Search results for "virus"
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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…
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Scalable Viral Vector Manufacturing
The manufacturing processes and technologies are critical to enable cost-efficient and scalable production of safe and efficacious clinical-grade virus products. This week, Process Development Forum s…
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Virus-like Particles as Therapeutic Moieties of the Future
Rathore
Virus-like particles (VLPs) are viral capsid shells assembled without encapsulated nucleic acid. These particles resemble native virions, are highly ordered and repetitive, and are approxi…
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From Darwin to Recombinant Fc Multimers
In the session, Nathan Roth from CSL Behring Australia presented approaches towards Hepatitis E virus and Zika virus, two recent emerging pathogens, and studies confirming the effectiveness of existin…
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Ensuring the Biological Integrity of Raw Materials
(4) One affected vaccine was Rotarix, a rotavirus vaccine manufactured by GlaxoSmithKline. Porcine circovirus was detected in the vaccine, a discovery that led to a halt in the use of Rotarix, which i…
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Selecting a Comprehensive Bioburden Reduction Plan
For example, mammalian cell lines or formulation constituents may require routine monitoring for mycoplasma or viruses. Open process operations are more susceptible to contamination than are closed pr…