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Analytics (Product & Substance Characterization) Capabilities

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Analytics (Product & Substance Characterization) Capabilities

Analytical Characterization for Viral Vectors and Plasmids

CELL & GENE | RNA | BIOLOGICS

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Rationale for a Comprehensive Analytical Strategy

A definitive analytical strategy is required for developing successful advanced therapeutics and complex biologics. For viral vectors and plasmid DNA, applying proven intelligence in product characterization directly informs program viability and de-risks the path to IND submission. Our approach builds a comprehensive data package that defines product identity, purity, potency, and stability through a multi-platform analytical strategy.

This level of detail is necessary for predictable outcomes. The path to clinical translation is sensitive to the complex biological landscape of the patient; the natural dissemination of AAVs in human tissues, for example, gives rise to pre-existing immunity that can profoundly influence a vector’s safety and efficacy (PMID: 15163731). A tailored, data-driven analytical program that fully characterizes the vector is a prerequisite for interpreting such complex biological results.

Phase-Appropriate Assay Development and Qualification

Our analytical platforms are designed to provide a multi-dimensional view of your vector product. We develop and qualify assays in a phase-appropriate manner, ensuring the data generated meets the regulatory expectations for your program’s specific stage.

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Multi-Platform Assays for Critical Quality Attribute (CQA) Assessment

Key characterization services include:

  • Identity and Purity: Multiplexed ddPCR can verify vector genome integrity and Mass Spectrometry verifies capsid protein composition.
  • Quantity and Titer: Genomic titer is determined using droplet digital PCR (ddPCR) or quantitative PCR (qPCR), while capsid titer is measured via enzyme-linked immunosorbent assay (ELISA).
  • Potency and Biological Activity: We design and execute custom cell-based potency assays that reflect the vector’s specific mechanism of action.
  • Product-Related Impurities: The ratio of full to empty capsids, a key quality attribute for vectors like AAV8 and AAV9, is quantified using Analytical Ultracentrifugation (AUC) and Mass Photometry.
  • Process-Related Residuals: Highly sensitive assays are employed to detect and quantify residual host cell DNA, host cell proteins, and plasmid DNA.

Vector-Specific Analytical Requirements

The analytical requirements for each vector type are distinct. Lentiviral vectors demand rigorous testing for replication competence, while high-capacity adenoviral platforms require detailed analysis of particle concentration and aggregation. By integrating these specific analytical considerations early, we build a data package that supports process development, demonstrates manufacturing consistency, and provides a solid foundation for IND-enabling toxicology studies.

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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