Using Residual DNA Quantification Data to De-risk mAb Development

IND submission is a critical milestone in mAb development — but analytical methods established at this stage must ultimately support validation, tech transfer, and evolving regulatory expectations. Among these, residual host cell DNA quantitation assays play a central role in monitoring residual impurity levels, supporting process performance, and may help reduce downstream risks.

This webinar will position residual DNA quantitation not as an isolated assay, but as a dataset that can be applied across downstream process intermediates to inform decision-making. Using data generated from protein-rich samples, we will explore how assay sensitivity, recovery, and reproducibility perform under realistic manufacturing conditions, including high IgG matrices.

Through practical examples, attendees will see how residual DNA measurements can be used to compare purification performance across unit operations, identify potential clearance risks early, and support development of scalable, validation-ready processes. The session will also highlight how sample composition and process conditions influence data interpretation, reinforcing the importance of designing assays that remain robust as workflows evolve.

Learning objectives:

~ Evaluate how residual host cell DNA quantitation can be used to assess impurity clearance across downstream mAb process steps
~ Interpret residual DNA data generated from complex, protein-rich matrices to support process decision-making
~ Identify key performance characteristics (e.g., sensitivity, recovery, reproducibility) required for validation-ready residual DNA assays
~ Apply strategies for designing residual DNA workflows that remain robust and scalable from development through manufacturing