Validating NGS-Based Assays In-House for Virus Safety Assessment: A Call for Action

PDA Letter
September 5, 2024

In recent years, the biopharmaceutical industry has increasingly focused on accelerating development timelines to bring innovative therapies to patients more quickly. Validating next-generation sequencing (NGS)-based assays in-house for virus safety assessment is critical in this process. NGS is a highly sensitive method used to ensure the quality and virus safety of biotherapeutics, including monoclonal antibodies, cell-and-gene therapies, and vaccines. However, to meet the high unmet medical needs even faster, further acceleration potential must be identified. This involves transforming traditional validation processes into more rapid and efficient programs. The article highlights the evolving guidelines from regulatory bodies like the FDA and EMA, which emphasize the necessity of in-house validation of NGS-based assays to ensure accuracy, reliability, and consistency. By validating these assays internally, companies can maintain control over their processes, leading to cost reductions, faster turnaround times, and better protection of intellectual property. This approach also allows for more flexibility and adaptability to changing market needs and technologies. The trend towards internal validation signifies a new benchmark in biopharmaceuticals, potentially improving the safety and effectiveness of biotherapies.

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