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.
Optimization of process development for cell culture is dependent on the type of product being produced, according to Bob Schrock, PhD, senior director, global head of Process Development, at Lonza, in an interview with BioPharm International®. Scale and purity are two important factors to consider as well if the product is cell based or single cell.
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.
Click here to watch Part Two.
When looking at viral-vector-based gene therapy products, larger and better-quality virus yields can be the result of optimizing upstream processes. “In cell therapy, the key is to scale up to gain higher cell yields while still maintaining the cell morphology and the genetic stability of the cells, so that it's the same at small scale and large scale,” says Schrock.
Process studies for cell culture include closing manual process steps to reduce contamination risks and cost of production. Automation of processes is also important, according to Schrock, especially perfusion. “One really great example of this is the Lonza Cocoon,” Schrock points out. “This is both a closed system [and] automates a lot of the process for autologous cell therapy. So, this is a really good example of doing both automation as well as closing the process. Once you have a closed process, you move to optimizing parameters that I've already mentioned, things [such as] pH, dissolved oxygen, agitation, speeds, gasses, and even temperatures, sometimes in certain viral vector types.”
Click the video above to watch part one of the interview.
Bob Schrock, PhD, senior director, global head of Process Development, 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.
