Suitability of In Vitro Glycoengineering for BioPharma Production | So Good News
Sebastian Malik Marco Thomann, Pharma Technical Development Penzberg; Roche Diagnostics GmbH; Penzberg, Germany
The importance of Fc glycosylation of mAbs with respect to biological activity has been widely discussed and investigated in several studies. Different glycan species are known to contribute differently to the biological activity of therapeutic proteins. However, Although certain glycan variants are known to have a positive effect on biological activity; It may not be easy to continuously produce such a glycosylation pattern. Cell line engineering or biological process optimization can increase glycosylation uniformity or at least partially achieve certain glycan conformations. However, These procedures are time-consuming and may compromise other key parameters such as antibody yield. In addition, It is not economical to produce mAbs with certain glycan motifs in analytical quantities using such intensive approaches. This problem can be solved using this. In the closet glycoengineering (IVGE).
And in this assessment In the closet glycoengineering technology for the development of therapeutic proteins; We determine whether it is suitable for production and analysis. Enzyme activity was evaluated; implementation in the production process; This was done by considering the versatility of enzymes and the scale and quality during drug development.