Cell therapy drugs are a molecular form of precision treatment achieved by connecting different functional molecules (such as cytokines, targeting ligands, etc.). InnoStar has systematically addressed the challenges in the research process and successfully established a non-clinical evaluation system recognized by regulatory agencies in the field of cell therapy drugs. InnoStar possesses the professional capability to support global multi-center submissions and is committed to providing partners with efficient and reliable R&D services to accelerate innovative drug development. we has cumulatively served over a hundred cell therapy product development projects, several of which are "first-in-class" innovations domestically and internationally.

InnoStar Cell Therapy Drug Services
Early Screening Strategies for Cell Therapy Drug Products

-Cell Source and Purity Screening: Assess the compliance of stem cell/CAR-T cell sources and the purity of target cell subpopulations.
-In Vitro Functional Activity Preliminary Screening: Detect key functional indicators such as cell proliferation, differentiation, antigen recognition, or tumor-killing activity.
-Preliminary Immunogenicity Assessment: Analyze the compatibility of allogeneic cells with the host immune system and screen for low-immunogenicity candidate cells.
-Species Cross-Reactivity Analysis: Investigate the interaction compatibility between cell therapy products and the immune microenvironment of animal models.
-In Vivo Colonization and Distribution Preliminary Experiments: Use fluorescent labeling or bioluminescence imaging to preliminarily observe cell migration and enrichment capabilities in vivo.

Non-Clinical Pharmacokinetics

-In Vivo Colonization and Distribution: Detect the survival time, proliferation dynamics, and clearance patterns of cells in target organs/tissues, evaluating targeting efficacy.
-In Vitro Expansion Kinetics: Examine cell proliferation rates, phenotypic stability, and functional maintenance during in vitro culture.
-Immune Cell Interaction Studies: Analyze the interaction patterns between therapeutic cells and host immune cells (e.g., T cells, macrophages).
-Cell Survival Marker Detection: Track biomarkers of cell survival and functional status in vivo using flow cytometry or molecular imaging.

Non-Clinical Safety Evaluation

-Safety Pharmacology: Evaluate the direct or indirect effects of cell therapy products on critical system functions (cardiovascular, respiratory, central nervous systems).
-General Toxicology: Investigate short-term/long-term toxicity of different cell doses in animals, combined with histopathology and cytokine profile analysis.
-Immunogenicity/Immunotoxicity: Detect risks such as cytokine release syndrome (CRS), neurotoxicity, or immune rejection triggered by allogeneic cells.
-Reproductive Toxicity Testing: Assess potential impacts of reproductive system-related cell therapies on gametogenesis, embryonic development, and offspring.
-Tumorigenicity Assessment: For stem cells or gene-edited cells, detect risks of abnormal proliferation or tumorigenesis due to chromosomal aberrations.
-Local Tolerance Testing: Evaluate inflammatory responses, tissue damage, and repair capacity at cell infusion/transplantation sites.
-Formulation Stability: Examine cell survival rates, functional integrity, and microbial contamination risks during freezing, thawing, and transportation.

Clinical Bioanalysis

-Biomarker Analysis: Assess correlations between cell survival, proliferation, and functional markers (e.g., CAR gene expression in CAR-T cells, differentiation antigens in stem cells) and efficacy/toxicity.
-Cell Counting and Phenotypic Analysis: Use platforms like flow cytometry for quantitative and phenotypic identification of therapeutic cells in biological matrices.
-Immunogenicity Analysis: Employ ELISA or cytotoxicity assays to evaluate anti-cell antibodies or host immune activation responses.
-Functional Activity Testing: Assess the targeted functional activity of therapeutic cells through in vitro killing assays, cytokine secretion profiles, etc.
-Long-Term Safety Monitoring: Track the persistence of post-treatment cells, gene integration sites, and potential delayed toxicity signals.

Project Experience

- Completed: Over a hundred new drug R&D projects, with nearly 30 NMPA IND approvals, including several successful China-U.S. dual IND submission projects.

Partner with InnoStar for your cell therapy program and accelerate your path from discovery to approval with confidence.