Viral Vector Characterization Service
The development of robust tools for the physical and functional characterization of viral vectors is essential to ensure the safety and maximize the efficacy of gene therapies. Our company is committed to helping customers gain a comprehensive understanding of the physical properties of viral vectors, including identity, purity, strength/potency, integrity, safety, and stability, throughout the gene therapy development process, from early development to full-scale manufacturing.
Background
A variety of cell and gene therapies for rare diseases are currently in clinical trials worldwide. Rapid advances in this field have led to increased regulatory scrutiny and product characterization requirements as well as bottlenecks in the supply of viral vectors. Manufacturing processes and analytical tools for viral vectors for gene therapy applications need to evolve to meet these demands. Continuous improvement and the establishment of rapid and robust viral vector characterization techniques are essential for rigorous quality control to increase the likelihood of successful development of the gene therapies that require them.
Fig. 1 Transmission electron microscopy micrographs of AAVrh.10hCLN2. (Dobnik D, et al., 2019)
Our Services
The high complexity of viral vectors is one of the challenges of their characterization and quality control testing. We are committed to establishing accurate, rapid, and reproducible analytical methods to provide our customers with closer to "real-time" data. These data can provide vital information for viral-based gene therapy development decisions to enable the manufacture of high-quality, safe, consistent, and effective products. Our characterization services cover a wide range of viral vectors, including lentiviral (LV) vectors, adenovirus vectors, and adeno-associated virus (AVV) vectors.
Quantification of Viral Vectors
We offer customers a wide range of services for the characterization of viral vectors, including confirming the identity of viral vectors and quantifying viral particles during growth, purification, final quality control, and release.
Evaluation of Viral Vector Purity
We help customers detect and quantify impurities derived from the host cell system where the vector product is produced or from downstream purification processes using sensitive and ready-to-use methods.
Capsid Analysis of Viral Vectors
We provide customers with capsid analysis of viral vectors, including purity analysis, full/empty capsid ratio determination, genome integrity analysis, and characterization of capsid proteins.
Biosafety Testing of Viral Vectors
We provide customers with biosafety assays for bacteria, fungi, mycoplasma, and exogenous viruses on drug materials to ensure the identity, efficacy, purity, and safety of gene therapies developed for rare diseases.
Stability Testing of Viral Vectors
We provide customers with a variety of technologies to test for multiple physical parameters such as pH/osmotic pressure or the presence of protein aggregates to ensure that quality properties are maintained.
Evaluation of Targeting Capabilities of Viral Vectors
We provide customers with the assessment of the targeting capabilities and biodistribution analysis of viral vectors through model systems and imaging technologies.
Why Choose Us?
- Viral vector characterization expertise
- World-class viral vector development and manufacturing facility
- The speed you need to get optimized gene therapies to the market faster
With our company, you have access to a range of platform technologies and custom assays to enable comprehensive characterization and potency assessment of viral vectors at multiple stages of gene therapy development. Whether sensitivity, accuracy, or speed is your priority, you can be confident in your decision when you choose our proven products. If you need our services, please feel free to contact us for more details.
Reference
- Dobnik, D.; et al. Accurate quantification and characterization of adeno-associated viral vectors. Frontiers in microbiology, 2019, 10: 1570.
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