Building 4, Yuewang Wisdom Valley, 1463 Wuzhong Avenue, Wuzhong District, Suzhou, China
CAR-T cells, i.e. the Chimeric Antigen Receptor T Cell, work in the principle of utilizing the patient’s own T lymphocytes, which are re-engineered in the lab, loaded with receptors recognizing the tumor-antigen, proliferated ex vivo, and subsequently re-infused to the patient, to recognize and attack the tumor cells. 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.
Services
| CDMO Services for CAR-T Cells (HiCellx® Platform) | ||||
| Types | Services | |||
| IND grade | 1 | Process and Test Method Development | ● Following project requirements (subject to customized changes) | ● Full-GMP compliant Workshop of B+A grade with unidirectional air flow ● GMP quality management system ● Several successful submissions in China |
| 2 | GMP Manufacturing of CAR-T Cells | ● Connecting shipment ● Production scale: 200 mL~20 L (subject to customized changes) ● Process route: flexible process design and subject to customized changes | ||
| 3 | Testing of CAR/TCR-T Cells | ● Purity (CD3+) ● CD4/CD8 ● CAR/TCR positive rate ● RCL (Rapid Test) ● Number of copies ● Sterility (Compendial Method) ● Sterility (Rapid Test) ● Mycoplasma (Compendial Method) ● Mycoplasma (Rapid Test) ● Endotoxin | ||
| 4 | Method Validation | ● Specificity ● Accuracy ● Precision ● Linearity and Range ● LOD | ||
| 5 | Stability Study | ● Long-term stability ● Accelerated stability ● Stress testing ● Shipping stability | ||
*Note: We offer relatively flexible and customized changes to above services, including but not limited to above services.
Advantages
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 CAR-T cell product, which was successfully approved by NMPA • Experience in supporting the technology transfer of clinical batch of CAR-T cell products and in manufacturing of cell samples for clinical use |
Manufacturing process
Quality control
| Types | Test Item | Test Method |
| Routine tests | Appearance | Visual inspection |
| pH | Method 0631 of ChP 2020 | |
| Osmolality | Method 0632 of ChP 2020 | |
| Cellular characteristics/functions | Cell counts | Fluorescence staining |
| Cell viability | Fluorescence staining | |
| CAR positive rate | Flow cytometry | |
| Immune cell composition | Flow cytometry | |
| Cytokine secretion | ELISA | |
| Cytotoxicity | As per Protocol | |
| Impurity | Residual culture supplement | Depending on supplement type |
| Residual magnetic bead count | Microscopy | |
| Safety | Number of CAR gene copies | q-PCR |
| Endotoxin testing | Method 1143 of ChP 2020 | |
| Sterility testing | Rapid testing | |
| Method 1101 of ChP 2020 | ||
| Mycoplasma testing | q-PCR | |
| Method 3301 of ChP 2020 | ||
| RCL | q-PCR |
*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.
Building 4, Yuewang Wisdom Valley, 1463 Wuzhong Avenue, Wuzhong District, Suzhou, China