FDA and EMA viewpoints on virus safety in continuous bioprocessing FDA and EMA viewpoints on virus safety in continuous bioprocessing Regulatory Affairs Context In the production of biological products, ensuring virus safety is paramount. Continuous bioprocessing has emerged as a best practice, facilitating enhanced efficiency and productivity. As regulatory frameworks evolve, understanding the expectations set forth by agencies such as the FDA and EMA, as well as their specific considerations regarding viral safety, is essential for regulatory affairs professionals. With emerging technologies such as intensified upstream processing and the use of perfusion bioreactors, compliance with established guidelines is critical in…

Implementing viral safety monitoring plans for intensified upstream operations Implementing Viral Safety Monitoring Plans for Intensified Upstream Operations In the realm of biopharmaceutical manufacturing, maintaining viral safety is of paramount importance, particularly as operations intensify and embrace continuous bioprocessing methodologies. This regulatory explainer manual aims to provide a comprehensive overview of implementing viral safety monitoring plans in intensified upstream operations, emphasizing regulatory requirements and best practices from the EU, UK, and US perspectives. Regulatory Context Viral safety is a critical component of biopharmaceutical production, wherein the emergence of new viral contaminants poses significant risks to patient safety and product integrity….