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The field of viral vector treatments is expanding at a rate never seen before thanks to innovative uses in precision medicine, gene therapy, and cancer treatment. With the worldwide market expected to grow at a compound annual growth rate (CAGR) of 27.36% to $4.19 billion by 2029, our state-of-the-art solutions put you at the forefront of this innovative industry.

Creative Biogene is a biotechnology leader committed to creating scientific discoveries through cutting-edge viral vector technologies. Creative Biogene's objective is to close the gap between pioneering research and life-changing therapies by providing creative technical solutions, stringent quality control, and personalized services. With a decade of experience servicing the pharmaceutical and biotechnology sectors, we offer specialized assistance for foundational research, translational medicine, and drug development, allowing our clients to speed the route from concept to clinical application.

Service Highlights

1 Advanced Technology

Proprietary viral vector design platform enabling high-efficiency production. Achieves 10⁸ to 10⁹ TU/ml titers without concentration, supporting both research and large-scale applications.

2 High Quality & Assurance

BSL-2 facility-based virus generation following NIH guidelines. Rigorous GMP-standard quality control ensuring viral vector safety, stability, and efficacy.

3 Quick Turnaround

Streamlined, standardized viral packaging production line guaranteeing efficient project completion.

4 Customized Solutions

Comprehensive service offering including plasmid amplification, custom vector construction, and large-scale production. Provides end-to-end technical support tailored to research and therapeutic needs.

Main Service Categories

Viral Vector Services

These vectors are pivotal tools for precise genome editing, optimized gene expression, and producing high-quality viral particles.

Comparison of Adenovirus, AAV, Retrovirus, and Lentivirus for Gene Delivery

FeaturesAdenovirusAAVLentivirusRetrovirus
GenomedsDNAssDNAssRNAssRNA
Infect Dividing CellsYesYesYesYes
Infect Non-dividing CellsYesYesYesNo
Genomic IntegrationNoYes/NoYes/NoYes
Expression Pattern10 days to months2.5–6.0 months>12 monthsDays to months
Expression LevelHighModerateModerateModerate
Cloning Capacity8-30 kb3.5–4.0 kb7–8 kb7–8 kb
Immune ResponseHighVery lowLowModerate
Viral TiterHighModerateModerateModerate
Transduction EfficiencyHighModerateModerateModerate

Research and Production Tool Viral Systems

Creative Biogene offers both standalone and integrated services, streamlining the process from viral component validation to virus packaging, with GMP production support, saving time and costs while ensuring effectiveness.

Other Special Viral Systems

Creative Biogene also offers specialized viral services, including rabies, vaccinia, vesicular stomatitis, baculovirus, and herpes simplex viruses.

Client Case Studies & Research Outcomes

Creative Biogene provides tailored viral services to promote cancer research, vaccine development, and gene therapy, allowing researchers to quickly investigate molecular pathways and generate novel therapeutics.

Case Study 1

Breast cancer stem cells (bCSCs) play an important role in tumor growth and resistance to therapy. The researchers used miRNA gain- and loss-of-function screens to study the molecular processes governing bCSC behavior. They identified that silencing miR-600 leads to bCSC expansion, while its overexpression reduces self-renewal and tumorigenicity. miR-600 targets SCD1, an enzyme necessary for WNT protein activation. This regulation affects bCSC differentiation and WNT signaling. In their study, the researchers utilized our custom viral services, using lentiviruses to deliver miR-600-modulating constructs into breast cancer cells.

Figure 1:Tumor development kinetics, bCSC frequency analysis, and the experimental technique for lentiviral infection of patient-derived xenograft cells in NOD/SCID mice are shown in Figure 1. (doi:10.1016/j.celrep.2017.02.016)Figure 1. The researchers employed lentiviral infection to introduce Lenti-CTRL, Lenti-miR-600, or Lenti-sponge 600 into cells taken from patient xenografts. They implanted FACS-sorted DsRed-positive cells in NOD/SCID mice, followed tumor development kinetics, and examined bCSC frequency using an extreme limiting dilution approach. (El Helou R, et al., 2017)

Case Study 2

As demonstrated by the effectiveness of mRNA vaccines, ionizable cationic lipid-containing lipid nanoparticles (LNPs) are crucial for non-viral gene delivery. The scientists created a chemical library of ionizable cationic lipids using a one-step enzyme-catalyzed esterification process. These lipids were then formulated into LNPs for efficient mRNA delivery. Through rigorous screening and optimization, the AA3-DLin LNPs demonstrated exceptional mRNA delivery efficiency and stability. The researchers utilized these LNPs in a COVID-19 vaccine model, showing strong immunogenic responses in mice. The SARS-CoV-2 pseudovirus used in this study was constructed by Creative Biogene.

Figure 2: The immunogenicity of AA3-DLin COVID-19 vaccines is depicted in Figure 2, which includes comparisons with different LNP formulations, protein expression, immunogenic responses, and experimental design. (doi:10.1021/acsnano.2c07822)Figure 2. The researchers used a SARS-CoV-2 pseudovirus neutralization experiment, incubating the luciferase-expressing pseudovirus with serially diluted serum samples. After incubation, the virus was added to ACE2-293T cells, and luciferase activity was measured to determine the neutralization of IC50 titers. (Li Z, et al., 2022)

Case Study 3

The receptor tyrosine kinase Ephrin receptor A10 (EphA10) is associated with tumor growth and a poor prognosis, especially in triple-negative breast cancer. The researchers created a lentiviral expression system for EphA10 using our specialized viral services. By transfecting cells with the EphA10 CAT vector and lentiviral packaging plasmids, they successfully established stable cell lines for studying EphA10 expression and its role in tumor biology.

Figure 3: The creation, binding specificity, activation, cytotoxicity, and tumor regression of EphA10-specific CAR-T cells in a mouse model are detailed in Figure 3, along with their validation and in vivo effectiveness in preventing TNBC development. (doi:10.1016/j.jbc.2022.101817)Figure 3. To target TNBC, the researchers used lentiviral vectors to create EphA10-specific CAR-T cells. Creative Biogene supplied the lentiviral packaging plasmids (LentiArt pHelp1, LentiArt pHelp2, and LentiArt pHelp3). (Cha JH, et al., 2022).

Quality Assurance Program

Our rigorous quality assurance method is intended to assure the greatest levels of purity, potency, and safety for our products. This comprehensive method includes a range of advanced testing processes required to meet regulatory standards and ensure product consistency throughout development.

1. Purity Control

  • Protein Impurities: Bradford assay, BCA protein analysis, ELISA.
  • Nucleic Acid Impurities: qPCR to detect residual host cell DNA and plasmid DNA (<10 ng).
  • Viral Integrity: Electron microscopy (EM), Dynamic Light Scattering (DLS).
  • Endotoxins: Limulus Amebocyte Lysate (LAL) Assay.

2. Potency Assessment

  • Functional Titer: Gene expression via fluorescent markers, qPCR, or ddPCR.
  • Physical Titer: RNA, p24 protein, reverse transcriptase quantification.
  • Genome Integrity: qPCR for integration.

3. Safety Testing

  • RCL Testing: To ensure the absence of replication-competent lentivirus (RCL).
  • Other Safety Tests: Adventitious agents, endotoxins, mycoplasma, sterility.
  • Cytotoxicity: MTT assay and LDH release assay.

4. Identification and Characterization

  • Vector Characterization: Sequencing, restriction enzyme mapping, Western blot, SDS-PAGE.
  • Immunogenicity: Reverse-phase HPLC, ELISA, cytokine assays, mouse models.

5. Stability Testing

  • Temperature & Long-Term Storage Stability: Evaluation under different conditions.

Service Support

Documentation

Our well-organized document management system ensures that we provide all necessary documentation to support your project.

  • Detailed batch records
  • Analytical certificates
  • Regulatory documentation
  • Storage and handling guidelines

Contact Us

As your valued partner, we recognize that each project is unique. Our expert staff collaborates directly with you, providing optimal solutions at every stage from design to completion. 

  • Customized vector design for your individual needs.
  • Scalable production procedures enable project growth.
  • Expert regulatory guidance to overcome compliance challenges.
  • Continuous project management support during development.

Choosing us means not just getting superior viral vector technology, but also having a long-term partner who is committed to pushing scientific development. Contact our specialists now to find out how our cutting-edge solutions can help your study!

FAQ

Q1: Retroviruses may cause transcriptional read-through (TRT) during transcription. Does this mean that the use of retroviruses in gene therapy is highly uncertain? Are there any technologies or methods to reduce this risk?

A1: Indeed, the issue of transcriptional read-through in retroviruses is a potential risk, particularly when used over extended periods or multiple times, which may lead to unintended gene expression. To address this, we currently implement additional genetic engineering designs to limit TRT risks when using retroviruses. For instance, by optimizing the viral vector promoters or improving transcription control mechanisms, we ensure more precise gene expression. These improvements significantly reduce the possibility of mutagenic risks.

Q2: How does Creative Biogene ensure packaging efficiency and purity of viral vectors during the production process?

A2: During viral vector production, Creative Biogene utilizes efficient packaging systems and rigorous quality control procedures. We employ specialized packaging cell lines along with optimized transfection methods to ensure high yield and purity for each batch. Every production step, including virus concentration, purification, and testing, is carefully controlled to meet the quality standards required by our clients.

Q3: Does Creative Biogene offer cell line customization or optimization services to improve transduction efficiency for specific viral vectors?

A3: Yes, Creative Biogene offers cell line customization and optimization services. Based on the client’s experimental requirements, we can optimize viral vector production and transduction efficiency by selecting the most suitable cell line or optimizing existing ones to enhance transduction efficacy and the reliability of experiments.

Q4: Does Creative Biogene use stable packaging cell lines during viral vector production? What advantages do these cell lines offer in viral production?

A4: We use stable packaging cell lines for viral vector production. These cell lines are rigorously selected to consistently and stably produce high-titer viral vectors, minimizing production variability and ensuring consistent quality. Stable packing cell lines increase production efficiency and decrease the risk of inconsistency, ensuring that customers obtain high-quality products.

Q5: Can Creative Biogene provide bulk production solutions for viral vector packaging, and how do they maintain consistency across multiple production scales?

A5: Yes, Creative Biogene offers mass manufacturing options for viral vector packaging. We can scale from tiny laboratory-scale production to large-scale manufacturing to meet the demands of our clients. We maintain great consistency in each batch, whether produced on a small or big scale, by continuously optimizing processes, using automated equipment, and implementing tight quality control systems.

* For research use only. Not intended for any clinical use.
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