Bridging viral spiking study data when process parameters or scale change Bridging Viral Spiking Study Data When Process Parameters or Scale Change In the realm of biopharmaceutical development, establishing the viral safety of products through viral clearance studies is critical. Among the numerous methodologies employed, viral spiking study design is a prominent technique used to assess the ability of a manufacturing process to remove or inactivate viruses. However, changes in process parameters or scale can pose challenges in ensuring that the data remains applicable. This article serves as a comprehensive guide for regulatory affairs (RA) professionals in the US, UK,…

Using Design of Experiments to Streamline Viral Spiking Study Design Using Design of Experiments to Streamline Viral Spiking Study Design In the realm of biopharmaceutical development, ensuring the safety and efficacy of products is paramount. Integral to this process is the validation of viral clearance, particularly through well-designed viral spiking studies. This regulatory explainer manual outlines the key aspects of viral spiking study design, the incorporation of worst-case models, and the utilization of design of experiments (DOE) principles to optimize the process. Regulatory Affairs Context Viral clearance studies are critical for assessing the capacity of manufacturing processes to remove or…