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AAV Gene Therapy Characterization & Release Testing
Demonstrate the safety, identity, purity, and potency of your Adeno-Associated Virus (AAV) gene therapy with the gene therapy testing experts.
Backed by decades of GMP testing and regulatory expertise, we deliver the flexibility and support you need to propel the execution of your quality control strategy from first-in-human trials to commercialization. Explore our broad capabilities to learn why leading gene therapy companies rely on us for their testing needs.
1990
Developed the first protocols to evaluate gene therapy products for human clinical trials.
70+
AAV gene therapy programs supported across all phases of development.
75+
Years of scientific and regulatory expertise in biosafety testing of biologics.
Comprehensive AAV Testing Expertise Across the Development Journey
Analytical method development, validation, and stability
Phase appropriate method development and validation to define and measure critical quality attributes that reflect product safety and efficacy. We evolve with you during the course of the development process and help generate deeper product understanding.
Raw and ancillary materials testing
Components, reagents, or materials used during the manufacture of a gene therapy product that are not intended to be part of the final product. These materials should be tested to confirm identity, purity, safety and functionality (where appropriate).
Cell bank manufacturing and characterization
The host cell line is a critical material. Establishing a well characterized cell bank is essential to manufacturing success and product safety and quality.
Virus seed stock manufacturing and characterization
For manufacture of helper virus (if applicable)
Viral clearance
Because AAVs are amenable to viral clearance steps, ICH Q5A (R2) recommends incorporating viral clearance studies as part of development. We design custom virus panels and execute viral clearance studies specific to your production system and process.
- HEK293 cells / HSV helper
- HEK293 cells / Adenovirus helper
- Sf9 cells / BACV expression system
- HEK293 cells / Plasmid transfection
Drug substance and drug product release
Confirm critical quality attributes based on product- and process-related analytical methods.
AAV Testing Innovation Built on a Foundation of Regulatory Expertise and Engagement Fuels Confidence in your Approach to Market
Featured innovations:
- NGS applications
- Rapid methods
- Small volume testing
- Phase-appropriate method development and validation
- Regulatory expertise
Leverage Reliable, Global Capabilities to Define and Confirm Critical Quality Attributes for your Gene Therapy
Related Resources
- White Paper: Navigating Next-Generation Quality Control Strategies for AAV Testing
Explore innovative quality control strategies for AAV testing to ensure safety, efficacy, and regulatory compliance in gene therapy development.
- Viral Clearance Considerations for AAV Viral Vectors
Viral clearance strategies for AAV vectors, ensuring safety and compliance in gene therapy through effective risk mitigation techniques.
- Applying Next Generation Sequencing (NGS) to Accelerate Cell and Gene Therapy Product Development
Explore how Next Generation Sequencing accelerates cell and gene therapy development, helping to ensure safety and efficiency in product manufacturing.
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