Next-Gen Gene Synthesis using Cell-Free Cloning to speed up therapeutic development

Vaccines Are Gene Therapy Injections?

Advancing mRNA Vaccine and Therapy Development

The COVID-19 pandemic and the development of its mRNA-based vaccines brought attention to the need for faster healthcare innovations to meet medical challenges. To stay competitive, biopharmaceutical firms must adopt innovations like "Next-Gen Gene Synthesis using Cell-Free Cloning to speed up therapeutic development"

Advancing mRNA Vaccine and Therapy Development

Next-Gen Gene Synthesis with Cell-Free Cloning

July 18, 2024

Elegen July 2024 coverThe COVID-19 pandemic and the development of mRNA-based vaccines brought attention to­ the need for faster healthcare innovations to meet medical challenges. Since those first FDA approvals, companies have raced to apply this technology to prevent and treat many illnesses,­ including influenza, diabetes, HIV and various cancers.

One ubiquitous and indispensable biomanufacturing input ripe for improvement is a scalable, turnkey solution for high-quality synthetic DNA. DNA serves as the programmatic code for every living cell and plays a crucial role in developing all biopharmaceuticals, including mRNA vaccines.

Surprisingly, conventional DNA synthesis has seen little innovation. It relies on a slow, continuous build process to transform low-quality oligonucleotides and fragments into longer DNA through cloning. In the early stages of biopharmaceutical development, the iterative design-build-testlearn (DBTL) cycle is crucial. This cycle involves repeated testing and redesigning of synthetic DNA constructs to identify potential therapies. However, traditional methods often take weeks, especially for complex DNA constructs, delaying the optimization of candidate therapies and significantly slowing progress.

To stay competitive, biopharmaceutical firms must adopt innovations like Next-Gen Gene Synthesis using Cell-Free Cloning to speed up therapeutic development. Elegen’s innovative cell-free synthesis platform produces ENFINIA™ DNA, which is sequence-perfect, double-stranded linear DNA up to 7,000 bp, shipped in a week. This high-quality, high-complexity, NGS-verified DNA requires minimal cloning and is ready for immediate use in therapeutic workflows. With accuracy nearly equivalent to clonal DNA, ENFINIA DNA significantly reduces the weeks typically needed for cloning, purification, and linearization of plasmid DNA for IVT workflows.

This innovation in DNA manufacturing offers unparalleled scalability and cost-efficiency compared to traditional methods, revolutionizing the discovery and development of mRNA therapies to enable rapid scale-up of therapeutic candidates for preclinical and clinical studies. By eliminating bottlenecks in genetic medicine workflows, this technology not only accelerates the development process but also ensures the delivery of full-length, high-quality DNA free from cellular contaminants. Looking beyond mRNA biotherapies, this capability is particularly crucial for individualized therapy, where the accelerated production of safe and effective treatments, devoid of cellular contaminants, can significantly impact patients’ time-to-treatment options.

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Me: Next-Gen Gene Synthesis using Cell-Free Cloning to speed up therapeutic development

Gene Therapy Injections?