AAV characterization is a critical component in the field of gene therapy, focusing on the detailed analysis of adeno-associated virus (AAV) vectors. Leveraging our extensive expertise and cutting-edge analytical capabilities, Protheragen offers a comprehensive suite of AAV characterization services to support our clients' gene therapy development efforts.
Comprehensive AAV characterization is the key to unlocking the full potential of these gene therapy vectors. By meticulously analyzing the critical quality attributes (CQAs) of AAV preparations, researchers and manufacturers can gain deep insights into the structural, functional, and purity aspects of these intricate biomolecular assemblies. This holistic understanding is essential for optimizing AAV-based therapeutics, mitigating risks, and meeting the stringent regulatory requirements imposed on these advanced medicinal products.
Fig.1 Characterization of AAV gene vectors. (Kontogiannis T., et al., 2024)
AAV vectors are considered prime candidates for gene therapy due to their low immunogenicity, ability to integrate into the host genome, and potential for long-term gene expression. Characterization of these vectors is paramount for predicting their in vivo behavior, optimizing their design, and ensuring that the therapeutic products meet regulatory standards for quality and safety.
The methods employed for AAV characterization are diverse and include both established and cutting-edge technologies. These methods are designed to probe different aspects of the vector's properties.
Table 1. Methodologies for characterization of synthetic AAV capsids. (El Andari J., et al., 2021)
| Technology | Pros | Cons |
| MS |
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| Thermostability |
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Protheragen is committed to staying at the forefront of AAV characterization technology, continuously refining our methods, and integrating new advances to provide the best possible services to our clients.
Genomic Titer Determination
We employ qPCR and dPCR to accurately measure the titer of AAV vectors, ensuring precise dosing and therapeutic efficacy.
Genome Integrity Analysis
Our NGS services provide a detailed analysis of the AAV genome, detecting any potential mutations or impurities that could affect the safety and efficacy of the vector.
Capsid Protein Characterization
Using MS, we determine the composition and modifications of the AAV capsid proteins, ensuring the vector's stability and functionality.
Genome Integrity Analysis
Our NGS services provide a detailed analysis of the AAV genome, detecting any potential mutations or impurities that could affect the safety and efficacy of the vector.
Understanding that each project has unique requirements, Protheragen offers customized AAV characterization services tailored to specific needs. Whether it's the development of new assays, optimization of existing methods, or the generation of reference materials, we work closely with our clients to ensure that their specific challenges are addressed effectively. If you are interested in our services, please feel free to contact us for more details and quotation information of related services.
References
Our AAVLinkTM platform is at the forefront of adeno-associated viral (AAV) vector development, leveraging our extensive expertise and state-of-the-art technologies to drive innovation in gene therapy.
