Service Introduction
InnoStar's  Bioanalytical Platform is able to provide NMPA/FDA/EMA/ICH compliant clinical bioanalytical services to support the development and validation of bioanalytical methods and clinical sample testing for viral vectors (AAV, LV, AdV), cellular therapeutic products (CAR-T, Stem Cells, TIL), gene editing drugs (mRNA-LNP,siRNA), oncolytic viruses, oncolytic bacteria, neoantigens, etc. Bioanalytical method development, validation and clinical sample testing for cell and gene therapy products. The team has rich experience in CGT bioanalysis and is equipped with a computerized system that fully meets the GLP requirements to ensure the efficient advancement of clinical research and to safeguard the traceability, integrity and compliance of data.

The platform is equipped with flow cytometer, microtitre digital PCR, qPCR, enzyme labeling, electrochemiluminescence, ELISpot Reader, sequencer, etc., which can accurately meet the requirements of cell kinetic analysis, vector copy number analysis, biodistribution and shedding analysis, RCR/RCL analysis, protein expression analysis, immunogenicity analysis, specific cellular immunoreaction analysis, integration site analysis, and other data analysis requirements. immunogenicity analysis, specific cellular response analysis, integration site analysis and other key analytical needs, comprehensively covering pharmacokinetics (PK), pharmacodynamics (PD) and safety evaluation for clinical development of cellular and gene therapy drugs.

Service Content
-PK analysis
-Shedding analysis
-RCR/RCL assay
-Protein and cytokine analysis
-Anti-Drug Antibody Analysis
-Neutralizing antibody analysis
-Viral activity analysis
-Pharmacodynamic analysis (immunophenotyping, receptor occupancy, intracellular cytokines, expressed protein analysis, etc.)
-Cellular immune response (ELISpot)  
-Integration site analysis
-Sequencing analysis
-Immunohistochemistry/immunofluorescence analysis

Types of drugs
-Immune cell therapy products (CAR-T, CAR-NK, TIL)
-Stem cell therapy products (umbilical cord mesenchymal stem cells, amniotic membrane epithelial stem cells)
-Oncolytic viruses (herpes virus, adenovirus, soluble expression products of oncolytic viruses)
-Adeno-associated virus (AAV)
-mRNA (mRNA vaccines, mRNA-related products)
-Oligonucleotides (siRNA, circle RNA, etc.)
-New antigens

Detectable Substrates
-Plasma
-Serum
-Whole blood
-Bone marrow
-Cerebrospinal fluid
-Urine.
-Feces.
-Saliva
-Tissue