At Elise Biopharma, we believe that the transformative power of mRNA technology isn’t limited to human medicine—it’s poised to revolutionize animal health as well. With veterinary biologics poised to grow into a $7.17 billion market by 2024 (8.4 % CAGR), mRNA vaccines offer unprecedented speed, flexibility, and potency for disease prevention and treatment across livestock, companion animals, and aquaculture. Our end‑to‑end mRNA platform—built on a Quality by Design (QbD) framework—integrates discovery, process development, and GMP manufacturing to deliver field‑ready vaccines that meet global regulatory standards.
Introduction & Market Context
The success of mRNA vaccines in human pandemics has spotlighted their advantages: rapid design based on genetic sequence, modular manufacturing, and strong immunogenicity without reliance on live pathogens. In animal health, these benefits translate to:
- Rapid Response to Emerging Threats
When a novel swine influenza or avian flu strain emerges, our platform can pivot within weeks from genome sequence to candidate vaccine formulation—enabling priority field trials and emergency use authorization. - Modular Antigen Design
Whether targeting viruses, bacteria, or parasitic antigens, mRNA constructs can be rapidly reprogrammed. Multiple antigens may be combined in a single formulation, broadening protection. - Potent Immune Activation
mRNA‑encoded antigens mimic natural infection without the risk of live‑attenuated vaccines, eliciting both humoral and cellular immunity for durable protection. - Scalable & Cell‑Free Manufacturing
A fully cell‑free, enzymatic transcription process eliminates reliance on cell‑culture bioreactors—reducing complexity, contamination risk, and capital investment.
These attributes address urgent needs in livestock production (swine, poultry, cattle), companion‑animal care (canine, feline, equine), and aquaculture. As global pet ownership climbs and disease pressure intensifies, veterinary mRNA vaccines will become essential tools for veterinarians, producers, and regulators.
Quality by Design (QbD) Framework
Our mRNA vaccine development and manufacturing process is anchored in a Quality by Design philosophy, emphasizing predefined objectives, risk mitigation, and continuous improvement:
- Target Product Profile (TPP) Definition
We collaborate with you to define critical quality attributes (CQAs)—including antigen sequence fidelity, encapsulation efficiency, and immunogenicity benchmarks—aligned with expected field use and regulatory requirements. - Design of Experiments (DoE)
- Systematic studies optimize nucleotide modifications, codon usage, and 5′/3′ untranslated region configurations.
- LNP formulation variables (lipid ratios, particle sizing) are tuned to maximize delivery efficiency and stability.
- Process Controls & Critical Process Parameters (CPPs)
- Real‑time monitoring of transcription reactions, purification yields, and LNP assembly ensures batch‑to‑batch consistency.
- Defined control strategies trigger corrective actions if parameters drift outside established design space.
- Risk Management
- Failure Mode and Effects Analysis (FMEA) identifies high‑risk steps (e.g., nuclease contamination, oxidation).
- Mitigation plans (redundant filtration, antioxidant inclusion) are built into standard operating procedures (SOPs).
- Continuous Improvement
- Post‑lot review and trending analysis drive process refinements.
- Ongoing dialogue with clients ensures alignment with evolving regulatory expectations.
By embedding QbD principles from discovery through commercialization, Elise Biopharma guarantees that your mRNA vaccines are developed under a transparent, scientifically robust framework—minimizing surprises at scale‑up and regulatory review.
Our mRNA Manufacturing Platform
Elise Biopharma’s proprietary mRNA platform combines state‑of‑the‑art enzymology with flexible formulation capabilities, supporting all stages of commercial readiness:
- Cell‑Free Transcription & Purification
- High‑yield in vitro transcription using recombinant RNA polymerases
- Scalable chromatographic purification (ion‑exchange, size exclusion)
- End‑to‑end RNase‑free environment, achieving >98 % purity and minimal immunostimulatory byproducts
- Lipid Nanoparticle (LNP) Formulation
- Custom lipid chemistries tailored for target species and administration route
- Precision microfluidic mixing for uniform particle size (70–100 nm)
- In‑process controls: dynamic light scattering, encapsulation efficiency assays, endotoxin testing
- Finished‑Dose Formats
- Liquid Vials: ready‑to‑use sterile suspensions for intramuscular or subcutaneous injection
- Pre‑Filled Syringes: dose‑accurate, single‑use formats for field convenience
- Lyophilized Powders: shelf‑stable formulations enabling cold‑chain flexibility
- Dose Kits: modular components for multi‑valent or combination vaccines
- Analytical & Quality Control
- Potency assays: in vitro transfection followed by antigen quantification (ELISA, Western blot)
- Purity profiling: capillary electrophoresis, HPLC, and nucleoside analysis
- Sterility & bioburden: integrated testing per USP and VICH guidelines
This end‑to‑end capability—anchored in robust analytical methods—ensures that every batch meets predefined CQAs, enabling seamless transition from R&D to field trial and commercialization.
Cross‑Species Applications
Elise Biopharma’s mRNA vaccines address critical disease challenges in a variety of animal populations:
Livestock
- Porcine Reproductive and Respiratory Syndrome (PRRS)
Rapid development of mRNA encoding PRRS viral antigens demonstrated strong neutralizing‑antibody titers in pilot pig studies. - Avian Influenza
Modular mRNA constructs allow swift antigen swaps for emergent flu strains—minimizing culling and preserving supply chains. - Bovine Respiratory Disease Complex (BRDC)
Multi‑valent mRNA vaccines targeting key pathogens (BHV‑1, BRSV, M. haemolytica) combine antigens in one injection.
Companion Animals
- Canine Melanoma Vaccine
mRNA encoding tumor‑associated antigens stimulates cytotoxic T‑cells for durable anti‑tumor responses. - Feline Panleukopenia & Calicivirus
Combination mRNA vaccines offer comprehensive coverage in a single dose. - Equine West Nile Virus
LNP‑delivered mRNA enables seasonal boosters with minimal injection volume.
Aquaculture
- Viral Hemorrhagic Septicemia (VHS)
Oral mRNA‑LNP feed pellets protect trout against VHS – demonstrating 80 % survival in challenge trials. - Infectious Salmon Anemia (ISA)
Water‑stable LNP formulations for immersion vaccination reduce handling stress and labor.
By tailoring mRNA constructs, LNP chemistries, and administration routes, we meet the unique biological and logistical demands of each species group.
Integrated Development & Analytics
Our integrated services shorten timelines, reduce risk, and maximize success probability:
- Antigen Design & Sequence Optimization
- Bioinformatic epitope mapping identifies conserved immunogenic regions.
- Codon optimization for host‑specific expression.
- Stability & Stress Testing
- VICH stability protocols under accelerated and real‑time conditions.
- Forced degradation studies to map degradation pathways and shelf‑life.
- Method Transfer & Validation
- Standardized assay protocols adapted to client labs or contract testing facilities.
- Full validation packages (accuracy, precision, linearity, robustness).
- GLP Toxicology & Safety Studies
- In vivo safety evaluation per VICH guidelines (repeat‑dose toxicity, biodistribution).
- Immunogenicity profiling and cytokine panels.
- Tech Transfer Services
- Drafting of batch records, SOPs, and manufacturing training manuals.
- On‑site support at client or fill/finish partner facilities.
These end‑to‑end capabilities—from in silico design to clinical‑trial lot release—accelerate project milestones and de‑risk critical path activities.
Scale‑Up & Commercial Supply
Elise Biopharma’s scalable infrastructure is engineered for reproducibility and OTIF delivery:
| Scale Tier | Volume Range | Key Features |
|---|---|---|
| Laboratory Scale | 2–10 L | Feasibility runs, DoE studies, process definition |
| Pilot Scale | 50–200 L | Tech‑transfer batches, engineering runs |
| Production Scale | 500–2 000 L | Commercial manufacturing, bulk drug substance |
| Fill/Finish Partners | — | Aseptic filling (vials, syringes), lyophilization |
- On‑Time, In‑Full (OTIF) Commitment
Rigorous project management ensures alignment of raw‑material sourcing, capacity planning, and batch sequencing. - Supply Chain Resilience
Dual‑sourcing of critical enzymes and lipids minimizes disruption risk. - Cold‑Chain Optimization
Flexible packaging and shipping solutions, including dry‑ice, refrigerated, or controlled room‑temperature kits.
Whether launching pilot field‑trial lots or supporting multi‑site commercial deployment, our teams coordinate closely with yours to meet program timelines and volume forecasts.
Regulatory & Tech‑Transfer Support
Navigating global veterinary regulations can be complex. We help you prepare dossiers that satisfy:
- USDA APHIS for transmissible disease vaccines
- FDA CVM for new animal drug applications (NADAs)
- EMA VICH harmonized guidelines for quality, safety, and efficacy
Our deliverables include:
- CMC Documentation: eCTD‑ready modules covering process descriptions, analytical methods, and validation data
- Risk‑Based Approach: Justifications for platform technologies and bridging data to human mRNA precedent
- Conditional Licensure Strategies: Rolling data submissions to expedite field deployment
- Post‑Approval Change Management: Lifecycle management plans for strain updates or formulation tweaks
In addition to dossier preparation, we provide hands‑on tech‑transfer support—training your team or third‑party fill/finish partners, reviewing batch records, and troubleshooting process deviations to ensure a seamless transition.
Why Elise Biopharma?
- True Animal‑Health Focus
- Dual expertise in microbial and mRNA platforms uniquely positions us to address veterinary needs.
- QbD Rigor Across Discovery to Commercial
- Science‑driven process development ensures consistent quality and regulatory confidence.
- Multi‑Format Dosage Capabilities
- From vials and pre‑filled syringes to lyophilized and oral formulations, we support diverse field demands.
- Global Regulatory Literacy
- In‑depth knowledge of USDA, FDA CVM, and EMA VICH frameworks accelerates approvals worldwide.
- Responsive Project Teams
- Dedicated program managers and technical leads keep you informed and on schedule.
At Elise Biopharma, your veterinary mRNA vaccine isn’t just another project—it’s a partnership in innovation and animal welfare. We bring the same scientific depth, quality systems, and agile execution that have defined our human‑health successes to every veterinary program.
Next Steps
Ready to harness the power of mRNA for your animal‑health program?
Contact our mRNA Vaccine Experts today to discuss feasibility, timelines, and project plans. Email info@elisebiopharma to directly contact our team!