Search results for "viral safety"
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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Other raw materials used in the manufacture of biotherapeutics, especially those of animal and human origin, could also present a viral safety risk.
Traditionally, the management of inadvertent vi…
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Application of Quality by Design to Viral Safety
The viral safety of a product is an important CQA, and the following is an overview of how QbD can be applied to both the selection and testing of raw materials for adventitious viruses as well as the…
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Ensuring Viral Safety of Viral Vaccines and Vectors
This article outlines the risks and challenges associated with managing viral safety in virus vaccines and vectors for gene therapy, and highlights a holistic risk-mitigation approach of testing and c…
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Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
Advances in cell culture media technology have helped achieve safer biologics.
By Tom Fletcher, Holden Harris
Regulatory expectations for cell-culture-based biologics production processes ch…
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Filtration methods to overcome new challenges in viral safety
Read our article which summarizes the recent virus filtration regulatory changes in PDA Technical Report No. 41 and ICH Q5A, and outlines the detailed mechanisms governing effective virus filt…
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Updating Viral Clearance for New Biologic Modalities
“In addition, processing may be temporarily paused during runs, and it is critically important that these temporary depressurization events do not compromise viral safety,” he says.
Next-gen bioph…
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Gene Therapies Push Viral Vector Production
Gene Therapies Push Viral Vector Production
Viral vectors show promise as a delivery mechanism for gene therapy, but which virus types are commercially viable?
By Feliza Miraso…
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Putting Viral Clearance Capabilities to the Test
Bergmann, manager, viral safety and clearance services, Eurofins Lancaster Laboratories. “The key parameters that determine the scope of the study are the clinical stage and indication of the product …
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Selecting the Right Viral Clearance Technology
Remington believes that this increased understanding will facilitate the design of processes that optimize viral safety. Taking a holistic approach is the most effective means of achieving viral contr…
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Viral Clearance Challenges in Bioprocessing
Guidance on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin (1998).
2. Parenteral Drug Association, Technical Report No. 47: Preparation of Virus…