Development and Qualification of an Antigen Integrity Assay for a Plasmodium falciparum Malaria Transmission Blocking Vaccine Candidate, Pfs230.

ABSTRACT: During development of a subunit vaccine, monitoring integrity of the recombinant protein for process development and quality control is critical. Pfs230 is a leading malaria transmission blocking vaccine candidate and the first to reach a Phase 2 clinical trial. The Pfs230 protein is expressed on the surface of gametes, and plays an important role in male fertility. While the potency of Pfs230 protein can be determined by a standard membrane-feeding assay (SMFA) using antibodies from immunized subjects, the precision of a general in vivo potency study is known to be poor and is also time-consuming. Therefore, using a well-characterized Pfs230 recombinant protein and two human anti-Pfs230 monoclonal antibodies (mAbs), which have functional activity judged by SMFA, a sandwich ELISA-based in

SUBMITTER: Miura K 

PROVIDER: S-EPMC9607959 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature