Search results for " virus filtration"
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Filtration methods to overcome new challenges in viral safety
41 and ICH Q5A, and outlines the detailed mechanisms governing effective virus filtration, demonstrating how both specific methods and advanced filter design can overcome these challenges.
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Viral Clearance Challenges in Bioprocessing
Generally, Greenhalgh notes that virus purity has the biggest impact on the virus filtration step: less purified preparations are more likely to negatively impact the virus filter performance by reduc…
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Ensuring Viral Safety of Viral Vaccines and Vectors
Options include high temperature/short time (HTST), C spectrum ultraviolet light (UV-C), gamma irradiation, and nano- or virus filtration.
HTST is commonly used in the food and beverage industr…
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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…
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Putting Viral Clearance Capabilities to the Test
Process understanding and careful assessment of risks are essential in developing viral clearance programs.
By Rita C. Peters
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Overview of a scale-up of a cell-based influenza virus production process using ReadyToProcess equipment
The aim of this white paper is to demonstrate how Cytiva single-use products can be applied in the field of vaccine manufacturing. The white paper includes a brief discussion around modern vacci…
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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…
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Selecting the Right Viral Clearance Technology
Ideally, methods from the first category, which include inactivation mechanisms such as low pH, detergent, or temperature hold steps and robust removal steps, such as virus filtration that clear a bro…
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Application of Quality by Design to Viral Safety
A quality-by-design approach defines a range of potential viral contaminants of source materials and can be used to effectively achieve viral clearance.
Oct 1, 2014
BioPharm International
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Selecting a Comprehensive Bioburden Reduction Plan
Process maps and risk assessments are among the valuable tools operators can apply to reduce the risk of microbial contamination.
By Randi Hernandez
There are multiple variables to consider …