) to improve the assurance that viral clearance claims have been attained.
This is accomplished by controlli…
Article
Genetic Vaccine Platforms Demonstrate Their Potential
In a pandemic, genetic vaccines offer several advantages over traditional approaches.
By Cynthia A. Challener
For a vaccine to be effective, the components of the disease o…
Article
Application of Quality by Design to Viral Safety
These steps can include UV-C irradiation (6), gamma irradiation (7), high-temperature short-time treatment (6, 8) and virus reduction filtration (9, 10). These measures may be optimized to reduce smal…