# OnCo record idea-reg-adc-platform-designation (idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)". Whole corpus: https://onco.cc/api/v1/onco.nt
@prefix schema: <https://schema.org/> .
@prefix onco: <https://onco.cc/ns#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

<https://onco.cc/ideas/idea-reg-adc-platform-designation/>
  a schema:CreativeWork ;
  onco:kind "idea" ;
  schema:identifier "idea-reg-adc-platform-designation" ;
  schema:name "Platform designation for ADC linker-payloads so manufacturing data carry across"@en ;
  schema:description "Antibody-drug conjugates built on the same linker and payload, such as deruxtecan or vedotin, share the same conjugation process, payload synthesis, impurity profile and much of the toxicology. FDA, EMA and PMDA should designate these linker-payloads as platforms so a new ADC files only antibody-specific manufacturing and toxicology data."@en ;
  schema:url <https://onco.cc/ideas/idea-reg-adc-platform-designation/> ;
  schema:dateModified "2026-09-08"^^xsd:date ;
  schema:citation <https://www.fda.gov/regulatory-information/search-fda-guidance-documents/platform-technology-designation-program-drug-development> ;
  onco:technologies <https://onco.cc/technologies/adc/>, <https://onco.cc/technologies/site-specific-conjugation/> ;
  onco:companies <https://onco.cc/companies/daiichi-sankyo/>, <https://onco.cc/companies/synaffix/>, <https://onco.cc/companies/araris/> ;
  onco:terms <https://onco.cc/terms/linker/>, <https://onco.cc/terms/payload/> ;
  onco:bottlenecks <https://onco.cc/bottlenecks/b-manufacturing-cell-therapy/>, <https://onco.cc/bottlenecks/b-regulatory-fragmentation/> .