Maintaining Bioprocess Validation

Bioprocess validation is not only a regulatory requirement, it is also a key component in ensuring the quality and efficiency of a biomanufacturing platform. This week’s Two Minute Tuesday educational video is the first in a four part series of interviews with Dr. Shawn Latham, Validation Manager at Shire Plc. In this video Shawn is interviewed on maintaining validation in biomanufacturing. He discusses how during filing for licensure you must prove that your process claims are true and then you must maintain that those claims are true over time. As time passes, equipment and processes may drift and so based on risk based assessments, validation measures must be established. High risk areas must be validated more frequently. For the full interview, please see the video below titled, “Maintaining a Validated State in Bioprocessing.”

bioprocess validation

The Keck Graduate Institute and WuXi Biologics have teamed together to provide technical training videos called Two Minute Tuesday videos for the bioprocessing industry.  They will deliver a new video topic every Tuesday that can quickly get you up-to-speed in understanding the complexities of biologics drug development and manufacturing.