Viral Vector Testing Services

Realize the full therapeutic power of viral vectors without risking delays

Viral vectors are powerful tools for gene delivery. However, without rigorous testing their potential can become a liability. Whether you’re using adeno-associated virus (AAV) or lentivirus systems, you need the right characterization strategy to ensure your therapy reaches patients safely and efficiently.

Characterization and Release Testing for AAV Therapies
Industry experts discuss the pros and cons of different analytical methods used in the industry for phase-appropriate empty/partial/full capsid characterization and share case studies demonstrating the importance of analytical reference material for product-specific method development and validation.
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Ensure Safe, Effective Gene Therapies with End-to-End Viral Vector Testing

Confidently advance your gene therapy with GMP-compliant viral vector testing services tailored to your platform, timeline, and regulatory path. Whether you’re working with adeno-associated virus (AAV) or lentivirus vectors, we help you avoid regulatory delays, mitigate safety risks, and deliver quality data that supports every stage of development.

Viral Vector characterization and biosafety testing program

Identity

Identity confirmation is essential to de-risk your gene therapy early in development. We perform thorough drug substance (DS) and drug product (DP) testing using PCR, Sanger sequencing, restriction enzyme analysis, and Next Generation Sequencing (NGS). For cell banks, our identity testing includes short tandem repeat (STR) genotyping, DNA barcoding, PCR, and targeted NGS, ensuring genome integrity and accurate cell line verification.

Purity

Impurities can undermine safety and regulatory compliance. We conduct detailed AAV and lentivirus purity assessments, testing for host cell proteins (HCPs), host cell DNA/RNA, specific DNA contaminants, residual antibiotics, and detergents using PCR, Picogreen, ELISA, LC-MS, and HPLC. Our particle analysis and capsid characterization use AUC, cryo-TEM, CE-SDS, and DLS to determine empty/full ratios and ensure product consistency.

Potency & Strength

Demonstrating potency is critical for regulatory approval and therapeutic efficacy. We conduct a range of in vitro and in vivo potency assays for both AAV and lentivirus vectors to evaluate functional activity. Our comprehensive testing includes infectivity assays and genomic titer assays to assess the strength of the vector preparation and confirm that your therapy can trigger the intended biological response.

Safety

Regulators demand rigorous safety data; cutting corners can delay approval or endanger patients. Our biosafety testing covers every stage of development, from cell bank to final product. We perform bioburden testing, replication-competent AAV (RCAAV) and replication-competent lentivirus (RCL) testing, and screenings for endotoxin, mycoplasma, and adventitious viral contaminants. We also validate virus inactivation and removal processes to ensure manufacturing safeguards are in place.

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Scale Your Gene Therapy with Comprehensive Viral Vector Testing Services

As a contract development and manufacturing organization (CDMO) we provide viral vector testing services that scale with your program from discovery through commercialization. Our expanded AAV and lentivirus testing capabilities support faster decision-making, regulatory compliance, and efficient tech transfer.

Viral vector characterization and release testing are critical for ensuring gene therapy product safety, potency, and consistency. Our comprehensive testing services, AAV and lentivirus, support regulatory compliance and accelerate time to market. We offer a full suite of analytical methods to assess vector identity, purity, potency, and stability, leveraging advanced technologies such as qPCR, ddPCR, ELISA, and Next Generation Sequencing (NGS).

Whether you're preparing for IND or commercial launch, we generate the high-quality viral vector testing data required for successful submissions. Our expertise supports scale-up with confidence, which minimizes risk and helps you stay on schedule.

Adeno-associated Virus (AAV)

• A leading vehicle for in vivo gene therapies
• Naturally occurring serotypes and engineering variants allow for targeted delivery to various tissue types

Lentivirus

• For in vivo cell therapy development of CAR and TCR constructs
• Reliable and stable gene delivery in dividing and non-dividing cells
• Broad tropism for diverse target tissues or cell types

Recombinant Adeno-Associated Virus
Recombinant adeno-associated viruses (rAAVs) are transforming gene therapy by safely delivering therapeutic genes without integrating into the host genome. Comprehensive testing, including bioburden and replication-competent assays, ensures the safety and efficacy of the product.
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Testing Panel

Speed your regulatory path with access to a comprehensive panel of prequalified assays already included in global gene therapy submissions. Our platform methods streamline validation, reduce variability, and give you a faster, more confident route to regulatory approval. Explore our Viral Vector Test Panel Generator, a tool that provides personalized recommendations tailored to your specific testing needs, ensuring a smoother pathway to regulatory approval.

Example Testing Table for Viral Vector Testing Services

*Charles River creates fully customized assay packages to fit the requirements of each testing project.

Viral Vector Testing Panel Generator
Speed your regulatory path with a tailored recommendation for a comprehensive testing panel that suits your unique project requirements. Our platform methods streamline validation, reduce variability, and give you a faster, more confident route to regulatory approval.
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Real-time, secure access to your data

Our innovative Apollo^TM platform gives you secure, cloud-based real-time access to your sample data, milestones, and documents. With it, you can submit sample submission forms, track samples, and exchange documents all in one place — ensuring accuracy and saving time.

Confidently Advance Gene Therapies with End-to-End Viral Vector Testing Support

Our viral vector testing platform offers stability in times of change and is well-versed in testing services for all types of advanced therapies.

The Importance of Lentivirus Testing
Lentiviral vectors (LVs) are crucial for cell and gene therapy, requiring extensive testing to ensure safety. This webinar covers LV quality attributes, assessment methods, GMP-aligned strategies, and regulatory compliance with FDA and EMA guidelines.
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Frequently Asked Questions (FAQs) About Viral Vector Testing Services