Potential aggregation prone regions in biotherapeutics: A survey of commercial monoclonal antibodies.

ABSTRACT: Aggregation of a biotherapeutic is of significant concern and judicious process and formulation development is required to minimize aggregate levels in the final product. Aggregation of a protein in solution is driven by intrinsic and extrinsic factors. In this work we have focused on aggregation as an intrinsic property of the molecule. We have studied the sequences and Fab structures of commercial and non-commercial antibody sequences for their vulnerability towards aggregation by using sequence based computational tools to identify potential aggregation-prone motifs or regions. The mAbs in our dataset contain 2 to 8 aggregation-prone motifs per heavy and light chain pair. Some of these motifs are located in variable domains, primarily in CDRs. Most aggregation-prone motifs are rich in b

SUBMITTER: Wang X 

PROVIDER: S-EPMC2726584 | biostudies-literature | 2009 May-Jun

REPOSITORIES: biostudies-literature