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In today's era, where gene therapy and cell-based medicines are advancing rapidly toward clinical applications, the core challenge facing research institutions and biotechnology companies is how to achieve safe, efficient, and controllable gene delivery. Creative Biogene's Integrase-deficient Lentivirus (IDLV) service is specifically designed for applications requiring high expression levels, enhanced safety, and avoidance of permanent genomic modification. It has become the preferred solution for numerous cutting-edge gene delivery projects.
IDLV introduces mutations at critical sites of integrase (such as D64V, D167H) or long terminal repeat (LTR) attachment sites (att), rendering the virus incapable of integrating foreign DNA into the host genome. Instead, it exists as circular episomes within the cell nucleus. This design not only maximally reduces gene toxicity and safety hazards caused by insertional mutagenesis but also enables efficient transient expression of transgenes. IDLV demonstrates exceptional flexibility and advantages in applications that do not require long-term expression, including gene editing, vaccine development, cell programming, and preclinical functional validation.
Compared to traditional integrating lentiviral vectors (IPLV), IDLV significantly reduces the potential risk of insertional mutagenesis, making it particularly suitable for stem cells, primary cells, neurons, and other scenarios with extremely high requirements for genetic stability. We provide high-quality testing services that comply with industry standards, including those of the FDA and EMA, supporting preclinical applications and IND regulatory compliance.
Gene Editing
Suitable for short-term expression of Cas9/gRNA systems, reducing off-target risks, especially ideal for high-throughput screening, cell line construction, and iPSC manipulation.
Vaccine Development
IDLV has been widely used for delivering coding sequences of HIV, HCV, influenza, tumor antigens, etc., achieving potent and durable immune responses with promising applications in cancer vaccine development.
Cell Therapy
Suitable for preconditioning and safety regulation of CAR-T, CAR-NK cells, including delivery of suicide gene systems for cell elimination mechanisms.
Cell Reprogramming
Integration-free Yamanaka factor expression system, serving as an ideal tool for cell reprogramming and organ regeneration research.
Gene Therapy Validation
Has achieved transient expression of functional proteins in models of hemophilia, inherited retinal diseases, etc., providing safe means for therapeutic mechanism research and preliminary validation.
Our GMP-compliant process system features a fully controlled, fourth-generation lentiviral packaging platform that enhances both safety and expression efficiency by distributing viral core elements across four separate plasmids (pGag/Pol-INmut, pRev, pVSV-G, and the transfer plasmid). Utilizing a 293T co-transfection expression system with either calcium phosphate or PEI, viral supernatants are harvested at 48 and 96 hours, followed by TFF purification and Mustang Q chromatography for effective impurity removal.
By international biological product regulations, we have established a comprehensive quality control system for IDLV vectors:
| Category | Test Item | Method | Acceptance Criteria |
| Physicochemical | pH | pH meter | 7.2 – 7.4 |
| Protein concentration | BCA assay | Within the client-specified range | |
| Protein impurities | SDS-PAGE (silver staining) | No visible non-specific bands | |
| Endotoxin | LAL assay (Limulus Amebocyte Lysate) | ≤ 50 EU/mL | |
| Bioactivity | Functional titer | qPCR / FACS | ≥ 2 × 10⁸ TU/mL (depending on the vector) |
| Transduction efficiency | Flow cytometry/fluorescence microscopy | Significantly higher expression than the control | |
| Microbiological | Sterility | Plate culture (bacteria/fungi) | Negative |
| Mycoplasma | PCR / Fluorescent staining | Negative | |
| Purity-Related | RNA contamination | Nanodrop ratio/gel electrophoresis | 260/280 ratio between 1.8 and 2.0 |
| Host cell protein (HCP) | ELISA | ≤ 100 ng/mL (customizable upon request) | |
| Host cell DNA | PicoGreen fluorescent staining | ≤ 10 ng/dose (clinical-grade standard) | |
| Safety | Replication Competency | Indicator cell culture / qPCR / ELISA / PERT | Negative |
Note: Supports custom production from small volumes (<1 mL) to large batches (>100 mL), accommodating different experimental scenarios and budget requirements.
Creative Biogene is committed to providing high-quality gene delivery solutions for research and industrial clients. We understand the refined requirements different projects have for viruses and look forward to partnering with you. From design to delivery, we empower your gene therapy, vaccine development, cell engineering, and other critical research endeavors!
Q1: Can IDLV be used for gene delivery in non-dividing cells, such as neurons?
A1: Yes, IDLV is particularly suitable for non-dividing cells such as neurons and hepatocytes. Its long-term expression capability and low immune response make it an ideal choice for research in fields like neurodegenerative diseases.
Q2: Does IDLV have any negative impact on cell function?
A2: Due to its non-integrating nature, IDLV does not alter the host cell genome, meaning it does not cause long-term functional impairments in cells. It exists as an episome and only provides short-term expression, effectively avoiding phenotype changes caused by gene integration.
Q3: How is the quality of IDLV ensured?
A3: Each batch of IDLV undergoes rigorous quality control testing, including titer determination, purity analysis, sterility testing, and endotoxin checks. We use advanced testing technologies to ensure the high quality and safety of the viral vector.
Q4: Can integrase-deficient lentiviral vectors be customized?
A4: Yes, we offer custom services to help clients design vectors based on their specific research needs, including the selection of different promoters, reporter genes, and tag proteins. We provide the best vector construction plans tailored to your experimental requirements.
Q5: What are the advantages of IDLV compared to traditional lentivirus?
A5: The major advantage of IDLV is its inability to integrate into the genome, thus avoiding insertional mutagenesis and genetic toxicity risks, making it ideal for high-precision gene editing applications. Additionally, IDLV allows efficient transient expression in both dividing and non-dividing cells, with a large gene packaging capacity. Comparison of Viral Vectors:
| Characteristic | IDLV | Traditional Lentivirus | AAV | Adenovirus | Herpes Simplex Virus |
| Genome Type | RNA | RNA | ssDNA | dsDNA | dsDNA |
| Infects Cell Types | Dividing/Non-dividing | Dividing/Non-dividing | Dependent on serotype | Primary/Various | Neurons/Various |
| Infection Efficiency | Medium | Medium | Medium | High | Medium |
| Expression Duration | Transient/Partial | Stable Integration Expression | Transient/Partial Stable | Transient | Transient |
| Integration | No | Yes | No | No | No |
| Vector Packaging Capacity | >8 kb | >8 kb | <4.7 kb | >8 kb | Up to 150 kb |
| Immunogenicity | Low | Low | Low | High | High |
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