Optimizing a therapeutic humanized follicle-stimulating hormone-blocking antibody formulation by protein thermal shift assay.

ABSTRACT: Biopharmaceutical products are formulated using several Food and Drug Administration (FDA) approved excipients within the inactive ingredient limit to maintain their storage stability and shelf life. Here, we have screened and optimized different sets of excipient combinations to yield a thermally stable formulation for the humanized follicle-stimulating hormone (FSH)-blocking antibody, MS-Hu6. We used a protein thermal shift assay in which rising temperatures resulted in the maximal unfolding of the protein at the melting temperature (T_m ). To determine the buffer and pH for a stable solution, four different buffers with a pH range from 3 to 8 were screened. This resulted in maximal T_m s at pH 5.62 for Fab in phosphate buffer and at pH 6.85 for Fc in histidine buffer

SUBMITTER: Sant D 

PROVIDER: S-EPMC11658029 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature