Better Biotherapeutic Characterization For Improved Quality Control

Critical quality attributes (CQA) are fundamental to regulatory compliance and typically include data on how the candidate interacts with target proteins, size, and purity. In addition, information on process related CQA such as protein integrity, homogeneity, presence of host cell proteins, and DNA is required. This poster booklet provides a snapshot on how different analytical technologies have been used to look into aspects related to the efficacy, stability, and safety of therapeutic candidates.

Highlights include:

• Quantitate aggregates and/or protein fragments
• Surrogate potency assays with SPR—two CQA determined in only one assay
• Facilitating IgG FcRn analyses
• Reliable HCP detection