DNA Vaccine Development

DNA Vaccine DevelopmentDNA vaccines are relatively easy to produce, stable and safe. This type of vaccine uses genetic material (DNA) from a disease-causing virus or bacterium (a pathogen) to stimulate an immune response against it.

The vaccine is comprised of 2 parts:

  1. A piece of DNA encoding instructions for making a specific protein (or part of a protein) from the pathogen, which the immune system will recognise as foreign (called an antigen).
  2. A circular piece of DNA used by bacteria to store and share genes (a plasmid). Once inserted into host cells, this genetic material is read by the cell’s own protein-making machinery and used to manufacture antigens, which then trigger an immune response.

Vaccines containing DNA plasmids carrying the antigen are usually injected into the muscle, but a key challenge for DNA vaccines is getting them to cross into the vaccinated host’s cells to enable them to access the machinery which enable the antigen to be translated into protein. Various technologies are being developed to aid this process, but one proven technology used to accomplish this is encapsulating the DNA in nanoparticles which are designed to fuse with the cell membrane.

The first successful commercialization of a DNA vaccine happened in 2016 at Elanco (CLYNAV™) and the Pegasus founders were leaders of the development team.
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.

DNA vaccines are relatively easy to manufacture. Once DNA encoding the antigen has been chemically synthesised, it is inserted into a bacterial plasmid with the help of specific enzymes - a relatively straightforward procedure. Multiple copies of the plasmid are then produced at high scale within rapidly dividing bacteria, before being isolated, purified and encapsulated into nanoparticles. Optimization of each part of this process is very important to produce the highest yields and quality of vaccine at the lowest cost.

Pegasus offers several services for our clients interested in DNA vaccine development. This includes expert and experienced advice on all stages of development from concept to final product. We provide plasmid design and selection as well as fermentation development, formulation development, stability analysis, vaccine safety and efficacy, and final product formulation.

Offered Services

  • Seed/Plasmid generation
  • Fermentation development utilizing powerful statistical tools such as DOE (Design of Experiments)
  • Formulation development
    • Formulation design
    • Stability testing
    • Sterility testing
  • Development and tech transfer of manufacturing processes (Fermentation, lysis, purification).
  • Development and validation of analytical assays, including HPLC analysis for plasmid homogeneity and API quantification, QPCR analysis of contaminating genomic DNA and other required product release tests.
  • Dossier preparation (CMC section)
  • Consultation on DNA vaccine development including:
    • Process and analytical development strategies to ensure cost-effective and regulatory compliant production.
    • Assessing proposals from CMO’s.
    • Providing guidance on the concept of quality by design (QbD) and how it applies to DNA vaccines.
    • Developing ICH compliant assay validation protocol(s)
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