Search results for "virus" in Articles / App Notes
Article
Ensuring Viral Safety of Viral Vaccines and Vectors
Viral vaccines rely on antigenic properties of a virus or virus-like particle (VLP) to trigger an immune response against an incipient viral infection. Because of the risks associated with live and in…
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Putting Viral Clearance Capabilities to the Test
The studies must be designed to evaluate potential viruses, be representative of the production process, meet regulatory requirements, and provide reportable data. In addition, the testing should be c…
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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
…dies, is associated with the concomitant risk of process/product contamination with endogenous retroviruses, latent viruses, or new and emerging adventitious agents. Cell-culture applications are imp…
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Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
Following the 2009 outbreak of the H1N1 pandemic flu and the numerous delays in producing vaccines against the virus, the US Department of Health and Human Services (HHS) recognized the need to invest…
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Genetic Vaccine Platforms Demonstrate Their Potential
Viral vaccines specifically can be classified into ‘classic or traditional vaccines’ and include attenuated/killed virus. Recombinant vaccines include subunit, virus-like particle (VLP), conjugate, an…
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Updating Viral Clearance for New Biologic Modalities
Because viruses are typically smaller than downstream impurities such as host cell proteins (HCPs) and other extracellular debris, they require meticulous filtration, even in more established processe…
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Selecting the Right Viral Clearance Technology
The success of viral clearance depends on the selection of appropriate methods that ensure the removal or destruction of any viruses without affecting the target protein. Several factors must be consi…
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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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Can Vaccine Development Be Safely Accelerated?
That changed with the advent of severe acute respiratory syndrome coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV) in the past decade. The latest coronavirus─2019-n…
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Gene Therapies Push Viral Vector Production
By Feliza Mirasol
Several virus types have been studied for use as viral vectors in gene therapy, including adenovirus, lentivirus, retrovirus, and adeno-associated virus (AAV). Of these, AA…