Working with its partner, Waisman Biomanufacturing, researchers at WHV created dedicated lots of vialed individual DNAs from its DNA vaccine to be used as reference standards in the future.
Reference standards of clinical-grade vaccine allow cross-comparison between products from different manufacturing campaigns. With their well-defined characteristics, they help ensure that the vaccine produced for a clinical trial or for commercial distribution is equivalent to the vaccine used previously to establish safety and immunogenicity.
The advances in DNA manufacturing accomplished by WHV and Waisman in their latest plasmid production resulted in substantial improvements in yield and purity of PDPHV DNA vaccine. After generating sufficient DNA final product to support its planned Phase 2a clinical trial, WHV used the remaining material to generate reference standards.
The investment in reference standards highlights WHV’s commitment to the long-term development of its PDPHV vaccine candidate. These standards will be useful in the next manufacturing campaign that will be needed to provide vaccine for the large efficacy trial, and can even be used in the future to support the licensed vaccine manufacturing.
