Our DNA Vaccine Advantage
Proven Expertise in DNA Vaccine Development and Commercialization
DNA vaccine technology has historically seen limited commercial use due to a combination of the following factors:
- Very few experienced scientists have worked with this technology
- Regulatory pathway was unclear
- Unproven technology
The first successful commercialization of a DNA vaccine happened in 2016 at Elanco (CLYNAV™) and the Pegasus founders were leaders of the development team.
The COVID-19 pandemic has resulted in the need for new vaccine innovation including the use of DNA vaccines.
Pegasus has worked with clients to provide critical services and support for DNA vaccine development and commercialization. While our clients are scientific experts at their technology, they often lack experience in analytical & process development, GMP manufacturing and the DNA vaccine regulatory submission strategy which Pegasus has been able to provide them.
Current Service Offerings
- Seed/Plasmid Generation to Formulation Process Development
- Analytical Development Services including ELISA, HPLC, QPCR and others
- Lab-scale production of biomolecules (non-GMP)
- Consulting services for DNA vaccine development and production, biomolecule process and analytical development
Examples of Recent Pegasus Work on DNA Vaccines
- Development and tech transfer of manufacturing processes for producing DNA vaccines (Fermentation, lysis, TFF, column purification).
- Development and validation of multiple analytical methods for DNA vaccines, including HPLC analysis for plasmid homogeneity and API quantification, QPCR analysis of contaminating genomic DNA and other required tests for product release.
- Dossier preparation (CMC section)
- Consultation on DNA vaccine development including:
- Developing process and analytical development strategies to ensure cost-effective, compliant production.
- Assessing proposals from CMO’s.
- Providing guidance on the concept of quality by design (QbD) and how it applies to human vaccines.
- Developing ICH compliant assay validation protocol
Examples of Recent Pegasus Work on Other Development Projects
- Development and validation of potency ELISA’s to quantify the antigen in oil-adjuvanted bacterial animal health vaccines.
- Development and scale-up of the purification of an animal health biotherapeutic.
- Analytical development (HPLC) for an animal health biotherapeutic.
- Consultation on the development of a cell culture process used for the production of lab-grown, synthetic meat.
- Fermentation and analytical lab support as well as consultation on the fermentation, purification and analysis (QPCR) procedures of an animal health biotherapeutic.