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

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.

Medienart:

E-Artikel

Erscheinungsjahr:

2023

Erschienen:

2023

Enthalten in:

Zur Gesamtaufnahme - volume:15

Enthalten in:

Bioanalysis - 15(2023), 16 vom: 29. Aug., Seite 1049-1067

Sprache:

Englisch

Beteiligte Personen:

Li, April [VerfasserIn]
Swanson, Michael [VerfasserIn]
Sullivan, Nicole [VerfasserIn]
Homan, Ying [VerfasserIn]
Nahas, Debbie [VerfasserIn]
Mukhopadhyay, Shreya [VerfasserIn]
Li, Hualin Helen [VerfasserIn]
Cao, Yu [VerfasserIn]
Xu, Weifeng [VerfasserIn]
Tang, Huaping [VerfasserIn]
Vora, Kalpit A [VerfasserIn]
Chen, Zhifeng [VerfasserIn]

Links:

Volltext

Themen:

Anti-YTE antibody
Anti-idiotype antibody
Antibodies, Monoclonal
Antibodies, Neutralizing
Antidrug antibody
Immune response
Journal Article
MK-1654
Neutralizing antibody
Phage display
Pharmacokinetic

Anmerkungen:

Date Completed 07.09.2023

Date Revised 07.09.2023

published: Print-Electronic

Citation Status MEDLINE

doi:

10.4155/bio-2023-0081

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

NLM360154018