Regulatory bodies typically impose a limit on the acceptable degree of protein aggregation that a biotherapeutic may exhibit, and therefore the confirmation of protein aggregate levels is vital throughout the drug development and production process.
These resources describe rapid and reliable workflows for protein aggregation detection with solutions to improve productivity while giving you confidence in the ability to identify and separate higher order structures.
Protein aggregate analysis workflow
Aggregation screening requires a powerful and flexible UHPLC. To optimize your separation, the column selection is critical in this workflow. MAbPac SEC has a proprietary hydrophilic bonded layer that results in minimal non-desired interactions between the stationary phase and the biomolecules. Its nonmetallic and biocompatible PEEK housing eliminates metal contamination from the column.