Search results for " host cell"
Article
Application of Quality by Design to Viral Safety
Each unit operation is likely to contribute to or impact other CQAs like host cell protein removal for chromatographic steps, for example. Therefore, the definition of an acceptable design space for e…
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Scalable Viral Vector Manufacturing
Viruses are produced by cell culture and the host cell line must be well characterized and the culture conditions has to be thoroughly optimized. Also, the cell culture medium and any supplements need…
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QbD Improves Cell-Culture Process Control
Mammalian cells are most frequently used as the hosts for manufacturing complex biopharmaceuticals, and cultivation of these host cells is a key factor in the production of biotherapeutics. The cultiv…
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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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Reimagining Affordable Biosimilars
Cost of biosimilar development
Development of biosimilars begins with cloning the appropriate host cells with the target gene. This is a multistep process involving upstream processes (e.g.,…
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Managing Residual Impurities During Downstream Processing
Some specifics on residual HCPs
The presence of HCPs in a biologic material is inevitable given that the main route of production for biopharmaceuticals is through recombinant technology via a host…
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Eliminating Residual Impurities Starts with a Strategic Plan
They can be derived from the host cell or the product itself, media components, surfactants, virus inactivation agents, inorganic or organic contaminants from permanent and single-use process equipmen…
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Flexible Facilities for Viral Vector Manufacturing
Single-use and modular systems will meet demand for rapid implementation at different scales.
By Jennifer Markarian
Industry experts have noted that there are limitations in the…
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Re-use of Protein A Resin: Fouling and Economics
Specificity of Protein A ligand towards mAb results in extremely effective clearance of host cell proteins (HCP), viruses, and DNA (2–5). The high selectivity is accompanied by reasonably good physioc…
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Evolution of the Monoclonal Antibody Purification Platform
Typical steps include:
• Protein A chromatography for capture of the product and removal of host cell-related impurities (host cell proteins and DNA). Though extremely efficient and effective,…