Sr Scientist Merck & Co Inc West Point, Pennsylvania
The manufacturing and process development associated with novel biologics have led to new questions around quality attributes and strategy to establish adequate controls. This talk uses a nanobody based case study to demonstrate how to establish controls for an out of specification post translational quality attribute. Analytical and biologically relevant thresholds were established using novel algorithms and in vitro mass spectrometric and cell-based assays. A nanobody with high levels of deamidation was assessed for its ability to mount an immune response and be presented in the context of Class II MHC. Using varying levels of deamidated product, a threshold was established and equated to amount expected in final formulated dose.
Develop a strategy to assess risks around post translational quality attributes associated with novel biologics and modalities
Describe what additional control strategies would be needed for multidomain and cell based/viral gene therapy based modalities
Support the industry effort to further delineate the risks due to quality attributes by leveraging the use of novel assays and technologies as described in this proposal