The vaccines against SARS-CoV-2 were a powerful demonstration of the speed at which safe and efficacious mRNA vaccines can be produced. Outside of an emergency, however, each prophylactic vaccine candidate follows a traditional, multi-year workflow.
Rapid access to high-quality DNA templates is essential as they are the starting material for mRNA production. Delays in obtaining DNA directly delay development, which is critical during a pandemic or other medical emergency. Learn how ENFINIA IVT Ready DNA keeps the process moving.
STEP ONE
DAYS ⇒ WEEKS
Target Identification
The development of mRNA prophylactic vaccines begins with the identification of a disease-relevant protein. In the case of a prophylactic mRNA vaccine, the target will be a viral or bacterial antigen.
STEP TWO
DAYS ⇒ 1 MONTH
Target Antigen Encoded in mRNA
Prophylactic vaccines require screening of 100s of mRNA variants to find a single, optimal construct for all patients. This includes testing different codons, UTRs, and poly(A) tails to ensure the best expression and immune response before preclinical development.
How Elegen Helps
The speed of generating DNA templates that encode mRNA variants is critical to the rapid screening, selection and optimization of candidates. Conventional plasmid methods are slow and can cause bottlenecks that delay development. ENFINIA IVT Ready DNA eliminates plasmid cloning, accelerating the process and enabling faster decision-making.
STEP THREE
1 ⇒ 4 YEARS
Preclinical Studies
Optimized mRNA candidates advance to preclinical studies to demonstrate proof of concept, safety, and feasibility—the foundation of an IND submission. This stage requires scale-up and stricter quality standards to support animal studies, characterization, and CMC development.
How Elegen Helps
To accelerate these efforts, ENFINIA IVT Ready DNA templates can be produced at higher microgram yields without using cells or the contamination risks they introduce.
STEP FOUR
5 ⇒ 8 YEARS
Clinical Trials
Clinical studies for prophylactic vaccines establish safety, dosing, and efficacy in humans. To meet the needs of large-scale trials, manufacturing must be scaled up to the gram range with GMP standards.
How Elegen Helps
Elegen partners with leading cGMP RNA manufacturers to rapidly scale clinical production using ENFINIA IVT Ready DNA templates.
STEP FIVE
YEARS
Commercialization
Once approved, mRNA vaccines are manufactured at a consistent quality for patient use. For prophylactic vaccines, a single DNA template is manufactured at a large scale to produce identical mRNA for a global population.
How Elegen Helps
ENFINIA IVT Ready DNA templates scale seamlessly with GMP partners to support large-scale production needs.
Prophylactic vaccine development requires obtaining DNA templates quickly– putting significant pressure on the speed and quality of DNA synthesis. Unfortunately, DNA Synthesis suppliers that rely on plasmids and cell-based cloning often become a bottleneck.
At Elegen, we’ve broken this bottleneck, delivering long, complex, NGS-verified DNA in a matter of days, eliminating the cloning delays, sequence rejections, and synthesis limitations that often slow down construct design and testing.
Whether you’re developing prophylactic vaccines or other mRNA therapeutics, Elegen enables faster iteration, broader construct screening, and greater reliability, helping researchers make go/no-go decisions earlier and reduce time-to-clinic.
Linear fragments up to 5.5 kb, shipped as fast as 10 business days
No endotoxin risk; no linearization or purification required
Reaction-ready format for faster in vitro transcription and testing
Rapidly test diverse sequence complexities and poly(A) tail designs (including segmented formats)
Built using Elegen’s patented cell-free DNA manufacturing technology
NGS-verified, high-fidelity constructs
