Viral vectors
Viral vectors, particularly recombinant AAVs (rAAVs), are widely used in today’s gene therapy landscape. Their ability to deliver genetic material precisely and safely makes them indispensable in the development of advanced therapies. rAAVs are at the core of many groundbreaking treatments targeting rare genetic disorders with applications in ophthalmology, neurology and other therapeutic areas.
Biologically potent, analytically complex
The complexity of viral vectors demands a high level of precision and expertise, as these products are highly sensitive to variability and subject to stringent regulatory requirements. At Quality Assistance, we recognise that your viral vector program requires more than standard analytics and that’s why we bring over 20 years of analytical expertise to guide the development of your viral vector-based medicines.
From early-stage development to commercialisation, our dedicated analytical services, powered by advanced technologies and a GxP-compliant environment, help you navigate the unique challenges of viral vector development. By leveraging our deep scientific expertise and a comprehensive analytical solution, you gain reliable insights to streamline development, make informed decisions and bring your gene therapy to patients safely and efficiently.
Related products
Analytical challenges we help you solve
Developing therapies based on rAAVs involves significant challenges at every stage of the product lifecycle. These complex particles, composed of several structural proteins and a single-stranded DNA genome, are heterogeneous and prone to aggregation and degradation.
Navigating these complexities requires a deep understanding of critical quality attributes such as genome identity, capsid composition, full/empty capsid ratio and potency. Regulatory authorities demand robust data on these attributes, as well as on surfactants introduced during formulation and key impurities including host-cell proteins, host-cell DNA and enzymes.
At Quality Assistance, our integrated analytical solution provides clear answers on the identity, purity, potency, safety, and stability of your rAAV vectors, helping you to move forward with confidence.
| Residual solvents | HS-GC (FID, MS) |
|---|---|
| Elemental impurities | ICP (OES, MS) |
| Residual salts | HPAEC (conductimetry) / ICP (OES, MS) |
| Residual HCP | Immunoassays (ELISA, Gyrolab, Octet (BLI), Biacore (SPR)) / UPLC (MS/MS) for targeted proteins / 2D-DIGE for HCPs coverage of ELISA tools |
| Residual DNA | qPCR / ddPCR / Fluorescence spectroscopy |
| Residual RNA | Fluorescence spectroscopy |
| Residual benzonase | Immunoassays (ELISA, Gyrolab, BLI (Octet), SPR (Biacore)) |
| Process contaminants (CsCl, iodixanol, antifoam, Triton X100, Tween, PEI, etc.) | GC (FID, MS) / ICP (OES, MS) / (U)HPLC (UV, CAD, MS, ELSD) |
| Container Closure System Integrity | Bubbling / Dye ingress / Microbial ingress |
|---|---|
| Leachables | (HS)-GC (FID, MS, ECD) / ICP (OES, MS) / (U)HPLC (UV, ELSD, CAD, MS) |
| Cytotoxicity / Biological reactivity | Cell-based assays / USP <87> |
| Break Loose and Glide Force (BLGF) for prefilled syringes |
| Cell-based assay | Different readouts |
|---|
| Genome sequencing | NGS |
|---|---|
| Genome identity | PCR |
| Viral vector | (U)HPLC (MS) / Immunoassays (ELISA, Gyrolab, BLI (Octet), SPR (Biacore)) / SDS-PAGE |
| Viral vector aggregates | SEC-(U)HPLC (UV, RI, MALS) / AF4 (UV, RI, MALS) / DLS / Imaging Particle Analysis |
|---|---|
| Replication competent AAV | Infectivity assay (qPCR) |
| Full / Empty capsids | cGE / AEX (UV) / SEC-(U)HPLC (UV, RI, MALS) / SoloVPE |
| Genome integrity | cGE / (U)HPLC (UV) / ddPCR / qPCR |
| Protein degradation products / Modifications | (U)HPLC-MS |
| Infectious vector titre | qPCR / ddPCR |
|---|---|
| Vector particle concentration | qPCR / ddPCR / AEX / UV spectroscopy |
| Total protein | UV spectroscopy / (U)HPLC (UV) |
| Capsid concentration | Immunoassays (ELISA, Gyrolab, Octet (BLI), Biacore (SPR)) / MA-DLS |
| Assay / impurities | GC (FID, ECD, MS) / ICP (OES, MS) / (U)HPLC (UV, ELSD, CAD, MS) |
|---|
Platforms and technologies
To address the unique analytical challenges of rAAVs, we’ve invested in a comprehensive suite of state-of-the-art technologies, all integrated under one roof. Our laboratory includes the following instrumentation:
- SEC-MALS and AF4-MALS: for multi-attribute characterisation of critical attributes such as particle concentration, genome titre, aggregation, capsid size and integrity, and full/empty ratio all in a single run, with minimal sample consumption.
- Digital PCR (ddPCR): for absolute and reliable quantification of genome, detection of residual DNA and distinction of genomic variations.
- Immunoassays with Gyrolab xPlore™: for the determination of residual host cell proteins (HCP) or for identification and quantification of the capsid. Complemented by ELISA, AlphaLISA, SPR (Biacore) and BLI (Octet) depending on your needs.
- Next-Generation Sequencing (NGS): for comprehensive assessment of genome identity.
- Dynamic Light Scattering (DLS): for the determination of particle size distribution and aggregation.
By combining these advanced technologies with a full suite of orthogonal methods in a GxP-compliant environment, we deliver robust, regulatory-compliant data that accelerate your rAAV development.
Why innovators choose us
Bringing an rAAV therapy from research to market requires more than advanced analytics, it requires a partner who can anticipate obstacles, adapt to your programme, and provide continuity from early development through commercialisation.
At Quality Assistance, we act as a scientific extension of your team, ensuring that every result is not only regulatory-compliant but also actionable for faster, more confident decisions.
By centralising all expertise on a single site and drawing on over 10 years of experience of supporting companies developing viral vector therapies, we simplify complex development pathways and help you make the most of your gene therapy. This unique model gives you efficiency, transparency, and the assurance that your rAAV programme is supported with the same rigour at every stage.
Partnering with us for your rAAV programme
From genome to patient, get the data and confidence your rAAV needs.