Improving biophysical properties of a bispecific antibody scaffold to aid developability: quality by molecular design.

ABSTRACT: While the concept of Quality-by-Design is addressed at the upstream and downstream process development stages, we questioned whether there are advantages to addressing the issues of biologics quality early in the design of the molecule based on fundamental biophysical characterization, and thereby reduce complexities in the product development stages. Although limited number of bispecific therapeutics are in clinic, these developments have been plagued with difficulty in producing materials of sufficient quality and quantity for both preclinical and clinical studies. The engineered heterodimeric Fc is an industry-wide favorite scaffold for the design of bispecific protein therapeutics because of its structural, and potentially pharmacokinetic, similarity to the natural antibody. Developmen

SUBMITTER: Von Kreudenstein TS 

PROVIDER: S-EPMC3851217 | biostudies-literature | 2013 Sep-Oct

REPOSITORIES: biostudies-literature