Can you provide a timeline of your continuous manufacturing runs?
This question is part of the following Ask The Expert session:
Implementation of Continuous Manufacturing Strategies for Protein Therapeutics
Company: WuXi Biologics
Job Title: Vice President, Cell Culture Process Development
Timelines from cell expansion through continuous cell culture and potentially continuous downstream purification can vary widely pending on a multitude of factors that include actual product demand, the scale of bioreactors, the expression levels of the product and if continuous downstream is utilized, production timelines are impacted by pooling/holding strategy, the number of cycles required in continuous downstream purification which is dependent on the column matrix and size of column (amongst other factors) and certainly cost considerations all can impact the overall manufacturing timeline. We have conducted continuous cell culture for clinical production that ranges from 30 days to 60 days (and this range is consistent with many of the well-publicized industry continuous processes that manufacture commercial products). Thus, you can see that there is no standard timeline or general guideline for continuous manufacturing timelines and therefore it is a case-by-case situation.