Starting with a small quantity of plasmid DNA containing the desired sequence, the process uses a high-fidelity DNA polymerase enzyme to generate continuous chains of the required DNA sequence interspaced with sites which are specifically recognised by an enzyme called protelomerase. The protelomerase cuts the chains and then re-joins the desired DNA, now known as doggybone DNA, into discrete linear segments which are resistant to degradation during subsequent purification steps.
dbDNA can be made to good manufacturing practice (GMP) grade which allows it to be utilised in clinical applications such as gene therapy and vaccine manufacturing. The efficiency of the process has enabled Touchlight to build the world’s highest-capacity DNA manufacturing facility to make GMP grade DNA.
By working with regulatory authorities who recognised the process could be applied to multiple DNAbased future medicines, a Drug Master File has been accepted by the United States Food and Drug Administration (FDA). This can be used by medicine manufacturers for facilitating more rapid regulatory submissions for therapies made using the process.
The rapidity of the process enables novel interventions for response to diseases such as cancer, where whole genome sequencing can identify patient-specific mutations, and then rapid DNA synthesis can provide personalised cancer vaccine medicine in a realistic timeframe. In the future, rapid DNA production will have a positive impact on wider society as it enables a quick vaccine response to a pandemic.