Vaccines are the most economical and effective means for preventing and controlling infectious diseases. With scientific advancements, vaccine theories and technologies have continuously achieved breakthroughs, evolving from traditional attenuated and inactivated vaccines to novel types including recombinant protein vaccines, peptide vaccines, virus-like particle (VLP) vaccines, DNA vaccines, and mRNA vaccines. This progress has expanded the range of infectious diseases that can be medically conquered. InnoStar's integrated non-clinical-to-clinical bioanalysis platform, leveraging extensive toxicology expertise and superior animal model resources, offers comprehensive vaccine evaluation services spanning non-clinical assessments to bioanalytical testing.

InnoStar Vaccine Product Service Solutions

Early-Stage Vaccine Research

-Identification tests using serological, biological, and nucleic acid sequence analysis methods
-Detection of bacterial/viral strain amplification capacity and infectious titer, with establishment of correlation data between these parameters and vaccine efficacy
-Immunogenicity evaluation of bacterial/viral strains

Non-Clinical Safety Evaluation

-General toxicology
-Local irritation
-Immunotoxicity
-Reproductive toxicity
-Genotoxicity
-Long-term toxicity
-Special safety assessments

Non-Clinical Efficacy Studies

-Cell line modification and optimization
-Diverse animal models
-Challenge experiments
-Immunoprotective mechanism research
-Vaccine Pharmacokinetics
-Absorption, distribution, metabolism, and excretion processes in vivo

Vaccine Immunogenicity Analysis

-Humoral immune response analysis: Antibody level detection, antibody subtype profiling, neutralizing antibody and pseudovirus neutralization assays, mucosal antibody testing
-Cellular immune response analysis: Enzyme-linked immunospot (ELISPOT) assay, cytotoxic T lymphocyte (CTL) assessment, T-cell subset/B-cell subset detection
 

Pathogen Identification

-Pathogen isolation and cultivation
-Pathogen PCR and NGS typing
-Serotype identification

Project Experience

Innostar has completed 56 vaccine-related drug development projects, encompassing IND application studies, NDA application studies, early screening, and other non-regulatory research (efficacy, pharmacokinetic experiments, etc.). The portfolio covers preventive and therapeutic vaccines, including cutting-edge modalities such as mRNA vaccines.