Search results for " aggregation"
Article
Detecting Protein Aggregates and Evaluating their Immunogenicity
Protein aggregation can occur during all stages of the lifetime of a protein therapeutic, including expression, refolding, purification, sterilization, shipping, storage, and delivery processes (1). T…
Article
Challenges of Protein Aggregation During Purification
…increased as titers have increased, if unsuitable conditions are selected for downstream operations, aggregation can also occur during downstream processing.
Aggregation mechanisms
There are …
Article
Predicting Progress in Protein Aggregation
As the development of biologic drugs based on antibodies and other protein/peptide molecules continues apace, the control and prevention of aggregation during manufacturing, downstream processing, for…
Article
Developing a HIC polishing step for removal of mAb aggregates
…conditions
- A Monte Carlo simulation to identify the robust conditions to reach the objectives in aggregation removal and the monomer recovery.
Read the full article now
Article
What If You Could Remove Your Antibody Aggregates Already in the Protein A Step?
Register for this free, online webinar >>
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
Both physical effects such as aggregation and chemical modifications (e.g., fragmentation) are the two leading paths for mAb degradation. Kinetic modeling can be an effective tool for establishing pro…
Article
Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
Nesta
Abstract
The objective of this study was to assess the impact of manufacturing-scale, freeze-thaw conditions on aggregation and subvisible particle formation of a monoclonal antibody sol…
Article
Preclinical Evaluation of Product Related Impurities and Variants
In addition, it has been reported that GCSF has a free cysteine residue (cys-17) that can trigger aggregate formation, and so post-manufacturing aggregation of GCSF is a possibility (13). Recombinant …
Article
Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification
Optimization of each phase in a chromatographic cycle has a positive impact on productivity.
By Anna Grönberg
An important area of focus for the biopharma industry is the elucidation and dev…