Search results for " host cell protein"
Article
Innovative Chromatography Resins Can Improve Purity and Quality
He concluded that conventional multi-step DSP development bears the increased risk of commercial viability, where yield, impurity levels (such as host cell proteins or product-related impurities) or o…
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Process Chromatography Selection for Downstream Processing Applications
This technology can provide good host cell protein removal within a relatively broad operating window of pH and conductivity, since the binding of impurities is primarily due to van der Waals interact…
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Can Vaccine Development Be Safely Accelerated?
Can Vaccine Development Be Safely Accelerated?
Biopharma companies responding to the COVID-19 outbreak think accelerating the development of vaccines is safe.
By Cynthia A. Ch…
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Managing Residual Impurities During Downstream Processing
In acknowledgement of the importance of controlling HCP content, USP General Chapter “Residual Host Cell Protein Measurement in Biopharmaceuticals” was first published in the 2nd Supplement of the Un…
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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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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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Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
While the multiple attributes method gains ground and traditional lab methods improve, broad efforts are underway to determine biopharmaceuticals’ most significant critical quality attributes and en…
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Optimizing Late-Stage and Commercial Cell-Culture Processes
Optimizing Late-Stage and Commercial Cell-Culture Processes
Late-stage and commercial biomanufacturing pose a challenge to cell-culture processing.
By Feliza Mirasol
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Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Analytical exoglycosidases are transitioning from being largely academic tools to being s…
Article
Eliminating Residual Impurities Starts with a Strategic Plan
Eliminating Residual Impurities Starts with a Strategic Plan
Identifying the source, assessing the risk, and removing residual impurities requires a strategic approach.
By Cynthia A. Ch…