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Specific Analytical Assays Capabilities

PROVEN INTELLIGENCE ACCELERATING NEXT-GENERATION THERAPIES.

Specific Analytical Assays Capabilities

Definitive Testing Intelligence Engineered for Advanced Biologicals.

CELL & GENE | RNA | BIOLOGICS

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Characterization & Analytics for Viral Vectors

A robust analytical characterization program is the foundation for successful IND submissions of advanced therapeutics and complex biologics. Applying proven intelligence in analytical strategy de-risks the path to the clinic by generating a comprehensive data package that defines product quality, purity, and potency. We employ a tailored, science-driven approach specific to the vector and target indication, moving beyond standardized templates.

Our analytics platform supports a wide range of viral vectors, including numerous AAV serotypes (AAV8, AAV9, engineered capsids), Lentivirus (LV), and Adenovirus (AdV) platforms. We provide phase-appropriate assay development, qualification, and validation under research or GxP conditions to meet program-specific regulatory requirements.

Advanced Capsid Characterization & Mass Spectrometry

Understanding the structural integrity of a viral vector is a key component of building a comprehensive safety profile. Post-translational modifications, such as the deamidation of amino acids on the surface of AAV capsids, can lead to charge heterogeneity, alter vector function, and introduce significant lot-to-lot molecular variability (PMID: 30343890). We utilize advanced mass spectrometry and high-resolution analytical techniques to identify these critical quality attributes early in development. This level of deep characterization directly informs the manufacturing process, ensuring dosing consistency and a robust safety profile for regulatory submissions.

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Core Analytical Assays for Viral Vectors

A multi-faceted analytical approach is required to fully characterize viral vector products. Our capabilities are designed to provide a complete picture of the product’s quality attributes (CQAs).

  • Vector Titer & Genome Integrity: Quantitative methods including ddPCR and qPCR to determine vector genome concentration.
  • Capsid Characterization: Analysis of capsid protein ratios and integrity using methods such as CE-SDS, SDS-PAGE, and Western Blot.
  • Purity & Aggregation: Assessment of empty, partial, and full capsids using Analytical Ultracentrifugation (AUC) and Mass Photometry.
  • Residuals & Contaminants: Quantification of process-related impurities like host cell DNA and protein to ensure product purity.
  • Identity & Potency: Development of custom, qualified cell-based potency assays to measure the biological activity of the vector, a key requirement for lot release and stability testing.

Our 100,000 square-foot facilities are equipped to handle these complex analytical workflows, ensuring that the data generated is reliable, reproducible, and suitable for inclusion in global regulatory filings like INDs and IMPDs.

Scientific Process Diagram

This content is for informational purposes. For guidance specific to your therapeutic program, please contact our team for a consultation.

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