BioPharm International: Optimizing Process Development for Biologics

BioPharm International’s latest issue features an interview with Abzena’s Vice President of Biologics Development, Dr Daniel Giroux, discussing insights into optimizing process development strategies for biologics.

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 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 Here to Watch the interview: Optimizing Process Development for Biologics