CONSIDERATION OF FILTER DESIGN SPACE FOR VALIDATION OF VIRUS FILTRATION IN CONTINUOUS PROCESSING APPLICATIONS

摘要

Continuous bioprocessing is rapidly gaining momentum, and seem likely to assume an increasing role in manufacturing in the coming years. This is due to the benefits of operational flexibility and efficiency, product consistency, increased quality assurance, and significant cost savings. However, as with all new technologies, there are several challenges to address. These include establishing technical strategies to implement Quality by Design principles, and subsequently, process validation into a continuous bioprocess.