Service Introduction
InnoStar's specializes in providing comprehensive technical support for clinical vaccine development, including analytical method development, validation and biological sample testing. Our services strictly follow the regulatory requirements of NMPA, FDA, OECD, EMA and ICH to ensure data compliance and reliability. For biological sample analysis, we provide a number of key services such as humoral immunoassays (ADA, NAb), cellular immunoassays (ELISPpot), PK assays (mRNA,LNP), cytokine assays (Biomarker) as well as flow immunocytotyping and intracellular staining (ICS) assays. With rich project experience in recombinant subunit vaccines and mRNA vaccines, we are committed to providing high-quality and comprehensive technical support for vaccine development.
Service Content
-PK analysis of mRNA vaccines (qPCR and LNP: LC-MS/MS)
-Protein and cytokine analysis (ELISA, Luminex, MSD, CBA, Simoa etc.)
-Cellular immune response (ELISpot)
-Antibody potency assays (ELISA, Luminex)
Type of drug
-mRNA-based (mRNA vaccines, mRNA-related products)
-Conventional multivalent vaccines (ELISA, Luminex)
-Recombinant subunit vaccine
Detectable Substrates
-Plasma
-Serum
-Whole blood (or PBMC)
Core Equipment & Platforms
-Mass Spectrometer
-Enzyme Labeler
- MSD
- Luminex
- Flow Cytometer
-qPCR
- ddPCR Instrument
- Enzyme-linked immunospot analyzer
- Western Blot
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