Accelerating ATMP Release with Platform Bioassays: Smarter Strategies for Impurity Control on AAV and LVV Products

Robust impurity control is essential in viral vector manufacturing to ensure patient safety, process consistency, and timely release of ATMPs. Across AAV and LVV production processes, recurring impurities such as residual endonuclease and host cell proteins require analytical methods capable of delivering consistent, reliable performance under routine manufacturing conditions. This work presents a platform analytical strategy developed and validated in accordance with ICH guidelines, with specific focus on how the validation approach enables broad applicability across multiple viral vector products. The platform concept was implemented by harmonizing method design, predefined acceptance criteria, and system suitability requirements, allowing a single validation exercise to support multiple matrices and manufacturing platforms. Two rapid platform methods were developed: a quantitative residual endonuclease assay and a host cell protein (HCP) assay, with rapid turnaround times. The validation program included cross matrix evaluation, robustness studies reflecting routine operational variability, and performance assessments focused on accuracy, repeatability, precision, and linearity. This ensured that each method met predefined platform acceptance criteria and remained suitable for both in process monitoring and QC release testing. Additionally, both assays were designed to operate with minimal sample consumption, an important advantage in gene therapy testing where material availability is often limited and must be conserved for critical development and release activities. By integrating validated platform methods into viral vector workflows, manufacturers can streamline method lifecycle management, enhance impurity trending, and accelerate ATMP release.