Virus vector is the most commonly used gene delivery system for cell and gene therapy at present. Among them, Lentivirus vector is the commonly used carrier for CAR-T drugs, and AAV is also directly used for human body as a gene drug. A good virus carrier needs to meet the requirements of higher infection efficiency, better safety, and large-scale GMP production.
Lishan Biotech GMP Virus Vector Preparation Center includes several independent GMP virus production lines. The center is equipped with the industry's mainstream large-scale production line of virus vectors, which can provide one-stop CDMO services for GMP Lentivirus and GMP AAV. The center has two filling solutions, B+A and C+A (isolators), to meet diverse process requirements.
| Service category | Service content |
| Cell library building | Establishment of cell strain library Third level cell bank supply Third level cell bank preservation |
| Virus Upstream Process Development | Optimization of Cell Culture Conditions Optimization of adherent/suspension cell line culture Development and optimization of virus packaging technology |
| Downstream process development of viruses | Nuclease treatment conditions Concentration filter membrane pore size and concentration factor Ultrafiltration concentration and liquid replacement method |
| Methodology Development | Development of quality research methods Study on the stability of virus vector Complies with the regulations of the Chinese and American |
| Document preparation | Product Inspection Report (CoA) Batch production and inspection records Process development report, stability study, etc |
Classification detection items | Testing items | Test method | Quality standard |
|---|---|---|---|
General inspection items | Aappearance | Visual inspection method | Clarifying liquid |
| pH | pH meter | 7.3±0.5 | |
Osmotic pressure | Freezing point detection method | 300~500mmol/kg | |
Identify | CAR gene identification | Sanger sequencing method | Conforming to sequence |
Vitality | Infection titer | Flow type | ≥1x108TU/mL |
Physical titer | P24 ELISA | 1-4×107pg/ml | |
Purity | BSA residue | ELISA | <200ng/ml |
HCP residue | ELISA | <1ug/1×108 TU | |
HCD residue | qPCR | <50pg/ml | |
Nuclease residue | ELISA | <0.5ng/ml | |
Plasmid DNA residue | qPCR | <1ng/μl | |
| SV40 | qPCR | <200copies/ul | |
| E1A | qPCR | <500copies/ul | |
Security item | Endotoxin | LAL | <10EU/ml |
Rapid mycoplasma | qPCR | not detected | |
Rapid aseptic | qPCR | negative | |
Sterility test | Cultivation method | negative | |
Mycoplasma detection | Cultivation method | not detected | |
RCL detection | Cultivation method /qPCR/P24 ELISA | not detected |
Tel：0531-58629111
PostCode：cdmo@lishanbio.com
Address：No. 4577 Jingshi Road, Lixia District, Jinan City, Shandong Province
SCAN
