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Placentation was reviewed and placental neonatal Fc receptor (FcRn) quantitation in the chorioallantoic placenta (CAP) and\/or inverted yolk sac placenta (InvYSP) was investigated across species throughout gestation to further understand and inform developmental toxicity testing of Fc domain\u2010containing molecules.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Quantitative mass spectrometry was used to quantify FcRn protein in CAP and\/or InvYSP throughout gestation in mouse, rat, guinea pig, rabbit, and nonhuman primate (NHP). In human placental tissues, immunohistochemistry was used to localize FcRn distribution during each trimester.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>FcRn protein was detected and concentration increased throughout gestation in mouse, rat, guinea pig, and rabbit; with InvYSP concentration markedly higher compared with CAP at all gestational ages. In contrast, NHP FcRn protein concentration in the CAP remained constant throughout gestation. In humans, during 1st trimester, FcRn occurred in decidua, maternal endothelium, and maternal and fetal macrophages. During 2nd trimester, fetal FcRn increased in syncytiotrophoblasts and fetal chorionic vessels. FcRn expression decreased in maternal endothelium near term.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>FcRn protein was detected throughout gestation (including organogenesis) in placental tissue of all animal species. Regardless of FcRn location, these data support that Fc domain\u2010containing molecules can access the embryo\u2010fetus throughout gestation in all species, with the extent of transfer likely depending on FcRn concentration and size of the placenta. This information on placental FcRn ontogeny will help improve study design and translation of nonclinical developmental toxicity data to human safety assessment of Fc domain\u2010containing molecules.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/bdr2.70058","type":"journal-article","created":{"date-parts":[[2026,5,15]],"date-time":"2026-05-15T03:24:08Z","timestamp":1778815448000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Ontogeny of Placental\n                    <scp>FcRn<\/scp>\n                    Protein During Human and Animal Pregnancy to Inform Developmental Toxicity Testing"],"prefix":"10.1002","volume":"118","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2425-2603","authenticated-orcid":false,"given":"Christopher J.","family":"Bowman","sequence":"first","affiliation":[{"name":"Pfizer  Groton Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0139-9693","authenticated-orcid":false,"given":"William J.","family":"Breslin","sequence":"additional","affiliation":[{"name":"Eli Lilly  Indianapolis Indiana USA"},{"name":"Breslin Toxicology Consulting, LLC  McCordsville, Indiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3704-9866","authenticated-orcid":false,"given":"Connie","family":"Chen","sequence":"additional","affiliation":[{"name":"Health and Environmental Sciences Institute  Washington Washington, DC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5762-7371","authenticated-orcid":false,"given":"Warren","family":"Foster","sequence":"additional","affiliation":[{"name":"McMaster University  Hamilton Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julia","family":"Hui","sequence":"additional","affiliation":[{"name":"Celgene  Summit New Jersey USA"},{"name":"Chara Consulting LLC  McCordsville, Indiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-9322-9865","authenticated-orcid":false,"given":"Beata","family":"Kusmider","sequence":"additional","affiliation":[{"name":"MMV Medicines for Malaria Venture  Geneva Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8439-7700","authenticated-orcid":false,"given":"Susan","family":"Laffan","sequence":"additional","affiliation":[{"name":"GSK  Philadelphia Pennsylvania USA"},{"name":"Amgen  Thousand Oaks California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matt","family":"Myers","sequence":"additional","affiliation":[{"name":"Celgene  Summit New Jersey USA"},{"name":"Gilead Sciences  Foster City California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lakshmi","family":"Sivaraman","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb Company  New Brunswick New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Belen","family":"Tornesi","sequence":"additional","affiliation":[{"name":"MMV Medicines for Malaria Venture  Geneva Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan","family":"Westmoreland","sequence":"additional","affiliation":[{"name":"AbbVie  Worcester Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3134-4207","authenticated-orcid":false,"given":"John M.","family":"DeSesso","sequence":"additional","affiliation":[{"name":"Exponent  Alexandria Virginia USA"},{"name":"Georgetown University School of Medicine  Washington, DC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,5,14]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.placenta.2019.02.006"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/s0198\u20108859(00)00244\u20105"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0164775"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00281\u2010009\u20100160\u20109"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/path.1700770206"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1038\/nri2747"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/978-1-4615-8936-5_5"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/keq185"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.2004325117"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/bdrb.21089"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.reprotox.2012.04.004"},{"key":"e_1_2_10_13_1","volume-title":"The Transmission of Passive Immunity From Mother to Young","author":"Brambell F. 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