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Lentiviral vectors (LVs) have become a cornerstone in gene and cell therapy (CGT) due to their ability to efficiently infect both dividing and non-dividing cells, provide stable long-term expression, and offer relatively safe integration profiles. They are widely used in approved therapies such as Kymriah and Zynteglo, as well as in numerous clinical trials for CAR-T cell therapy, hematopoietic stem cell modification, rare genetic disorders, solid tumors, and vaccine development. As regulatory standards tighten and demand increases, the need for GMP-grade LVs with high titer, purity, and consistency has become critical.
Creative Biogene has established a robust viral production platform based on extensive experience in lentiviral process development and GMP manufacturing. We offer comprehensive end-to-end services, spanning plasmid design and cell line screening through to upstream production, purification, and quality control, supporting both in vivo and ex vivo clinical applications.
1 Dedicated GMP-Compliant Facility
Cleanrooms with independent zones for microbiology, cell culture, and viral handling, fully compliant with FDA/EMA GMP standards.
2 Optimized Upstream Process
HEK293 suspension-adapted cells, high-density culture systems, and efficient PEI transfection allow scalable high-titer LV production (>100L).
3 High-Yield Purification
Combination of tangential flow filtration (TFF) and dual chromatography (AEX + Heparin affinity) ensures >90% virus recovery and high impurity clearance.
4 Comprehensive GMP Quality System
Covers raw materials, equipment, SOPs, personnel training, and documentation to ensure product safety, consistency, and traceability.
5 Flexible Customization
Supports tech transfer, IND documentation, and clinical acceleration strategies for rapid bench-to-bedside transition.
To ensure consistent, scalable, and regulatory-compliant GMP lentiviral vector manufacturing, Creative Biogene has established an end-to-end production workflow. This includes plasmid construction, upstream bioreactor-based production, downstream purification, and robust formulation for clinical readiness.
Efficient and safe lentiviral production begins with the construction of high-quality plasmids using a third-generation four-plasmid system. This configuration reduces the risk of replication-competent lentivirus (RCL) formation and meets global regulatory expectations.
High-yield lentivirus production requires robust packaging cell performance. We offer scalable upstream solutions using optimized cell lines and flexible transfection technologies.
Lentiviral vector yield and consistency are heavily influenced by bioreactor design and process parameters. Our flexible bioreactor platform enables scalable and controlled vector production.
Our purification workflow is optimized for high virus recovery and purity while preserving bioactivity. All processes are developed under GMP and designed for scalability and regulatory alignment.
| Step | Method | Highlights |
| Clarification | Depth filtration + TFF | Removes cellular debris and aggregates while maintaining viral integrity. |
| Concentration | Tangential Flow Filtration (TFF) | Achieves up to 100x volume reduction with minimal vector loss. |
| Chromatography | Anion exchange (AEX) + Heparin affinity | Ensures removal of host cell proteins, plasmid DNA, and process impurities, reaching >95% purity. |
| Buffer Exchange | TFF or Size-Exclusion Chromatography (SEC) | Final formulation buffer adjustment to optimize virus stability and storage. |
Stability and usability of the lentiviral product are ensured through custom formulation and validated cold chain logistics.
Each GMP lentiviral vector batch is subject to a comprehensive QC program covering identity, potency, purity, and safety, in alignment with ICH Q5A, USP<1046>, Ph. Eur., and FDA guidelines.
| Test Type | Parameter | Method | Specification |
| Physicochemical | pH, Osmolality | USP<791>, USP<785> | pH 7.0–8.0; 260–350 mOsm/kg |
| Potency | Infectious titer (TU/mL) | qPCR or flow cytometry | ≥1×10⁸ TU/mL |
| Identity | Transgene confirmation | Sanger sequencing, qPCR | 100% match with the design sequence |
| Protein Expression | P24 antigen, GOI protein | Western blot, ELISA | Comparable to the reference standard |
| Sterility & Safety | Sterility, Mycoplasma, Endotoxin, RCL, Adventitious agents | USP<71>, qPCR, LAL, in vitro/in vivo | Negative; endotoxin ≤10 EU/mL |
| Purity | Host cell DNA, residual plasmid DNA, BSA, Benzonase, SV40 Large T | qPCR, ELISA, Southern blot | Within specification (<10 ng/dose DNA, <10 ppm protein) |
| Service Tier | Application Stage | Scale (Final Volume) | Typical Titer (TU/mL) | Quality Grade | Get Pricing Information |
| Pilot Scale | Preclinical Studies | 1 – 10 L | 5×10⁷ – 1×10⁸ | GMP-like | Inquiry |
| GMP Demo Batch | IND-Enabling | 5 – 20 L | ≥1×10⁸ | GMP-compliant | Inquiry |
| GMP Clinical Batch | Phase I/II Clinical Trials | 20 – 100 L | ≥1×10⁸ | Full GMP | Inquiry |
| Commercial Scale | Phase III / Commercial | >100 L (customizable) | ≥1×10⁸ | Full GMP | Inquiry |
As CGT development accelerates alongside evolving regulatory landscapes, the demand for clinical-grade lentiviral vectors remains strong. Creative Biogene remains committed to providing safe, scalable, and high-quality LV production through our advanced platform, rigorous GMP system, and expert support team. We help our partners transform gene therapy from bench to bedside. Contact us today for a customized service proposal and technical consultation.
Q1: Do you provide plasmids for clinical use?
Yes, we offer both research-grade and GMP-grade plasmids tailored to your vector design.
Q2: How do you ensure GMP compliance during production?
Our facility operates under a comprehensive GMP quality system with controlled environments, qualified personnel, validated processes, and thorough documentation.
Q3: What is the typical turnaround time for GMP lentivirus production?
Depending on the scope and customization, typical timelines range from 3 to 5 months.
Q4: Can you assist with IND filing and regulatory consultation?
Absolutely. We provide regulatory writing support, CMC documentation, and consultation services.
Q5: What titers can I expect from your production?
Our optimized platform routinely delivers infectious titers ≥1×10^8 TU/mL.
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