Viral Vector Purity Detection Introduction
Viral vectors, such as Adeno-Associated Virus (AAV), Lentivirus (LV), and Adenovirus (AdV), are complex biological products produced in living cells. Consequently, the final product often contains various impurities derived from the production process (process-related) or the product itself (product-related). Purity detection is a mandatory step in quality control (QC) to minimize immunogenicity and ensure clinical safety.
It's crucial to ensure the purity of the viral vector before its use in both preclinical and clinical trials.
These impurities encompass various factors, including:
Host Cell Protein (HCP)
HCP is a significant impurity in viral vector manufacturing, posing a primary risk of immunogenicity.
Nucleases
Nucleases can be introduced in the process of removing plasmid DNA and host DNA.
Process-Related Residues
Specific process-related residues, such as BSA, PEI, helper virus, and residues from decontaminants.
Our Platform Advantages
Why Choose Our Platform?
High-Resolution Technologies
Utilizing gold-standard methods (AUC, Cryo-EM) and high-throughput HPLC/CE.
Most accurate assessment of capsid loading.
Innovative Research and Development
We are dedicated to continuous research and adapting methodologies to meet industry advancements.
Discover new applications and enhance product efficacy.
Customized Assay Development
Tailored for specific serotypes and manufacturing platforms (HEK293 vs Sf9).
Detects process-specific impurities.
Purity Detection Services Overview
We offer a modular approach to purity testing, allowing clients to select specific assays or a comprehensive panel depending on their development stage.
Empty/Full Capsid
Quantify the ratio of empty, partial, and full capsids to ensure product efficacy using orthogonal methods.
- Analytical Ultracentrifugation (AUC)
- Cryo-Electron Microscopy
- Anion Exchange HPLC
Host Impurities
Sensitive detection of residual proteins (HCP) and DNA (HCD) from HEK293, Sf9, or HeLa lines.
- Process-Specific ELISA
- LC-MS/MS Proteomics
- qPCR & ddPCR
Aggregation
Identify high molecular weight aggregates and sub-visible particles that trigger immune responses.
- SEC-MALS Analysis
- Dynamic Light Scattering (DLS)
- Nanoparticle Tracking (NTA)
Ensuring the absence of adventitious agents and biological contaminants for clinical safety.
- Endotoxin (LAL)
- Sterility & Mycoplasma
- Residual Reagents
Comparison of Detection Methods
Selecting the right method depends on the required sensitivity, throughput, and development phase.
| Target Impurity | Primary Method | Key Advantages |
|---|---|---|
| Empty Capsids | Analytical Ultracentrifugation (AUC) | Matrix-free, high resolution, serotype independent. |
| Host Cell Proteins (HCP) | ELISA / LC-MS/MS | ELISA for high throughput; LC-MS for identification of specific immunogenic proteins. |
| Host Cell DNA (HCD) | qPCR / ddPCR | Highly sensitive quantification; ddPCR offers absolute quantification without standard curves. |
| Aggregates | SEC-MALS | Determines absolute molecular weight and oligomeric state. |
Customized Testing Solutions
Customized Testing Panels
- Tailored for HEK293 & Sf9 platforms
- Compliant with ICH Q2(R1) guidelines
- Fast turnaround for research phases
Ready to test?
Response within 24 hoursSupported Viral Vector Types
Customized detection programs tailored to the unique characteristics of each vector type.
Adeno-Associated Virus (AAV)
AAV is the most widely used vector in gene therapy. Purity detection critically focuses on the Full/Empty Capsid Ratio, capsid protein integrity, and the presence of aggregates.
Supported Serotypes:
We cover all common naturally occurring and synthetic serotypes, including but not limited to AAV1, AAV2, AAV5, AAV6, AAV8, AAV9, AAV-rh10, and engineered capsids like AAV-PHP.B/eB.
Lentivirus (LV)
Extensively used in cell therapies such as CAR-T and TCR-T.
Key Purity Concerns:
- Residual p24 antigen detection
- Host cell residual DNA/Protein (HCD/HCP)
- Residual packaging components
Adenovirus (AdV)
Commonly used as a vaccine or in vivo gene therapy vector.
Other Advanced Vectors
Retrovirus & HSV
Comprehensive purity and safety profiling for Herpes Simplex Virus and Retrovirus.
Oncolytic Viruses (OVs)
Targeted analysis ensuring oncolytic potency and purity.
mRNA-Lipid Nanoparticle (LNP)
Impurity analysis including PEGylated lipids, residual solvents, and free mRNA.
Service Workflow
Sample Submission
Submit samples & Feasibility
Method Optimization
Qualification & Testing
Data Analysis
QC Analysis & Reporting
Client submits viral vector samples and process information. Our team evaluates the sample matrix and concentration to recommend the most suitable purity assays.
For complex matrices, we perform method qualification or optimization. Samples are then tested using selected technologies (e.g., AUC, ELISA, qPCR) with appropriate controls.
Raw data is analyzed by our QC team. A comprehensive report including chromatograms, images, impurity calculations, and a Certificate of Analysis (CoA) is delivered.
Client Testimonials
Dr. H. Lee
Director of CMC
"The AUC data provided by Creative Biolabs gave us definitive proof of our downstream purification efficiency. Their ability to accurately quantify empty vs. full capsids was pivotal for our FDA IND submission."
Sarah M.
Senior Scientist
"We struggled with consistent HCP detection using generic kits. Creative Biolabs developed a process-specific ELISA for our HEK293 platform that drastically improved our impurity tracking. Highly recommended."
Frequently Asked Questions
Typically, we require at least 400 µL of sample at a concentration of >1E12 vg/mL. However, low-volume cells are available for scarce samples. Please contact us for specific requirements based on your serotype.
Yes. Analytical Ultracentrifugation (AUC) is capable of resolving empty, partially filled, and full capsids based on their sedimentation coefficients.
Yes, we offer cGMP-compliant release testing services suitable for clinical and commercial batch release.
Our qPCR and ddPCR methods can detect residual host cell DNA at picogram levels, well below the regulatory limit of 10 ng/dose.
Connect with Us for Viral Vector Quality Control
Creative Biolabs provides robust purity detection solutions to accelerate your gene therapy program. Contact us today to discuss your testing needs and receive a customized proposal.
Our technical support team is available 24 hours a day!
Tell us about your project, and our experts will get back to you with a customized quote and proposal.
