Search results for " aggregates"
Article
Detecting Protein Aggregates and Evaluating their Immunogenicity
Aggregation risk factors
Certain manufacturing stages influence the risk of chemical degradation, which increases the risk of physical degradation and the formation of aggregates. “These stages in…
Article
Challenges of Protein Aggregation During Purification
32-35
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…
Poster
Optimizing dynamic binding capacity and aggregate clearance in an mAb polishing step
Capto™ S ImpAct is a strong cation exchange (CIEX) chromatography medium (resin) designed for monoclonal antibody (MAb) polishing steps. In this study, optimization of binding conditions targeting h…
Article
Modeling the Degradation of mAb Therapeutics
According to this model, aggregation occurs in two steps: conformational reversible unfolding of the protein molecule followed by irreversible assembly into aggregates, which are either physically or …
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…