A dedicated solution provider of cellular therapy products

CDMO Services for CAR-T Cells - IIT grade/non-clinical phase

TCR-T cells, i.e. T-cell receptor-engineered T cells, are constructed to enable T cells to specifically kill the tumor cells by inserting the TCR chains that can specifically recognize the tumor antigen into T cells through gene engineering. Hillgene is specialized in provision of integrated CDMO solutions for cellular therapy products, has established a completely closed process development platform for cellular therapy products, and therefore, can provide high-quality CDMO services for cells to clients with various demands.


CDMO Services for TCR-T Cells (HiCellx® Technology Platform)
IIT grade1Dossier Preparation

● Ethical approval

● HGRAC approval

● Seamless connection to IND submission

● GMP-like workshop

● Authentic and traceable documentation

● GMP-like quality management system

● Manufactured 200+ batches

2Process Development

● Following project requirements (subject to customized changes)

3Process Validation

● Manufacturing for 3 consecutive batches, meeting the project design requirements and specifications

4Storage Stability

● Following project requirements (subject to customized changes)

5Shipping Stability

● Following project requirements (subject to customized changes)

6Cell Manufacturing and Testing (GMP-like)

● Connecting shipment

● Production scale: 200 mL~20 L (subject to customized changes)

● Process route: flexible process design and subject to customized changes

*Note: We offer relatively flexible and customized changes to above services, including but not limited to above services. 


Advantages of using our HiCellx® technology platform:

• Using independently developed cryopreserved cell preparation 

• Using closed and automated cell culturing equipment, the same as the global mainstream companies

• Cell workshop compliant with clinical and commercial requirements: grades B+A, unidirectional air flow, Full-GMP

• Cell proliferation with higher rate, solved the issues of low positive rate and proliferation rate

• Flexibly suitable for manufacturing and testing of various cellular therapy products 

• Extensive experience in using the closed and automated cell culturing equipment 

• Experience in manufacturing of 200+ IIT clinical samples 

• Experience in IND submission of a TCR-T cell product, which was successfully approved by NMPA

• Experience in supporting the technology transfer of clinical batch of TCR-T cell products and in manufacturing of cell samples for clinical use

Manufacturing process

Quality control

TypesTest ItemTest Method
Physicochemical PropertiesAppearanceVisual inspection
pHMethod 0631 of ChP 2020
PurityCD4/CD8Flow cytometry
Biological functionsCell countsFluorescence staining
Cell viabilityFluorescence staining
TCR positive rateFlow cytometry
CytotoxicityAs per Protocol
SafetyNumber of TCR gene copiesq-PCR
EndotoxinMethod 1143 of ChP 2020
RCLRCL (No positive control group)
SterilityMethod 1101 of ChP 2020
Sterility (Rapid Test)Rapid testing

*Note: Hillgene established QC methods corresponding to different technology platforms, with QC methods including but not limited to above items. 

Project Timeline

Project Management Plan

Hillgene Project Management Team, consisting of chief scientists, project managers, Project QA and GMP experts, will make efforts to ensure the smooth and sound operation of each and every GMP project.