Optimizing Process Development for Biologics
Daniel Giroux, VP of Biologics Development at Abzena, discusses approaches for optimizing process development for the production of proteins.
The development and production of biologics can be a complex process. And the manufacture of biopharmaceuticals requires that processes be developed and validated so that product specifications can be met to create a safe and effective biologic drug. Sponsor companies often look to contract development and manufacturing organizations to help with process development of these products. To learn more about process development for biologics, specifically for protein production, BioPharm International® spoke with Daniel Giroux, VP of Biologics Development at Abzena to gain his perspective on cell culture, upstream processing, cell harvesting, and validation requirements.
To optimize a cell culture process, the parameters that need to be optimized must be defined, says Giroux, for titer, product quality, or both. In addition, assays should be in place to identify target product quality parameters. “Typically, for product quality, we're looking at glycosylation patterns on proteins to make sure that they are correct, or in the case of a biosimilar, that they match the originator,” Giroux says. One must then vary input parameters, both individually and in combination, and then measure their effect on productivity and product quality.
Click the video above to watch the entire interview.
