Residual Nucleic Acid Characterization of Cell Culture-Produced Vaccines and Biologics

Determination of residual host cell DNA and RNA are regulatory expectations as they pose potential safety concerns for cell culture-derived vaccines and other biologics. In addition to the quantity of residual DNA or RNA, the size distribution of residual DNA fragments is an important factor related to the oncogenicity and potential for infectivity. Due to the low amount of residual fragments present, developing an assay for with high sensitivity, specificity, and resolution can be a great challenge.

 

Join Peter Holper from SCIEX to discover a new approach to finding a robust, sensitive sizing method for residual nucleic acid analysis.

 

Learning Objectives