Viral Vector Testing Services

Enabling Quality, Safety, and Confidence in Viral Vector Manufacturing

AAV and LVV testing is a critical component of gene and cell therapy development, supporting product safety, potency, purity, and regulatory compliance. As viral vector platforms continue to diversify—and regulatory expectations evolve—developers face increasing analytical complexity across every stage of development.

Charles River delivers GMP‑compliant viral vector analytical testing designed to help gene and cell therapy developers define critical quality attributes (CQAs), meet global regulatory expectations, and maintain control of their analytical methods from early research through commercial release.

Comprehensive Viral Vector Testing Across Critical Quality Attributes

We provide end‑to‑end viral vector testing aligned with FDA, EMA, and global regulatory expectations.

Identity & Characterization

• Vector genome confirmation and sequencing
• Capsid integrity and structural characterization
• Transgene verification and genetic stability
• Next-generation sequencing (NGS) for deep characterization

Potency & Infectivity

• Product‑specific viral vector potency assays
• Infectivity and transduction efficiency testing
• Functional bioassays aligned to mechanism of action
• Phase‑appropriate assay development and validation

Purity

• Host cell protein and residual DNA analysis
• Empty/full capsid ratio determination
• Process‑related impurity testing

Safety

• Replication‑competent virus testing (RCL, RCA, RCV)
• Sterility, endotoxin, and mycoplasma
• Adventitious agent detection using NGS

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Expertise Across Viral Vector Platforms

Our scientists support vector‑specific analytical strategies tailored to each modality's unique challenges:

• AAV vectors – capsid heterogeneity, genome integrity, potency variability
• LVV – Lentiviral vectors (LVVs) are crucial for cell and gene therapy, requiring extensive testing to ensure safety for CAR-T cell therapy, replication competence, infectivity, and transgene expression. Find out more about their role and why testing is essential in this webinar, The Importance of Lentivirus Testing
• Adenoviral and retroviral vectors – safety, identity, and potency testing

Learn more about our comprehensive testing of Recombinant Adeno-Associated Virus (rAAVs).

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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Designed to Reduce Risk, Not Create Dependencies

Gene therapy developers increasingly face delays when analytical methods are owned and controlled by CDMOs. Limited transparency, assay inaccessibility, and transfer challenges can slow IND timelines and complicate scale‑up. Charles River takes a different approach.

Key Differentiators

• Method Transparency & Ownership: Assays developed to support sponsor control and easy transfer—not CDMO lock‑in.
• Regulatory‑Aligned from Day One: Testing strategies designed to support IND, CTA, IMPD, and BLA submissions.
• Phase‑Appropriate & Scalable: Build early methods with late‑stage and commercial requirements in mind.
• NGS‑Enabled Modern Testing: Advanced viral safety and characterization tools aligned with evolving regulatory expectations.
• Global Capacity & GMP Compliance: Consistent, scalable testing across a worldwide laboratory network.

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.

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Frequently Asked Questions (FAQs) About Viral Vector Testing Services