The article emphasizes the need for a common phase-appropriate approach to analytical assay validation, focusing on critical quality attributes (CQAs) in cell and gene therapy (CGT) modalities.

Regulatory agencies have established guidelines to expedite the development and approval processes for CGT therapies, which are crucial for treating patients with rare or life-threatening conditions.

However, current regulatory guidance is deemed insufficient for supporting analytical assays across all phases of CGT development, resulting in a lack of consensus in the field.

To address this, the article discusses the importance of identifying the criticality of quality attributes through risk-based assessments during product development.

Key steps in the analytical methods life cycle include defining analytical target profiles (ATP) and establishing potential product CQAs during the preclinical development phase.

Inadequate data packages can lead to delays in regulatory filings and approvals, ultimately impacting patient access to these vital therapies.

Bridging studies are essential when transitioning to new or revised methods, ensuring consistency and reliability throughout the validation process.

Recommendations for method qualification stress the necessity of phase-appropriate validation that aligns with International Council for Harmonisation (ICH) guidelines.

Regulatory guidelines from the FDA and EMA outline expectations for the validation and qualification of analytical methods in CGT development.

Looking ahead, the future of assay validation in CGT will require a balance between material usage and validation requirements, while also exploring platform assay validation strategies.

Each CGT product class presents unique profiles and requirements, necessitating tailored assay validation strategies to accommodate these differences.

Additionally, emerging technologies and innovative methods are transforming the landscape of assay validation in CGT, with a focus on data integrity and method selection.