Integrated solution for animal mRNA vaccines

mRNA technology, as a new generation of vaccine manufacturing technology, continues to break through and expand its applications in the field of human infectious diseases. Compared to traditional attenuated/inactivated virus vaccines and subunit protein adjuvant vaccines, mRNA vaccines offer advantages such as lower development costs, shorter development cycles, higher safety, simpler processes, and stronger efficacy. Additionally, the natural adjuvant effect of mRNA vaccines can stimulate robust cellular immunity, leading to significant preventive effects against many infectious diseases. Moreover, mRNA vaccines are particularly suitable for developing multivalent vaccines, which can simplify vaccination procedures and reduce costs. They can serve as an ideal choice for rapid development of vaccines for unmet needs in animal infectious diseases or for rapid technological iterations, such as developing multivalent vaccines or improving protection rates for existing animal infectious disease vaccines. However, the application of mRNA technology in the veterinary field is limited by the stability and comprehensive cost of mRNA vaccine products.

EnoBio provides comprehensive, proprietary intellectual property technology services from antigen design to clinical sample production and regulatory submission. Clients can choose from a complete integrated solution or individual modules/technical solutions according to their specific needs, including AI-assisted antigen protein design, multi-antigen mRNA design and synthesis, mRNA-LNP lyophilization technology (leading global nanomedicine thermal stability technology1), immunostimulatory cap analogs, targeted LNP delivery systems, and immunostimulatory UTR and poly A tails. Leveraging proprietary intellectual property technologies, critical raw materials, and research and development production equipment supply chains, EnoBio can not only address the stability and comprehensive cost challenges of animal mRNA vaccine products but also meet various demands for the development of animal vaccines with full intellectual property control.

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case study:

Application Characteristic Analysis Key Capability Elements for Characteristics
Multivalent mRNA vaccines for cats/dogs Multivalent vaccines with high accessibility and cost requirements, Intellectual Property Needs Design and synthesis of multi-antigen expression using multi-cistronic mRNA sequences.
mRNA-LNP lyophilization technology (ambient temperature or conventional cold chain storage)
Key raw materials and production equipment (independently controlled supply chain, easy scalability and cost control).
African Swine Fever mRNA vaccine High requirements for antigen selection, Original antigen structure design and homologous protein sequence design
  accessibility, and cost control, Intellectual Property Needs mRNA-LNP lyophilization technology (ambient temperature or conventional cold chain storage)
Key raw materials and production equipment (independently controlled supply chain, easy scalability and cost control).
Fully proprietary intellectual property

1.Lyophilized mRNA-lipid nanoparticle vaccines with long-term stability and high antigenicity against SARS-CoV-2. . 2023, 9(1): 9

Development process:

Antigen discovery and drug design

Epidemiological antigen prediction Original

antigen structure design

Homologous protein sequence design

High-expression and high-stability mRNA design

mRNA sequence CDS optimization

Enhanced expression UTR elements*

mRNA optimization and synthesis

Spleen or lymph node-specific mRNA cap analogs*

Enhanced expression and stability with poly A tails*

Design and synthesis of multi-epitope mRNA sequences (encoding multiple antigens)

Fully proprietary mRNA synthesis without IP risk

LNP delivery and formulation development

Spleen or lymph node-targeted LNP delivery system*

LNP formulation DOE screening for target mRNA and indications

mRNA-LNP lyophilization technology*

Research-grade mRNA-LNP encapsulation equipment*

Immunogenicity and safety pre-evaluation

Protein expression detection

Animal model construction

Humoral immune detection

Cellular immune detection

Animal challenge studies

Preliminary safety assessment

Process development and GMP-level production

High-genetic stability plasmid engineering bacteria*

Plasmid Tier III library construction, process development, and GMP production

mRNA bulk process development and GMP production

Lyophilized formulation process development and GMP production*

Quality method development and research

GMP-like raw material production and supply*

Industrial-scale mRNA-LNP encapsulation equipment*

Safety evaluation and regulatory submission

Toxicology evaluation

In vivo distribution characterization

Pharmacology data writing

IND submission service

* Available proprietary intellectual property solutions