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Optimizing Biologics Formulations

Quantifying Trace Subvisible Protein Aggregates Using a Protein Aggregation Assay and Standards

Aggregation represents one of the most significant obstacles to the development of protein-based pharmaceuticals. During drug formulation, protein aggregation can impact product quality in terms of biological activity and immunogenicity.

Protein aggregation can occur at all stages in the manufacturing process including cell culture, purification, formulation, storage, shipping, and handling. The pharmaceutical industry requires improved methods to detect, monitor, and quantify factors governing aggregation during manufacturing.

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