InnoStar
Shanghai-based nonclinical CRO with GLP safety evaluation, pharmacology, DMPK, bioanalysis and biomarker services for small molecules, biologics and cell and gene therapies, operating several sites in China.
About Cell Therapy
Cell therapies are living products, so preclinical work asks questions that drug studies do not: where the cells go, how long they survive, whether they expand, and whether they form tumors or attack healthy tissue. Most studies use immunodeficient mice, such as NSG or related strains, because human cells are rejected by a normal mouse immune system.
CAR-T and other engineered immune cell programs are usually tested in human tumor xenograft models, with efficacy read by tumor volume, bioluminescence imaging or survival. Biodistribution and persistence are commonly measured by qPCR for human-specific DNA sequences or for the transgene, by flow cytometry of blood and tissues, or by in vivo imaging of labeled or reporter-expressing cells. Graft-versus-host disease in the mouse can limit study length and confound results, so experienced labs plan endpoints around it.
Safety packages for cell therapies are tailored rather than standardized, and regulators expect tumorigenicity and off-target assessments that fit the product. Talk to the CRO early about cell handling on dosing days: shipping, thaw, viability checks and the time from thaw to injection all affect the result.
Preclinical Cell Therapy CROs
Showing 1 CRO. Order rotates daily so no lab is permanently listed first.
Questions to ask when choosing a Cell Therapy CRO
- Which immunodeficient strains do you use, and how do you manage graft-versus-host disease in long studies?
- How do you measure biodistribution and persistence: qPCR, flow cytometry, imaging, or a combination?
- What is your process for receiving, thawing and checking cell viability before dosing?
- Have you run tumorigenicity or ectopic tissue formation studies for cell products?
- Can efficacy, biodistribution and safety endpoints be combined in one study?