Presented by: Sebastijan Peljhan, PhD
Product manager and technical support
BIA Separations, Slovenia
Presented by: Dr. Patrick Sagmeister, PhD
EXPUTEC GmbH, Austria
Production of high value biological therapeutics usually involves complex manufacturing processes with high process variability. Additionally, development of robust and reliable bioprocesses can be also challenging. PAT aims to enhance bioprocess understanding and implies a holistic approach to ensure that quality is built into products by design. Efficient PAT therefore calls for fast and robust analytical techniques which enables to asses high quality information about critical quality attributes and key performance indicators as parallel as possible to the manufacturing process.
At-line monitoring of impurities and critical quality attributes in biopharmaceutical up- and downstream processes using fingerprinting HPLC