CDMO Services for CAR-T Cells - Commercial grade
Services
| CDMO Services for CAR-T Cells (HiCellx® Platform) | ||||
| Types | Services | |||
| Commercial grade | 1 | GMP Manufacturing of CAR-T Cells |
● Production scale: 200 mL~20 L (subject to customized changes) ● Process route: flexible process design and subject to customized changes |
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Advantages
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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 |
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| Method 1101 of ChP 2020 | ||
| Mycoplasma testing | q-PCR | |
| Method 3301 of ChP 2020 | ||
| RCL | q-PCR |
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.
