DNA vaccines and mRNA vaccines share similarities in that both can encode any antigen related to pathogenic microorganisms or tumors, and can stimulate the immune response without the need for viral vectors or adjuvants. However, in terms of structure, DNA vaccines are more stable than mRNA vaccines. In addition to their use in infectious disease prevention, DNA vaccines have also accumulated rich clinical experience in the field of tumor therapy. DNA vaccines have a significant market application in both human and veterinary vaccine fields.
Yaohai Bio-Pharma, with its powerful process development platform and extensive experience in plasmid DNA production, can provide customers with a one-stop solution from plasmid DNA strain development to GMP production. We flexibly adjust the service process according to the customized needs of customers and provide high-quality DNA Drug Substance (DS) or Drug Product (DP) in quantities ranging from ten grams to hundreds of grams, as well as complete development and GMP production records and testing reports.
Grade | Deliverables | Specification | Applications |
non-GMP | Drug substance | 0.2~10 g (plasmid DNA) |
Preclinical studies, Analytical method development, Pre-stability studies, Formulation development |
Drug product | |||
GMP, Sterile | Drug substance | 10~100 g (plasmid DNA) |
Investigational new drug (IND), Clinical trial authorisation (CTA), Clinical trial supply, Biologic license application (BLA), Commercial supply |
Drug product | 20,000vials (liquid or lyophilized), pre-filledsyringes or cartridges |
Vaccine Type |
Customers Need |
Yaohai's Solutions |
Therapeutic DNA Vaccine |
Fermentation process development: Focus on plasmid DNA production |
We developed animal-free media and fermentation process of the engineered Bacteria E. coli, and the fed-batch fermentation yield exceeding 1000 mg/L of plasmid DNA. |
Vaccine Type | Technology Difficulties | Yaohai's Deliverables |
Prophylactic DNA Vaccine |
Under the original process of the customer, HCD exceeded the quality standard, and the proportion of plasmid superhelix was about 80%. Process Development Objectives: Residual HCD 1%; The proportion of superhelix plasmids 90%. |
We optimized the purification process according to the critical quality attributions. Testing results of pladmid samples: The proportion of superhelix was 95%; The HCD residue was 1%; HCP and endotoxin residues met the quality standards. |
We have developed a plasmid DNA analysis protocol based on capillary gel electrophoresis with laser-induced fluorescence detection (CGE-LIF). This method effectively separates plasmid DNA of various conformations with high resolution and good reproducibility.