Leave a Message

Cell & Gene therapy has developed rapidly in recent years, providing the possibility of curing many difficult-to-treat cancers. With the rapid development of gene transduction and gene modification technology, delivery vector system, cell culture technology and other fields, gene therapy has made a breakthrough, provide a better solution, concept and idea for intractable diseases (especially rare genetic diseases). 

Medicilon has established a one-stop research platform for the preclinical R&D of Cell & Gene immunotherapies, covering a variety of immunotherapy methods including CAR-T, TCR-T and CAR-NK. Using a wealth of animal models and a variety of advanced analysis techniques, comprehensively considering the characteristics of different research projects, Medicilon has completed multiple preclinical projects for clients worldwide.

Cell & Gene Therapy Preclinical Research Content

Pharmacodynamic Research

Medicilon boasts nearly 300 tumor evaluation models. At the same time, we are empowering innovative therapies to comprehensively evaluate and study immuno-oncology. We have completed model establishment and efficacy evaluation of immuno-therapies such as CAR-T, TCR-T, CAR-NK, oncolytic virus, antibody (monoclonal antibody, double antibody, polyclonal antibody, etc.), siRNA, AAV.

Pharmacodynamic Studies
❖ Tumor killing rate or proliferation inhibition rate
❖ Expression of IFN-γ
❖ Phenotypic changes of CAR-T cells

Technical Method
❖ Bioluminescent Imaging (BLI)
❖ Flow Cytometry
❖ Immunoassay Technology
❖ Pathology Technology

Pharmacokinetic Research

Cell & Gene therapy products should be analyzed and evaluated according to the specific characteristics of the product, taking into account the actual exposure in non-clinical studies. The bio-distribution of cell & gene therapy products is the distribution, persistence and clearance of gene therapy products in target and non-target tissues in the body.

Technology Platform
❖ Imaging Technology
❖ Flow Cytometry
❖ Immunohistochemistry Technology
❖ Quantitative PCR Technology
❖ ddPCR
❖ ELISPot

Preclinical Safety Studies

Cell & Gene therapy products should be capable of effective introduction/exposure in the relevant animal species. The non-clinical safety studies of cell therapies (such as CAR-T cells) include: cytokine release syndrome (CRS), reversible neurotoxicity, B cell reduction, on-target/off-tumor, CAR- T cell tumorigenicity, etc.

Technology Platform
❖ General Toxicology
❖ Immunogenicity
❖ Immunotoxicity
❖ Reproductive toxicity
❖ Genotoxicity
❖ Neurotoxicity
❖ Carcinogenicity

Case Studies

Medicilon Cell & Gene Therapy Drug Service Qualification

Medicilon Toxicology Research Department has been granted AAALAC Accreditation and GLP certificate of NMPA and passed the on-site evaluation, with research globally recognized capabilities to support filing programs for multiple countries.

Service Modules
❖ Pharmacological/Pharmacodynamic research
❖ Bio-distribution
❖ Immunogenicity
❖ Drug Safety Evaluation
 
Service Types
❖ Cell Therapy
❖ Oncolytic Virus
❖ Oligonucleotide
❖ Gene Editing

Contact Us
E-mail: 
marketing@medicilon.com
Address:
585 Chuanda Rd, Pudong, Shanghai, China, 201299 (Headquarters）
1 Broadway, 9th Fl, Cambridge Innovation Center, Cambridge, MA 02142, US
Kelvinstraat 41b, 6601 HH Wijchen, The Netherlands
Allia Future Business Centre Kings Hedges Road Cambridge CB4 2HY, UK