DOI: 10.4155/bio-2023-0081 ISSN: 1757-6180

Phage-derived anti-idiotype and anti-YTE antibodies in development of MK-1654 pharmacokinetic and immune response assays

April Li, Michael Swanson, Nicole Sullivan, Ying Homan, Debbie Nahas, Shreya Mukhopadhyay, Hualin Helen Li, Yu Cao, Weifeng Xu, Huaping Tang, Kalpit A Vora, Zhifeng Chen
  • Medical Laboratory Technology
  • Clinical Biochemistry
  • General Pharmacology, Toxicology and Pharmaceutics
  • General Medicine
  • Analytical Chemistry

Background: MK-1654 is a fully human monoclonal antibody with YTE mutations currently in phase III clinical trials for prophylactic use in protecting infants from human respiratory syncytial virus infection. Materials & methods: We generated anti-idiotype (anti-ID) and anti-YTE antibodies against MK-1654 by panning with MorphoSys HuCal phage libraries, and used the antibodies in the development of MK-1654 pharmacokinetic (PK) and immune response (IR) assays. Results: Detection of MK-1654 in nonhuman primate and human nasal wash samples showed combined use of anti-ID and anti-YTE antibodies can deliver desired sensitivity and accuracy in PK studies. IR studies showed anti-ID can serve as suitable positive control in neutralizing antibody assays. Conclusion: Phage-derived anti-IDs and anti-YTEs are suitable for PK and IR assays.

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