Integrated Solution for mRNA Vaccines Against Infectious Diseases

Compared with traditional attenuated/inactivated virus vaccines and subunit protein adjuvant vaccines, mRNA vaccines have the advantages of lower development costs, shorter development cycles, higher safety, simpler processes, and stronger efficacy. Moreover, the natural adjuvant effect of mRNA vaccines can stimulate robust cellular immunity, particularly effective in preventing many infectious diseases, especially recurring latent infections. mRNA technology has become the ideal choice for the development of new generation vaccines and the iteration of traditional vaccines.

EnoBio provides a comprehensive solution with independent intellectual property rights, covering the entire chain from antigen design to clinical sample production and regulatory submission. Customers can choose integrated or single-module/technical solutions according to their needs, including AI-mediated antigen protein design (DMC.AI platform), antigen mRNA design and synthesis, mRNA-LNP lyophilization process (globally leading nanoformulation thermal stability technology1), immune-enhancing cap analogs, targeted LNP delivery systems, and immune-enhancing UTR and poly A tails, among others. By combining the aforementioned proprietary technologies, key raw materials, and research and development production equipment supply chain,EnoBio can not only address the challenges of mRNA vaccine stability and comprehensive product costs but also meet customers' needs for the development and independent control of various vaccines across the entire chain.

blog

case study:

Application Characteristic Analysis Key Capability Elements for Characteristics
COVID-19 Vaccine Emerging disease demands fast, safe vaccine for everyone Antigen design (proprietary and enhanced safety and efficacy).
mRNA-LNP lyophilization process (addresses accessibility).
Key raw materials and production equipment (independently controlled supply chain, easy scalability).
Varicella zoster virus Vaccine Requires strong immunity, safety, and IP protection. Cap structure optimization (tissue specificity, enhanced cellular immunity)
Targeted LNP delivery system (improved safety and efficacy)
Fully proprietary intellectual property
Respiratory Syncytial Virus Vaccine Intellectual property needs with antigen still under patent protection. Homologous protein sequence design (proprietary with enhanced efficacy)
Targeted LNP delivery system (improved safety and efficacy)
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 quality attribute 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