Search results for "aggregates " in Articles / App Notes
Article
Detecting Protein Aggregates and Evaluating their Immunogenicity
Brown notes there does not seem to be a consensus yet in whether the presence of submicron (
Article
Challenges of Protein Aggregation During Purification
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Removal of protein aggregates from biologic APIs is crucial due to their potential to increase immunogenicity. While most aggregates are formed during upstream operations, and the risk for …
Article
Predicting Progress in Protein Aggregation
“There is evidence to suggest that the presence of aggregates increases the immunogenicity of biologic drugs. How aggregates trigger immune responses, and which aggregates are responsible, isn’t known…
Article
Developing a HIC polishing step for removal of mAb aggregates
This article describes the development of a flow-through (FT) polishing step using hydrophobic interaction chromatography (HIC) to remove mAb aggregates.
It includes:
- The use of HTPD plate…
Article
What If You Could Remove Your Antibody Aggregates Already in the Protein A Step?
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In this study, the potential of Protein A chromatography to separate antibody monomer from HMW species was investigated. A design of experiments approach…
Article
Modeling the Degradation of mAb Therapeutics
Modeling the Degradation of mAb Therapeutics
Kinetic models can be used to study aggregation and fragmentation to help ensure stability.
By Anurag S. Rathore, Rohit Bansal
…
Article
Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
Soluble aggregates and subvisible particle counts were measured by size-exclusion chromatography and micro-flow imaging, respectively. Thermal analysis of protein samples was performed by modulated di…
Article
Preclinical Evaluation of Product Related Impurities and Variants
From the processing perspective, while clearance of aggregates and the reduced GCSF impurity are quite achievable in most commercial processes, adequate clearance of the oxidized and f-Met GCSF is a c…
Article
Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification
Selectivity between mAb monomer and aggregates was also studied using DoE, analyzing factors such as pH and NaCl concentration. For this purpose, small-scale columns were employed. Aggregate concentra…
Article
Top Tips for Successful Development of Antibody Chromatography Processes
Then, he shares his top tips for addressing challenges associated with mAb aggregates removal and separation of homo and heterodimers.
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