Bob Schrock, PhD, senior director, global head of Process Development, at Lonza provides insight on how process controls change during development through commercialization, how cell harvesting can be optimized, and which validation and/or qualification studies are performed for cell culture.
In Part Two of this interview, BioPharm International® spoke with Bob Schrock, PhD, senior director, Global Head of Process Development, at Lonza about process controls throughout the lifecycle of cell therapies, optimizing cell therapies, and validation and qualification studies for cell culture.
Bob Schrock, PhD, senior director, global head of Process Development, at Lonza provides insight on how cell culture processes may be optimized and what kind of process studies are performed for cell culture.
Click here to watch part one of this interview.
“In earlier program stages, we tend to measure a lot more parameters more often, things [such as] metabolites, cell count, viability, [and] aseptic measurements [such as] bio burden and endotoxin. But as we gain experience with the process and confidence in the process, some of these parameters can be justified to be removed or reduced to maximize yield and remove any unnecessary intrusion into the culture,” says Schrock. “Closing the process can also justify removal of multiple sampling or at intermediate steps, and justifying these sample point removals comes from extensive process characterization studies, which are done at late clinical stage and before commercial and these are all verified in validation runs that are done during the PPQ [process performance qualification] studies.”
Click the video above to watch part two of this interview.
Bob Schrock, senior director, global head of Process Development, Cell and Gene Therapies, Lonza
Bob Schrock is senior director, global head of Process Development, CGT, at Lonza. With over 25 years of industry experience, he oversees Process and Analytical Development teams in Houston, Texas; Geleen, the Netherlands; and Siena, Italy. He led the Quality Control team at Vivante GMP Solutions when Lonza acquired Vivante in 2010 and then transitioned to lead of the BioAssay Services organization in 2018. Schrock earned his B.A. in Biochemistry from Colgate University and a PhD in Biochemistry from Vanderbilt University of Medicine. He held a postdoctoral fellowship at the University of California, San Francisco.
