Preclinical testing is a critical stage in vaccine development, where candidate antigens are first evaluated for expression, safety, and immune response in animal models. However, traditional methods like molecular cloning and plasmid production are often too slow to meet the urgent timelines of modern vaccine programs, especially during outbreaks. Delays in preparing gene constructs, verifying sequences, and scaling delivery materials can significantly slow down the pace of innovation and response.
Synthetic DNA technology offers a faster, more flexible alternative. By enabling the direct synthesis of expression-ready constructs—optimized for various hosts and experimental needs—researchers can quickly move into testing without lengthy cloning steps. This article explores how synthetic constructs are accelerating preclinical vaccine development, from rapid gene delivery and multi-species testing to high-throughput candidate evaluation and GMP-scale preparation. With these tools, vaccine teams can work faster, test more broadly, and bring better candidates to clinical trials with greater efficiency.
In vaccine development, time is often the most critical factor—especially during outbreaks. The preclinical stage, where vaccine candidates are designed, tested in the lab, and evaluated in animal models, plays a key role in determining how quickly a vaccine can move into human trials. Delays at this early stage can slow the entire process, costing lives and allowing diseases to spread. That's why researchers and companies are turning to faster, more flexible tools like synthetic DNA and automated production systems. These technologies help scientists respond quickly, design better vaccine components, and scale up materials efficiently when every day counts.
When a new virus emerges—like SARS-CoV-2, Ebola, or Zika—there's enormous pressure to act fast. Public health officials want vaccines ready in months, not years. But traditional methods of vaccine development can't keep up. In many cases, designing the right antigen, cloning it into a vector, making test batches, and checking them in animal models can take several months on its own. That's before even entering clinical trials.
For example, during the COVID-19 pandemic, researchers had the genome of the virus within weeks, but turning that information into a working vaccine still required preclinical testing of different antigen designs. This stage had to be done as quickly as possible, while still ensuring the candidate was safe, immunogenic, and manufacturable. Synthetic DNA helped speed this process dramatically. Instead of cloning genes from viral RNA and going through multiple rounds of PCR, scientists could simply order a custom DNA sequence designed to match their antigen of interest. Within days, they could begin producing proteins, testing immune responses, and preparing for animal studies. Synthetic platforms also made it easy to test multiple antigen variants in parallel, improving the chances of finding the most effective design on the first try. In outbreak response, every day saved in preclinical work can make a major difference. It allows for earlier clinical testing, faster manufacturing decisions, and quicker deployment of vaccines to people who need them most.
Speed is not only important in designing vaccine antigens—it also matters when producing the delivery systems used to carry those antigens into cells. Many modern vaccines rely on gene delivery platforms like lipid nanoparticles (LNPs), viral vectors (such as AAV or adenovirus), or plasmid DNA. Once a promising vaccine construct is identified, researchers must quickly make enough of these materials to support animal testing and later, clinical manufacturing.
Scaling up gene delivery components is often a bottleneck. Traditional plasmid production, for example, involves bacterial fermentation and purification steps that can take weeks. Producing viral vectors requires precise control of cell lines and transfection systems, which also take time to optimize. Synthetic DNA provides a way around some of these slow steps. For example, linear DNA or minicircle DNA can be produced in cell-free systems without relying on bacteria, which reduces turnaround time. Some companies are now developing enzymatic synthesis and cell-free assembly of DNA vectors, which allows rapid production of test-ready material without long culture processes. In addition, having pre-designed libraries of delivery materials and expression systems makes it easier to test combinations quickly. Scientists can mix and match different promoters, enhancers, or vector backbones to see which gives the best expression and immune response in early tests. With synthetic DNA, these changes can be made digitally and delivered in just days—enabling a level of speed and flexibility that's hard to match with traditional cloning.
Fast scale-up is especially important when a vaccine shows promise and needs to be moved into large-scale animal studies or Phase 1 trials. Having delivery materials ready at the right quality and quantity ensures there are no delays in this critical transition.
In the fast-moving world of vaccine research and development, especially during the preclinical phase, synthetic DNA has become a powerful tool. It offers scientists speed, accuracy, and flexibility—helping them design, build, and test vaccine candidates without the delays that come with traditional cloning. From enabling quick expression of proteins to supporting a wide range of animal models, synthetic DNA simplifies and accelerates early-stage vaccine work. It also ensures high-quality results with built-in quality control, allowing researchers to focus on testing immune responses rather than troubleshooting DNA issues. In the following section, we explore how synthetic DNA supports each part of the preclinical process.
One of the biggest advantages of synthetic DNA is that it allows researchers to go straight from sequence design to protein expression. In traditional methods, scientists first need to clone the antigen gene into a plasmid, insert it into a bacterial host, grow colonies, purify plasmid DNA, and then verify the sequence before any testing can begin. This process can take weeks—even longer if problems arise.
With synthetic DNA, scientists can simply design the gene of interest on a computer and order it as a ready-to-use, expression-optimized construct. These DNA fragments can be delivered in plasmid form, linear format, or as specialized expression cassettes designed for direct transfection into mammalian cells. Because the sequences are already optimized (e.g., for codon usage and mRNA stability), the antigens are more likely to express well right away. This approach saves valuable time. Researchers can quickly produce antigen proteins in cell culture, run ELISAs, conduct immunogenicity studies, or test antibody responses. Multiple variants can be tested in parallel without repeating the long cloning process for each one. For example, in a matter of days, a lab can compare five or ten different spike protein designs for a coronavirus vaccine and choose the best candidate based on expression level and immune recognition. In short, direct-to-expression synthetic DNA helps labs move from idea to data faster than ever.
Preclinical testing doesn't stop at the lab bench—it also requires testing vaccine candidates in animal models, such as mice, rabbits, or non-human primates (NHPs). Each species has different immune system features and may require different genetic elements to ensure proper antigen expression.
Synthetic DNA makes it easy to tailor constructs for each model. For example, a construct designed for use in mice might include a mouse-specific promoter, while the same antigen for an NHP study might use a human promoter or a broadly active viral element like CMV. The antigen itself might also need slight changes to improve folding or presentation in the specific host.
Because synthetic DNA is custom-designed, these adjustments are simple and fast to make. There's no need to modify an existing plasmid using multiple cloning steps—instead, scientists can order multiple species-specific versions at the same time. This flexibility is especially helpful when different regulatory agencies or collaborators require results in more than one model. Additionally, synthetic DNA can be adapted for use with various delivery systems in animals, such as DNA vaccination, electroporation, lipid nanoparticles, or viral vector platforms. This makes it a versatile tool that integrates easily into a wide range of experimental setups.
Another major benefit of synthetic DNA is that it removes many of the risks and errors associated with traditional cloning. When cloning by hand, even small mistakes—such as frame shifts, unwanted mutations, or insertions/deletions—can ruin an experiment and cause significant delays. Verifying every clone by sequencing and testing adds time, cost, and uncertainty.
In contrast, synthetic DNA providers deliver fully verified sequences that match exactly what was ordered. These constructs go through quality control (QC) processes such as full-length sequencing, purity checks, and concentration measurements. This means researchers receive DNA that's ready for transfection, vaccination, or delivery without needing to check or troubleshoot it themselves. Many synthetic DNA products are even delivered in formats designed specifically for gene expression—free of bacterial elements or antibiotic resistance markers—so they can be used directly in sensitive applications or regulated settings. Some platforms also offer endotoxin-free DNA for use in animal studies, reducing the risk of immune interference or false results. Because synthetic DNA arrives cloning-free, QC-verified, and expression-ready, it significantly reduces lab workload, technical errors, and experimental variation. This reliability is essential for running consistent preclinical tests and comparing data across different candidates, species, or delivery platforms.
At the preclinical stage of vaccine development, speed, flexibility, and reliability are key. Researchers need to evaluate multiple antigen designs, test delivery platforms, and prepare high-quality DNA for animal studies—all under tight timelines. Our synthetic DNA services are specifically designed to support vaccine R&D teams through every phase of this process. From rapid plasmid preparation to expert handling of complex sequences and high-throughput synthesis for parallel testing, we offer end-to-end solutions that streamline your workflow and accelerate progress toward clinical trials.
We provide comprehensive plasmid DNA preparation services at both research and GMP-grade levels to match your evolving development needs. For early-stage discovery, we offer research-grade plasmids with customizable scales—from small-prep yields for initial screening to mid-scale quantities suitable for protein expression and immunogenicity testing. These plasmids are delivered with QC data, sequence verification, and optional endotoxin-free preparations to support sensitive cell-based assays.
As your project progresses toward animal studies or regulated development, we provide GMP-compliant plasmid manufacturing, including full documentation, sterility testing, and adherence to global regulatory guidelines. Our GMP plasmids are suitable for direct use in DNA vaccine formulations or for viral vector production, helping ensure a smooth handoff to downstream processes. Whether you need milligram or gram-scale production, we offer scalable manufacturing that meets your program's timelines and regulatory expectations. We also support seamless transfer from research-grade to GMP-grade manufacturing using the same vector backbone, which reduces re-validation work and shortens your development cycle.
Many of today's most important vaccine targets—such as HIV envelope proteins, malaria surface antigens, and bacterial toxins—contain sequence elements that are difficult to synthesize, clone, or express. These include regions with high GC content, tandem repeats, internal palindromes, and unstable secondary structures. Our platform is optimized for robust handling of complex or unstable sequences. We apply a combination of:
We also offer structural redesign services that preserve antigenic regions while improving expression or stability—ideal for proteins prone to misfolding or aggregation. This enables your team to rapidly evaluate antigens that would otherwise require extensive troubleshooting or iterative redesign. By outsourcing these challenging tasks to us, you save critical time and resources while ensuring construct fidelity and reproducibility.
Evaluating multiple antigen candidates in parallel is key to efficient preclinical vaccine development. Whether you're screening variants of a spike protein, mapping dominant epitopes, or testing different vector formats, we support batch synthesis of dozens—even hundreds—of constructs at once.
Our high-throughput platform enables you to:
Each construct undergoes the same QC standards, including full-length Sanger or NGS verification, purity checks, and optional endotoxin removal. We also offer modular vector assembly, enabling rapid reformatting into expression, delivery, or reporter vectors. This batch synthesis capability helps your team make side-by-side comparisons of antigen designs—speeding up candidate selection, minimizing variability, and reducing iteration cycles. It's especially valuable for teams pursuing rational antigen design or variant-based vaccine development.
DNA synthesis services at BOC Sciences