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Hillgene offers end-to-end lentiviral vector CDMO services, delivering high-quality, scalable, and regulatory-compliant solutions for cell and gene therapy developers. From initial plasmid design and vector construction to GMP-grade manufacturing and rigorous quality control testing, our services support your program across all stages. With extensive experience in lentivirus production and a strong focus on viral safety and process consistency, Hillgene ensures:
Accelerated timelines
Flexible batch sizes
Cost-effective production options
Hillgene can provide the following lentiviral vector CDMO services at different stages
We specialize in both research-grade and clinical-grade lentiviral vectors tailored to each client’s needs. Our state-of-the-art facilities support CAR-T, CAR-NK, and other advanced cell therapy applications. As a trusted CDMO partner, Hillgene operates under strict GMP guidelines and aligns with global regulatory standards. Partner with Hillgene to accelerate your gene therapy pipeline with reliable, scalable, and cost-efficient lentiviral vector manufacturing.
Self-adapted third-generation quad plasmid vector system
With traditional VSVG and novel envelope
Completed DMF filing
Virus Expressed 293T serum-free culture technology
Disposable bioreactors
Yield: Up to 2E11TU/50L
Scale: From 10L up to 100L
Different GOI lengths, at a lower MOI, can obtain a high positive rate, low copy number of the cell products
Can be applied to different cells
CAR-T therapy for Solid tumors
TCR-T cell therapeutics
Gene-edited HSCs
UCAR-T cell therapeutics
CAR-NK cell therapeutics
iPS-CAR -NK cell therapeutics
Background
A biotech startup developing dual-target CAR-T therapy for hematological cancers required cGMP-grade lentiviral vector production at 10L scale. The vector needed to carry a 2950bp insert with target specifications of >1E8 TU/mL titer, >50% positivity rate, and VCN<5 copies/cell to support 500 patient doses.
Key Challenge
Large insert size significantly reduced viral packaging efficiency. Maintaining high titer while achieving high transduction efficiency in T-cells proved difficult. The tight 8-month timeline for process development and GMP production added complexity.
Optimization
Implemented high-density culture with optimized transfection reagents
Developed a dual-promoter system to enhance transgene expression
Established a three-step chromatography purification process
Introduced a real-time VCN monitoring and control system
Result
Achieved 1.4E8 TU/mL titer with 53.7% positivity rate
Maintained VCN at 4.1 copies/cell
Completed 3 cGMP batches within 8 months
Single batch yielded 1.6E10 TU, sufficient for 530 patient doses
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Background
A research spin-off needed large-scale lentiviral vector production at 20L scale for off-the-shelf CAR-NK therapy. Requirements included >1E7 TU/mL titer, >40% positivity rate, and VCN<5 copies/cell to support 10 cell production batches.
Key Challenge
Low NK cell transduction efficiency required an exceptionally high viral titer. Scaling to 20L while maintaining consistency and meeting the 5-month timeline for the engineering run was critical.
Optimization
Optimized serum-free suspension culture conditions
Developed specialized transduction enhancers for NK cells
Implemented automated monitoring and control systems
Established rapid quality release protocols
Result
Achieved 3.8E7 TU/mL titer with 43.6% positivity rate
Maintained VCN below 5 copies/cell
Completed engineering run within 5 months
Single batch supported 15 cell production runs
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Background
A clinical-stage company required GMP lentiviral vector production for TCR-T therapy at a 10L scale. Specifications included >5E8 TU/mL titer, >30% positivity rate for 1950bp insert, and VCN<5 copies/cell to treat 80 patients.
Key Challenge
Ultra-high titer requirement combined with the need for precise TCR expression. Tight 7-month timeline for GMP production and stringent regulatory compliance requirements.
Optimization
Developed high-titer packaging cell line
Implemented ultra-filtration concentration technology
Established a comprehensive quality control system
Optimized vector construct for accurate TCR expression
Result
Achieved 6.8E8 TU/mL titer with 36.4% positivity rate
Maintained VCN at 4.5 copies/cell
Completed GMP production within 7 months
Single batch yielded 9.8E10 TU, sufficient for 98 patients
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Background
A university-hospital partnership needed large-scale lentiviral vector production at 100L scale for HSC gene therapy. The 4433bp insert required >2E8 TU/mL titer and VCN >3 copies/cell to treat 250 patients.
Key Challenge
Extremely large insert size near packaging limit. Massive 100L scale production while maintaining quality. The requirement for high VCN in HSCs added complexity.
Optimization
Developed novel capsid proteins for improved packaging
Implemented parallel bioreactor operation strategy
Optimized transduction protocol for HSCs
Established a comprehensive safety testing regimen
Result
Achieved 3.2E8 TU/mL titer despite large insert size
Maintained VCN at 3.6 copies/cell in HSCs
Completed 100L GMP production within 8 months
Single batch yielded 2.8E11 TU, sufficient for 300 patients
At Hillgene, we leverage our advanced serum-free suspension culture GMP platform to provide lentiviral vector CDMO services that meet IND application requirements, with products directly suitable for cell transduction in clinical trials. Our end-to-end process—from vector construction and virus packaging to purification and testing—complies with pharmaceutical regulatory standards. The delivered viral solutions exhibit high titer, high infectivity, and an excellent safety profile (including rigorous RCL testing), ensuring the safe and efficient production of cell-based products such as CAR-T and CAR-NK for clinical trials.
| CDMO Services for Lentiviral Vectors (HiLenti® Platform) | ||||
| Types | Services | |||
| IND grade | 1 | Independently developed four-plasmid system | ● Third generation four-plasmid system ● Granting the license, if required | ● Following standards for submission in both China and US ● Full-GMP workshop ● Separate area for creating cell banks ● Separate workshops within non-sterile and sterile areas ● GMP quality management system |
| 2 | Creation of GMP Cell Bank | ● Tailorable number of cell banks to be created ● Cell bank stability study | ||
| 3 | Process and Test Method Development | ● Following project requirements (subject to customized changes) | ||
| 4 | GMP Manufacturing of Lentiviral Vectors | ● Bioreactor process: 5~50 L disposable bioreactor process (subject to customized changes) ● Production scale: 2~30 L (subject to customized changes) | ||
| 5 | Testing of Lentiviral Vectors | ● Physical titer ● Infective titer ● Functional titer ● Residual 293T host cell DNA testing ● Residual 293T host cell protein testing ● Residual exogenous DNA testing ● Residual Benzonase testing ● E1A/SV40 ● Residual plasmid testing ● DNA fragment size ● Exogenous virokines ● Sterility ● Mycoplasma ● Endotoxin | ||
| 6 | Method Validation | ● Specificity ● Accuracy ● Precision ● Linearity and Range ● LOD | ||
| 7 | Stability Study | ● Long-term stability ● Accelerated stability ● Stress testing | ||
*Note: We offer relatively flexible and customized changes to above services, including but not limited to above services.
Advantages of using our platform for serum-free suspension culturing of lentiviral vectors:
• Free of animal-derived components throughout the process
• Linearly scaled up production of lentiviral vectors
• Using a single container of a 50 L disposable bioreactor
• Cell bank creation in separate workshops
• Dispensing final products using a sterile isolator
• Dedicated lentivirus system for cells, with high infection efficiency
• Low production costs and testing costs (no requirements of testing for BSA and residual pancreatic enzymes)
• Several successful IND submissions to NMPA of lentiviral vectors for cells
| Product | Test Item | Test Method |
| Harvest Fluid | Adventitious virus contamination | Method 3302 of ChP 2020 |
| Replication-competent lentiviruses | Indicator cell culture method | |
| Drug substance/finished product | Appearance | Visual inspection |
| Sterility | Method 1101 of ChP 2020 | |
| Mycoplasma | Method 3301 of ChP 2020 | |
| pH | Method 0631 of ChP 2020 | |
| Osmolality | Method 0632 of ChP 2020 | |
| Target gene structure identification | Sequencing | |
| Residual host cell protein | ELISA | |
| Physical titer (p24) | ELISA | |
| Functional titer | Flow cytometry | |
| Endotoxin | Method 1143 of ChP 2020 | |
| Residual Benzonase | ELISA | |
| Residual host cell DNA | q-PCR | |
| Residual E1A gene transfer | Co-culture method | |
| Residual SV40 gene transfer | Co-culture method |
*Note: Hillgene established QC methods corresponding to different technology platforms, with QC methods including but not limited to above items.
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.
At this stage, Hillgene offers a comprehensively upgraded Clinical-level CDMO solution. Through process scale-up and enhanced quality systems, we ensure stable supply of highly consistent clinical-grade viral materials for Phase II/III clinical trials. This fully meets the medication needs of multi-center trials and diverse patient populations, supporting smooth clinical development. Our entire production process operates in a cGMP environment, adhering to international standards with full traceability. We are committed to ensuring patient safety and trial progress, serving as your trusted partner in clinical development.
| CDMO Services for Lentiviral Vectors (HiLenti® Platform) | ||||
| Types | Services | |||
| Clinical grade | 1 | GMP Manufacturing of Lentiviral Vectors | ● Bioreactor process: 5~50 L disposable bioreactor process (subject to customized changes) ● Production scale: 2~30 L (subject to customized changes) | ● Full-GMP workshop ● Separate workshops within non-sterile and sterile areas ● GMP quality management system ● Validated plant, facility and equipment compliant with clinical requirements |
| 2 | Technology Transfer | ● Technology transfer ● Receiving technology transfer | ● Well-established plan for technology transfer ● Well-established plan for receiving technology transfer ● Plan for transferring different technologies across different phases | |
*Note: We offer relatively flexible and customized changes to above services, including but not limited to above services.
Advantages of using our platform for serum-free suspension culturing of lentiviral vectors:
• Free of animal-derived components throughout the process
• Linearly scaled up production of lentiviral vectors
• Using a single container of a 50 L disposable bioreactor
• Cell bank creation in separate workshops
• Dispensing final products using a sterile isolator
• Dedicated lentivirus system for cells, with high infection efficiency
• Low production costs and testing costs (no requirements of testing for BSA and residual pancreatic enzymes)
• Several successful IND submissions to NMPA of lentiviral vectors for cells
| Product | Test Item | Test Method |
| Harvest Fluid | Adventitious virus contamination | Method 3302 of ChP 2020 |
| Replication-competent lentiviruses | Indicator cell culture method | |
| Drug substance/finished product | Appearance | Visual inspection |
| Sterility | Method 1101 of ChP 2020 | |
| Mycoplasma | Method 3301 of ChP 2020 | |
| pH | Method 0631 of ChP 2020 | |
| Osmolality | Method 0632 of ChP 2020 | |
| Target gene structure identification | Sequencing | |
| Residual host cell protein | ELISA | |
| Physical titer (p24) | ELISA | |
| Functional titer | Flow cytometry | |
| Endotoxin | Method 1143 of ChP 2020 | |
| Residual Benzonase | ELISA | |
| Residual host cell DNA | q-PCR | |
| Residual E1A gene transfer | Co-culture method | |
| Residual SV40 gene transfer | Co-culture method |
*Note: Hillgene established QC methods corresponding to different technology platforms, with QC methods including but not limited to above items.
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.
Looking toward the commercialization of cell therapies, Hillgene has established a Commercial-level lentiviral production platform with high cost-effectiveness and significant production capacity. We focus on addressing two core challenges of the commercialization stage: cost reduction and stable supply. Through continuous process optimization and smart manufacturing, we achieve large-scale (thousands of liters), low-cost, high-titer lentiviral vector production. Every batch strictly complies with global regulatory requirements.
| CDMO Services for Lentiviral Vectors (HiLenti® Platform) | ||||
| Types | Services | |||
| Commercial grade | 1 | GMP Manufacturing of Lentiviral Vectors | ● Bioreactor process: 5~50 L disposable bioreactor process (subject to customized changes) ● Production scale: 2~30 L (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 platform for serum-free suspension culturing of lentiviral vectors:
• Free of animal-derived components throughout the process
• Linearly scaled up production of lentiviral vectors
• Using a single container of a 50 L disposable bioreactor
• Cell bank creation in separate workshops
• Dispensing final products using a sterile isolator
• Dedicated lentivirus system for cells, with high infection efficiency
• Low production costs and testing costs (no requirements of testing for BSA and residual pancreatic enzymes)
• Several successful IND submissions to NMPA of lentiviral vectors for cells
| Product | Test Item | Test Method |
| Harvest Fluid | Adventitious virus contamination | Method 3302 of ChP 2020 |
| Replication-competent lentiviruses | Indicator cell culture method | |
| Drug substance/finished product | Appearance | Visual inspection |
| Sterility | Method 1101 of ChP 2020 | |
| Mycoplasma | Method 3301 of ChP 2020 | |
| pH | Method 0631 of ChP 2020 | |
| Osmolality | Method 0632 of ChP 2020 | |
| Target gene structure identification | Sequencing | |
| Residual host cell protein | ELISA | |
| Physical titer (p24) | ELISA | |
| Functional titer | Flow cytometry | |
| Endotoxin | Method 1143 of ChP 2020 | |
| Residual Benzonase | ELISA | |
| Residual host cell DNA | q-PCR | |
| Residual E1A gene transfer | Co-culture method | |
| Residual SV40 gene transfer | Co-culture method |
*Note: Hillgene established QC methods corresponding to different technology platforms, with QC methods including but not limited to above items.
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.
86 198 5711 6962 
info@hillgene.com 
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