Veterinary biotech & mRNA veterinary drugs

01Overview and value chain#

Markers EC: Regulation (EU) 2019/6 | OECD: biotech-health | Regulator: USDA (USA), EMA (EU)

Veterinary biotechnology leverages advanced genetic engineering, mRNA platforms, and recombinant protein expression to develop next-generation vaccines and therapeutics for companion animals and livestock. Driven by the need to combat zoonotic spillovers, African Swine Fever (ASF), and avian influenza, these platforms enable rapid sequence-to-vaccine timelines—sometimes under 8 weeks. With over 70% of new human infectious diseases originating in animals, the sector integrates One Health principles, prioritizing rapid-response RNA particle technology, lipid nanoparticle (LNP) delivery, and scalable cell-culture manufacturing to ensure global food security and animal welfare.

The key directions of veterinary biotech are:

1. mRNA and RNA particle vaccines: Delivers pathogen-specific genetic sequences directly into cells, eliciting robust immune responses without using live viruses.
2. Recombinant protein therapeutics: Engineered monoclonal antibodies for companion animal chronic diseases, such as osteoarthritis and atopic dermatitis.
3. Viral vector platforms: Utilizes harmless carrier viruses to present specific antigens to the animal’s immune system, offering stable, single-dose protection.
4. Diagnostic biomarkers: Advanced molecular diagnostics and point-of-care PCR tests for real-time herd health monitoring and outbreak containment.

Sectoral value chain#

[Pathogen genomics] ──> [Antigen design] ──> [Biomanufacturing] ──> [Formulation]
                                                 │
                                           (LNP/Adjuvants)
                                                 │
                                                 ▼
[Herd immunity] <─── [Veterinary delivery] <─────┘

Value chain levels#

Cross-cutting technologies of the sector:

• Lipid nanoparticle (LNP) delivery: Ensures mRNA stability in non-human physiological conditions.
• Microfluidic encapsulation: Scalable systems for mixing mRNA with lipid matrices.
• Cold-chain logistics: Specialized supply chains for thermolabile veterinary biologics.

02US#

The US market leads in the rapid authorization and deployment of RNA-based veterinary biologics, largely driven by USDA’s progressive regulatory pathways and massive livestock industries.

Rapid-response vaccines, Companion animal therapeutics, Swine health#

• Sequivity RNA platforms: USDA-approved custom swine vaccines developed from sequence to farm in weeks.
• Companion animal biologics: High adoption of monoclonal antibodies for canine and feline chronic conditions.
• Avian influenza preparedness: Heavy investment in mRNA vaccine stockpiles for poultry following widespread highly pathogenic avian influenza (HPAI) outbreaks.

03CN#

China prioritizes veterinary biotech as a matter of national food security, investing heavily in recombinant and mRNA vaccines to protect its massive swine and poultry populations.

Swine disease control, High-throughput manufacturing, Food security#

• African Swine Fever (ASF) vaccines: National push for advanced biologics to mitigate devastating economic losses in the pork industry.
• State-backed mega-facilities: Construction of high-capacity biosafety level 3 (BSL-3) manufacturing plants for veterinary biologics.
• Rapid commercialization: Accelerated regulatory tracks by the MoA for vaccines targeting economically critical livestock diseases.

04EU#

The EU emphasizes a One Health approach, focusing on reducing antimicrobial resistance (AMR) in livestock through advanced prophylactic vaccines and strict regulatory oversight.

AMR reduction, One Health framework, Stringent regulation#

• Phasing out antibiotics: Strong regulatory pressure to replace prophylactic antibiotics with next-generation vaccines in farming.
• Centralized EMA approvals: Harmonized, rigorous authorization pathways for novel veterinary therapies across member states.
• Zoonotic disease monitoring: Cross-border integration of veterinary diagnostics and human health surveillance systems.

05Leading companies and research institutes#

06Tech stack and innovations#

Modern veterinary biologics rely heavily on cell-free synthesis, advanced delivery vehicles, and precision immunology to bypass traditional egg-based or live-attenuated production constraints.

1. Self-amplifying mRNA (saRNA):
   • Engineered RNA constructs that replicate their antigen-encoding sequences upon entering host cells.
   • Allows for microgram-level dosing (e.g., 1–5 µg per dose), significantly reducing the cost per animal compared to conventional mRNA.
2. RNA Particle Technology (e.g., Sequivity):
   • Uses a non-replicating alphavirus backbone to deliver genetic instructions directly to dendritic cells.
   • Requires only a digital sequence of the pathogen, bypassing the need to culture live dangerous viruses in biosafety facilities.
3. Monoclonal Antibodies (mAbs) for Companion Animals:
   • Species-specific (caninized or felinized) antibodies developed via recombinant DNA technology.
   • Targets specific interleukins (e.g., IL-31 for itch) with a half-life permitting monthly dosing.

07Value chains and production pipelines#

Industrial pipeline of veterinary mRNA vaccine manufacturing (cGMP)#

┌───────────────────────────┐      ┌───────────────────────────┐
│ 1. Plasmid DNA production │ ───> │ 2. In vitro transcription │
└───────────────────────────┘      └───────────────────────────┘
                                                 │
                                                 ▼
┌───────────────────────────┐      ┌───────────────────────────┐
│ 4. LNP encapsulation      │ <─── │ 3. mRNA purification    │
└───────────────────────────┘      └───────────────────────────┘
              │
              ▼
┌───────────────────────────┐      ┌───────────────────────────┐
│ 5. Sterile fill and finish│ ───> │ 6. Cold-chain storage     │
└───────────────────────────┘      └───────────────────────────┘

Stage 1: Plasmid DNA production

E. coli fermentation is used to amplify plasmid DNA containing the target antigen sequence, which is then purified and linearized to serve as a template.

Stage 2: In vitro transcription

The linearized DNA template is mixed with RNA polymerase and nucleotide triphosphates (NTPs) in a cell-free bioreactor to synthesize the mRNA strands.

Stage 3: mRNA purification

Chromatographic techniques (such as affinity or ion-exchange chromatography) remove residual DNA templates, enzymes, and truncated RNA fragments to yield highly pure mRNA.

Stage 4: LNP encapsulation

The purified mRNA is combined with a precise mixture of ionizable lipids, cholesterol, and PEG-lipids in microfluidic mixers to form stable lipid nanoparticles.

Stage 5: Sterile fill and finish

The LNP-formulated vaccine undergoes tangential flow filtration for buffer exchange, followed by sterile filtration and automated filling into veterinary multi-dose vials.

Stage 6: Cold-chain storage

Vials are visually inspected, labeled, and placed in ultra-low temperature freezers or standard refrigeration (depending on lipid stability) for distribution to farms and clinics.