A well-developed, broadly reactive, and qualified HCP ELISA remains a gold standard method effectively used during the purification process to ensure removal of HCP and to demonstrate process consistency and final drug substance purity. Regulatory guidelines require that sponsors use orthogonal methods for demonstrating antibody coverage to individual HCPs and provide a comprehensive assay qualification package to ensure the HCP ELISA is fit for purpose.
In this presentation, we will discuss the best practices in HCP immunoassay qualification and bridging necessitated with certain critical reagent changes that might occur due to one or more critical reagent depletions.
A case study using two CHO HCP antibodies and advanced orthogonal Antibody Affinity Extraction (AAE™) and MS methods for antibody and assay qualification will be presented.
- Steps to qualify HCP ELISA.
- Types of reagent changes.
- Advanced orthogonal methods for anti-HCP antibody characterization and bridging.
Just fill out the form below to watch the recorded webcast now.