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?
Four of these large, enveloped, positive-strand RNA viruses are endemic globally and thought to cause 10–30% of upper respiratory tract infections in adults (1). They possess a surface spike (S) glyco…
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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
At least 110 VLPs have been constructed so far from 30 different virus families (1), and a variety of expression systems ranging from bacteria to mammalian cell systems have been used for their produc…
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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
These procedures are effective for most agents, but some organisms, particularly viruses and prions, have evaded standard prevention and testing methods. New technologies in biosafety testing target t…
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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…