10 November 2025 | Monday | Analysis
Vaccines remain the cornerstone of infectious disease control, but traditional development pathways are slow and resource‐intensive. Modern challenges – from emerging pandemics to personalised immunotherapies – demand integrated high‐throughput technologies across the vaccine pipeline. By combining massive parallel screening, laboratory automation, robotics and artificial intelligence (AI), researchers and manufacturers can compress timelines and improve product quality. High‐throughput genomic and proteomic tools now allow the rapid identification of antigens and immune signatures, while robotic platforms and AI analytics process and interpret this data. In the words of Sydney Brenner, “we are drowning in a sea of data and thirsting for knowledge”, yet advances in high‐throughput methods are beginning to turn raw data into actionable vaccine designs. This report examines how these technologies accelerate vaccine discovery, preclinical and clinical research, and manufacturing, with case studies and discussion of challenges and future prospects.
High‐throughput screening (HTS) traditionally refers to techniques that test thousands of biological samples or compounds in parallel. In vaccinology, HTS can rapidly evaluate candidate antigens, adjuvants or formulations using automated microplate and microarray systems. For example, peptide libraries or protein arrays can be screened against antibodies or immune cells to identify immunogenic epitopes. Advances in sequencing also play a role: today’s next‐generation sequencing (NGS) – a form of HTS – can enumerate T‐ and B‐cell receptor repertoires or pathogen genomes rapidly. As Pasik et al. note, HTS platforms and bioinformatics are “widely available, falling in cost, and results are achieved very quickly. They enable the construction of modern vaccines”. This includes reverse vaccinology, where pathogen genomes (sequenced in high throughput) are mined computationally for antigen candidates.
Laboratory automation and robotics underpin these high‐throughput screens. Automated liquid handling robots can set up and run hundreds of assays per day with precision and reproducibility. Robotic “cobots” and industrial arms can handle infectious materials safely, as seen in COVID‐19 efforts (see Case Study below). By replacing manual pipetting, robots increase throughput and remove human error. For example, one group reported using ABB robots to automate a virus neutralisation assay: collaborative robots mixed SARS‐CoV‐2 samples and antibodies, reducing staff risk and enabling repeated testing without fatigue. In Moderna’s R&D labs, robotic synthesis and AI allowed over 1,000 mRNA constructs per month to be made for screening – a 30‐fold increase in throughput. These platforms make the “design–make–test” cycle far more efficient.
AI and machine learning (ML) add another layer of acceleration by analysing and predicting outcomes from high‐throughput data. Traditional vaccine design relied on trial-and-error lab work, but now AI can guide those experiments. In silico epitope prediction algorithms scan pathogen proteins to identify the B‐ and T‐cell targets most likely to elicit immunity. For example, deep learning models (such as convolutional neural networks) have been used to classify epitopes and optimize multi‐epitope vaccine constructs. AI also integrates diverse data sources – from single‐cell RNA sequencing to structural models – to refine antigen selection. As one review observes, traditional vaccine development is “labour‐intensive” and can yield suboptimal formulations, whereas AI-driven approaches “streamline epitope selection by leveraging diverse datasets”.
Beyond design, AI assists in formulation and delivery. Generative models (e.g. GANs) can propose novel protein sequences or RNA constructs optimized for stability and immune activation. During COVID-19, Moderna used AI tools to rank mRNA sequences (optimizing untranslated regions and codon usage) rapidly. AI also expedites preclinical modelling; the U.S. FDA is exploring replacing some animal tests with computational models of immunogenicity. In short, AI turns the deluge of high‐throughput data into clearer decisions, greatly speeding vaccine candidate selection.
High‐throughput techniques revolutionise the search for vaccine targets. Modern sequencers can rapidly read entire pathogen genomes or strain variants, feeding bioinformatics pipelines. For emerging pathogens, this meant that SARS-CoV-2 was sequenced in days, enabling immediate vaccine design. Researchers can then apply in silico reverse vaccinology: scanning the sequence for proteins with desired features (surface exposure, conservation, antigenicity). Computational tools predict B‐cell and T‐cell epitopes; AI improves this by learning from known immune responses. For example, a transformer‐based model might identify spike protein regions most likely to generate neutralising antibodies.
Parallel to dry lab work, high‐throughput laboratory assays test many antigens and adjuvants. Automated ELISA arrays or multiplexed bead assays can measure antibody binding to dozens of candidate antigens. Flow cytometry has been miniaturised into high-content platforms for evaluating T‐cell responses. Even organ-on-chip devices and human cell culture arrays allow rapid immunogenicity screening at scale. These combined approaches – sequencing‐guided selection followed by robotic bench assays – compress antigen discovery from years to weeks.
Once candidates are chosen, high‐throughput tools profile immune responses in preclinical models. “Systems vaccinology” refers to large‐scale monitoring (transcriptomics, proteomics, metabolomics) of how cells and tissues react to a vaccine. For instance, RNAseq can measure gene expression in immune cells from vaccinated animals, revealing signatures that predict efficacy. High-throughput cytometry and single-cell sequencing dissect the diversity of immune cell activation. These data-driven approaches can identify correlates of protection or potential reactogenicity signals early.
Safety assessment also gains from automation. In vitro toxicology screens – using human cell lines or induced pluripotent stem cells – can run in high-throughput to flag cytotoxic formulations. AI models have been developed to predict adverse effects of immunogens and adjuvants based on historical data. By catching safety issues early (even before animal tests), developers can avoid costly failures. Moreover, regulators are encouraging alternative methods: as noted above, the NIH/FDA consider replacing some animal tests with validated computational models, provided the in silico tools are robust.
In clinical trials, high-throughput tools mostly aid monitoring and data management. For example, multiplex serology assays (Luminex or planar arrays) measure antibody breadth in hundreds of patient samples simultaneously. Flow cytometry cytometers can run multi‐parameter immune profiling for many participants. Genomic and proteomic analyses – essentially big data – track vaccine responses and identify biomarkers of efficacy or adverse reactions.
AI and data analytics play a growing role in trial design and analysis. Machine learning can stratify patient populations by predicted response, allowing adaptive trial designs or better patient matching. During the pandemic, digital symptom trackers and mobile health apps generated massive patient data; AI sifted these for safety signals and correlates of protection. While clinical trials are less “high‐throughput” in the screening sense, they benefit from the same computational and digital innovations that underpin discovery, making trials faster and more informative.
A key bottleneck is scaling up production of a lead candidate. Traditional stainless-steel fermenters are inflexible and slow to clean. In contrast, single-use bioreactors (SUBs) and modular systems have transformed vaccine manufacturing. Single-use systems (disposable plastic bags) eliminate lengthy cleaning and sterilisation between batches, greatly increasing turnaround. According to Lindskog et al., this disposables shift “offers increased flexibility with quicker set-up and changeover between runs, and reduces the need for costly and time-consuming cleaning and validation”. Most major vaccine plants now use single-use reactors up to 2000 L for cell culture or microbial fermentation.
For process development, high-throughput miniature bioreactors (e.g. Ambr® systems) allow many parallel runs. As one review notes, “small-scale, high-throughput, single-use bioreactors” let developers screen media, feeds and conditions before scaling out. Parameters optimised in these parallel mini-bioreactors can then be confirmed in larger stirred-tank SUBs. The uniformity of single-use systems across scales also mitigates surprises: if you run small and large cultures in the same type of reactor, scale-up tends to be more predictable. Thus, HT screening of culture conditions merges seamlessly into automated manufacturing platforms.
Modern manufacturing embraces real-time analytics to maintain quality. Process Analytical Technology (PAT) tools (sensors, spectroscopy, flow cytometry “virometry”) monitor critical attributes during production. For live viral vaccines, this is vital: classical potency assays (plaque or TCID50) take weeks, delaying decisions. New PAT tools – capacitance probes for cell density, flow-virometry for virus counts, high-content imaging – can predict vaccine potency in near-real-time. For example, a recent study describes Raman spectroscopy and virometry as surrogates to estimate virus antigenicity on-the-fly, enabling immediate process adjustments. As Yi et al. report, PAT “enables real time monitoring of [process parameters] on the shop floor and inform harvest decisions, predict peak potency, and serve as surrogates for release potency assays”. Such control strategies are crucial for rapid vaccine scale-up.
Looking further ahead, digital twins promise transformative impact. A digital twin is a computer model of the manufacturing process that runs in parallel with the real world. It ingests live sensor data (temperatures, flow rates, cell counts) and simulates the process, forecasting outcomes and optimisations. For instance, a digital twin of a bioreactor could predict when biomass will peak or if oxygen levels will drop, allowing automatic adjustments. As Manzano and Whitford explain, a DT “can run simulations that enhance process development and optimization. It can predict specified outcomes, flag required actions, and even support closed-loop process control”. In practice, this means near-autonomous production: the system monitors itself via IoT sensors, updates the virtual model, and uses AI to tweak conditions for maximum yield and quality. Such real-time integration of data and control (enabled by digital twins) is already being piloted in biopharma and will likely spread to vaccine production in the next few years.
Robotics are not only for discovery labs – they are increasingly used on the factory floor. The earlier case of Changchun Keygen in China is illustrative: this live-attenuated chickenpox vaccine plant automated nearly every step with robots. Twelve aseptic, six-axis robots now carry out cell culture passaging, virus inoculation, mixing and cleaning tasks in closed “cell factories”. The result is a fully robotic production line where humans are largely removed from aseptic operations. As one system integrator notes, “vaccine production automation involves a high degree of technological integration. It combines advanced technologies such as robotics, sensor technology, and control technology to achieve full automation from raw material processing to finished product. This makes vaccine production more efficient, precise and reliable”. In practice, robots can run 24/7 without fatigue, maintaining sterility and consistency. ABB’s YuMi and IRB robots (as described above) similarly proved in Thailand that automating repetitive virology assays accelerates development while protecting staff.
Other manufacturing tasks benefit from automation too: automated inoculation systems, robotic fill/finish machines, vision-guided vial handling and packaging. The result is a “lights-out” factory where connected equipment flows product through each stage with minimal manual intervention. Combined with single-use and PAT, this integrated approach substantially compresses the time from cell bank to commercial product.
The COVID-19 pandemic provided a stark example of accelerated vaccine development. Within weeks of the SARS-CoV-2 genome release, designers had mRNA vaccine candidates ready. Moderna, in particular, exemplified an “AI-augmented” pipeline. As Moderna’s Chief Data Officer described, their labs used high-throughput robotic synthesis and AI algorithms to scale mRNA design and testing. Where scientists once made a few dozen mRNA variants, Moderna’s system generated over 1,000 constructs per month. This automation let them rapidly iterate on 5’/3’ UTRs, codons and lipid nanoparticle formulations. Combined with years of prior mRNA platform development, this pipeline compressed a typical decade-long process into about 269 days. By relying on computational modelling and lab automation, these teams could analyse antibody and T-cell responses from early clinical samples in real time and tweak designs accordingly.
Mahidol University in Thailand set up an “AI-Immunizer” system to support COVID vaccine R&D. Two ABB robots – a dual-arm YuMi cobot and an IRB 1100 – automated plaque reduction neutralization tests (PRNTs), which are essential but time-consuming assays of vaccine efficacy. YuMi mixed virus and patient sera; IRB 1100 ran the repeated assay plates. The result was a fully robotic PRNT rigged to AI analysis software. This significantly increased throughput and removed biosafety risks to lab technicians. As ABB reported, by automating these tasks “the risk of exposing human operators to the virus is minimized” and handling large numbers of samples “helps to remove the scope for potential human errors”. The success of this pilot suggests that lab automation can boost pandemic responsiveness by enabling continuous, safe vaccine testing.
The Sterile Robotics case above deserves emphasis. Changchun Keygen Biological Products, China’s top chickenpox vaccine maker, replaced manual bioprocessing with 12 Stäubli robots, automating cell culture and virus growth in sealed “cell factories”. The robots handle delicate oscillation, inoculation and harvest steps. Notably, the plant achieved eight million dose capacity with zero human operators in the aseptic zone. This level of automation – combining robotics, sensors and pipeline controls – dramatically increases productivity and consistency. The key lesson is that full-scale robotic manufacturing can make traditional batch processes more like continuous, deterministic factories.
Despite these successes, many hurdles remain. Data integration is a persistent issue: HT screening, sequencing, animal studies and manufacturing data often reside in siloed formats. Combining genomic, proteomic, phenotypic and clinical datasets requires robust IT infrastructure and standardized data models. Tools for multimodal AI are still maturing, and most pharmaceutical companies lack seamless data pipelines. Without integration, the potential of AI and HT screening is blunted.
Regulatory alignment is another challenge. New methods – AI predictions, digital twins, in silico trials – must be validated to regulatory standards. There are few formal guidelines for AI/ML in vaccines, so companies must engage early with agencies. The FDA has signaled interest (e.g. discussing AI in lieu of animal tests and supporting PAT), but formal frameworks lag behind technology. This creates uncertainty for developers: will regulators accept a machine‐taught antigen or a digital model of a process? Bridging this gap will require collaboration and perhaps new regulatory paradigms (just as Quality by Design encouraged PAT two decades ago).
Cost and expertise also limit adoption. High‐throughput robots, single‐use plants and AI platforms entail large upfront investment and skilled personnel. Smaller biotech firms may struggle to afford this infrastructure. Moreover, AI models require high-quality training data; biased or incomplete datasets can lead to erroneous predictions (the “garbage in–garbage out” problem). As Elfatimi et al. caution, many AI models lack robustness in real-world vaccine R&D due to oversimplifications and bias. Ensuring the accuracy and interpretability of AI outputs is an ongoing concern.
Finally, technical limitations persist. Some assays (like viral potency) simply resist high-throughput measurement and still require laborious steps. High-throughput does not always mean high-quality – miniaturised assays must still correlate with in vivo immunity. The field must balance speed with scientific rigor.
The success of COVID mRNA vaccines has cemented nucleic-acid platforms as rapid-response tools. Future vaccines will likely leverage synthetic mRNA, self-amplifying RNA or DNA vectors that are “plug-and-play” once the gene sequence is known. High-throughput design tools – like Moderna’s GenAI platform – will optimise these constructs for maximal expression and minimal innate sensing. AI can also help devise universal or multivalent vaccines (for flu or coronaviruses) by analysing pan-genome data.
Digital twins will become more common. A twin of the entire vaccine process chain could integrate epidemiological models (disease spread) with supply chain and manufacturing models, enabling strategic planning for surge production. Internally, digital twins of fermenters or filling lines will allow ‘what-if’ simulations: for instance, predicting yield loss if a key nutrient fluctuates, or automatically adjusting conditions if a seed stock changes. The ability to simulate and optimise in silico promises better yield and quality without risking physical batches.
Advanced sensors and analytics will continuously monitor every step of production. We will see more PAT: e.g. inline spectroscopy to assess antigen concentration, biosensors for cell health, and even machine-vision checking of vials. These sensors feed AI-driven control loops that adjust feeding rates, temperature or oxygen to keep cultures at optimal productivity. Real-time release testing (assaying final product on the fly) is also on the horizon, potentially slashing lot release times.
Looking further ahead, technologies developed for infectious disease vaccines are bleeding into personalized medicine. Cancer neoantigen vaccines (tailored to an individual’s tumor mutations) require rapid antigen identification and same-day manufacturing – a perfect match for high-throughput and on-demand production. Similarly, rapidly mutating viruses (like HIV or dengue) may benefit from personalized immunogen designs guided by a patient’s immune profile. AI and micro-fabrication may eventually enable “vaccine-on-demand” devices that synthesize a candidate vaccine in hours from patient data.
Other innovations include synthetic biology and cell-free manufacturing, which could simplify production of complex antigens. Robotised “lab of the future” initiatives (with AI planning experiments) could shrink discovery timelines even further. Finally, improved Global collaboration and data sharing may arise: shared AI models for predicting outbreaks and vaccine efficacy, integrating public health data in real-time.
Integrated high-throughput technologies are reshaping vaccine R&D. Automated screening, robotics and AI have already delivered unprecedented speed – as seen in the COVID-19 response – and promise even greater efficiency in the future. By linking these tools through robust data platforms and incorporating them into manufacturing (through PAT, single-use systems and digital twins),arti stakeholders can bring safe and effective vaccines to market faster than ever. However, realising this promise requires overcoming challenges in data integration, regulatory acceptance and cost. With continued innovation and collaboration between tech developers, biologists and regulators, the vaccine field stands at the threshold of a transformative era.
PS:This article is intended for informational and educational purposes only. The content is based on insights derived from peer-reviewed publications, publicly available scientific literature, industry whitepapers, and real-world case studies. While every effort has been made to ensure accuracy and relevance, the information presented does not constitute regulatory guidance, clinical advice, or an endorsement of specific technologies or companies. Readers are encouraged to consult original sources and regulatory authorities for specific guidance related to vaccine development and biomanufacturing practices.
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