Leverage uBriGene’s expertise in viral vector analytical development, assay validation, and final product release to ensure superior quality and compliance.
As a leading viral vector CDMO, uBriGene has successfully manufactured and released over 60 batches of viral vectors, including AAV, LVV, adenovirus, and oncolytic viruses. Partner with our experienced viral vector analytics team to ensure the quality and safety of your cell and gene therapy products.
Ensure the safety, quality, and regulatory compliance of your viral vector products with uBriGene’s expert analytical development and QC testing services.
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60+ GMP viral vector batches successfully delivered
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The uBriGene team has validated a comprehensive suite of assays for LVV analytics, supporting both process development and final product lot release. Additionally, our analytics development team collaborates with clients to develop and validate custom product-specific assays. We also routinely perform tech transfers for assay methods not offered in-house but preferred by our clients.
Analytical and QC testing categories for lentivirus:
The uBriGene team has a rich history supporting AAV clinical trials for programs focused on diseases of the eye, CNS, and blood. As a result of that extensive experience, we have developed an impressive collection of orthogonal assays for addressing the multiple challenges of consistently producing and characterizing high quality and high titer AAV drug products. This includes robust assays for the critical, but often challenging, quantitative assessment of empty/full capsid ratios.
Analytical and QC testing categories for AAV:
Quality control (QC) testing is a critical component in the production of adenoviral vectors to ensure they meet rigorous safety, efficacy, and regulatory standards. Comprehensive QC testing evaluates key attributes such as identity, potency, purity, and stability, ensuring the adenovirus product is suitable for clinical and commercial use. Below is a list of essential assays used in adenovirus QC testing to guarantee consistent product quality and therapeutic success.
Analytical and QC testing categories for adenovirus:
Safety: Endotoxin, sterility, mycoplasma
The uBriGene team has a track record of success manufacturing a variety of oncolytic viral vectors, including vaccinia virus. The testing of these vectors requires rigorous quantitative assessment of the potency and specificity of tumor cell killing. The uBriGene team has the established expertise to efficiently design, validate, and execute those important functional tests.
Analytical and QC testing categories for oncolytic viruses:
AAV is known to assemble empty capsids during production, which can impact efficacy and increase immunogenicity. Accurate full/empty ratio testing is critical for AAV drug products.
The current gold standard for empty/full ratio testing is analytical ultracentrifugation (AUC), which provides comprehensive information on the components of AAV products, including the percentages of aggregates, full, partial, and empty capsids.
Figure 1. AUC analysis of AAV full/empty capsid ratio.
The infectious titer or transduction titer is often much lower than the genomic titer. Therefore, infectious/transduction titer testing is a critical QC assay for the release of GMP-grade lentiviral vector batches.
Two main methods are commonly used, depending on the application and required sensitivity. The first is an integration and qPCR-based method that measures genomic integration after transducing cells with the lentiviral vector. The second is a functional titration, protein expression-based method. For CAR-T applications, flow cytometry is typically employed, using antibody staining to detect the expressed CAR after lentiviral vector transduction.
Figure 2. Transduction titration of lentiviral vectors after transducing Jurkat cells. Lentiviral vectors encoding six different genes were manufactured using uBriGene’s suspension cell line, 293TH. Flow cytometry was used to detect LVV-transduced cells, and the transduction titer was calculated.
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Common methods for assessing AAV empty/full capsid ratios include OD260/280, transmission electron microscopy (TEM), analytical ultracentrifugation (AUC), and HPLC. AUC is uBriGene’s preferred release-testing method because it quantitatively distinguishes empty, partial, and full capsids based on sedimentation, without labels or stains. The full-particle ratio of uBriGene-manufactured AAV typically ranges from 80% to 95%, depending on serotype.
Yes. uBriGene performs the AAV TCID50 assay to measure infectious titer using HeLa RC32 cells in 96-well plates and serially diluted AAV samples. After incubation, qPCR with gene-of-interest-specific primers identifies positive wells. TCID50 is calculated using the Reed–Muench or Spearman–Kärber method based on the proportion of infected wells.
A replication-competent AAV (rcAAV) assay detects replication-competent contaminants in AAV preparations. Testing may use cell-based amplification with HEK293 or HeLa cells and a helper virus, followed by qPCR or assessment of cytopathic effects. uBriGene offers rcAAV testing, with a stated release criterion of fewer than 1 rcAAV per 1 × 10⁸ AAV particles.
Next-generation sequencing (NGS) can support adventitious virus detection in vaccinia virus products by enabling broad, sequence-based screening of nucleic acids in a sample. This approach is particularly useful when vaccinia virus complicates conventional cell-based detection. Method selection and validation should be appropriate for the product and testing requirements.
For GMP-grade lentiviral vectors, residual host cell DNA (HCD) fragment size is an important safety consideration. Keeping fragments below 200 base pairs (bp) helps reduce concerns about residual DNA integration and supports applicable quality requirements. uBriGene uses capillary electrophoresis (CE) to assess HCD fragment size, with a stated target of no fragments exceeding 200 bp.
Lentiviral vectors are enveloped viruses that can lose infectivity during storage. Formulation development and stability studies help determine suitable storage conditions and establish shelf life for clinical vector products and other critical materials.
Viral vector quality control and release testing may include identity, titer, potency, purity, residual impurities, and safety assays. The specific panel depends on the vector type and product requirements. uBriGene supports analytical testing for AAV, lentiviral vectors (LVV), adenovirus, and oncolytic viruses to help characterize product quality and support development and release decisions.
Lentiviral vector infectious titer can be assessed using cell-based assays that measure successful transduction. Depending on the vector and assay design, methods may include flow cytometry to quantify transgene or CAR expression, or qPCR-based methods to assess vector-related sequences. The selected method should match the product characteristics and intended testing purpose.
Yes. uBriGene supports custom viral vector analytical method development, validation, and technology transfer. Assays are selected or developed according to the vector type, product quality attributes, and development stage to support characterization, quality control, and release testing.
AAV genome titer measures vector genome copies, typically using qPCR or ddPCR. Particle titer measures the number of AAV capsids, including full and empty particles, using methods such as capsid-based assays or analytical techniques. Infectious titer measures the ability of the vector to enter target cells and deliver or express its genetic material. These measurements assess different product attributes and are not directly interchangeable.
Partner with our viral vector experts to ensure the safety, efficacy, and regulatory compliance of your therapeutic programs.
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