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Example SubstanceDefinition/trastuzumab (XML)

Responsible Owner: Biomedical Research and Regulation Work GroupStandards Status: InformativeCompartments: No defined compartments

Raw XML (canonical form + also see XML Format Specification)

Protein substance: Trastuzumab — humanised IgG1 monoclonal antibody targeting HER2 (id = "trastuzumab")

<?xml version="1.0" encoding="UTF-8"?>

<!--  Example: Trastuzumab (humanised monoclonal antibody against HER2).
     Demonstrates the new SubstanceDefinition protein backbones added for
     FHIR-57660: .protein.subunit (heavy + light chains), disulfide linkages,
     N/C-terminal modifications, .protein.gene with humanised mouse origin,
     and .relationship typed as TherapeuticTarget (HER2).  --><SubstanceDefinition xmlns="http://hl7.org/fhir">
  <id value="trastuzumab"/> 
  <identifier> 
    <system value="http://example.europa.eu/fhir/SMSId"/> 
    <value value="TRAS9123H"/> 
  </identifier> 
  <status> 
    <coding> 
      <system value="http://hl7.org/fhir/publication-status"/> 
      <code value="active"/> 
      <display value="Active"/> 
    </coding> 
  </status> 
  <classification> 
    <coding> 
      <system value="http://example.europa.eu/fhir/SubstanceType"/> 
      <code value="protein"/> 
      <display value="Protein"/> 
    </coding> 
  </classification> 
  <domain> 
    <coding> 
      <system value="http://example.europa.eu/fhir/Domain"/> 
      <code value="human"/> 
      <display value="Human use"/> 
    </coding> 
  </domain> 
  <description value="Trastuzumab — humanised IgG1 monoclonal antibody targeting the human epidermal
   growth factor receptor 2 (HER2/ErbB2). Variable regions derived from murine antibody
   4D5, grafted onto human IgG1 framework. Produced in Chinese hamster ovary (CHO)
   cells."/> 
  <code> 
    <code> 
      <coding> 
        <system value="http://example.europa.eu/fhir/Substance"/> 
        <code value="TRAS9123H"/> 
      </coding> 
    </code> 
  </code> 
  <name> 
    <name value="Trastuzumab"/> 
    <preferred value="true"/> 
    <language> 
      <coding> 
        <system value="urn:ietf:bcp:47"/> 
        <code value="en"/> 
        <display value="English"/> 
      </coding> 
    </language> 
    <official> 
      <authority> 
        <coding> 
          <system value="http://hl7.org/fhir/substance-name-authority"/> 
          <code value="INN"/> 
          <display value="INN"/> 
        </coding> 
      </authority> 
      <status> 
        <coding> 
          <system value="http://hl7.org/fhir/publication-status"/> 
          <code value="active"/> 
          <display value="Active"/> 
        </coding> 
      </status> 
    </official> 
  </name> 
  <name> 
    <name value="Herceptin"/> 
    <preferred value="false"/> 
  </name> 
  <protein> 
    <sequenceType> 
      <coding> 
        <system value="http://hl7.org/fhir/substance-sequence-type"/> 
        <code value="complete"/> 
        <display value="Complete"/> 
      </coding> 
    </sequenceType> 
    <numberOfSubunits value="2"/> 
    <disulfideLinkage value="HC22-HC96; HC144-HC200; HC222-LC214; HC228-HC228'; HC231-HC231'; HC265-HC325; HC371-HC429"/> 
    <subunit> 
      <subunit value="1"/> 
      <sequence value="EVQLVESGGGLVQPGGSLRLSCAASGFNIKDTYIHWVRQAPGKGLEWVARIYPTNGYTRYADSVKGRFTISADTSKNTAYLQMNSLRAEDTAV
      YYCSRWGGDGFYAMDYWGQGTLVTVSS..."/> 
      <length value="450"/> 
      <nTerminalModification> 
        <concept> 
          <coding> 
            <system value="http://example.europa.eu/fhir/Modification"/> 
            <code value="pyroglutamate"/> 
            <display value="Pyroglutamic acid (pE)"/> 
          </coding> 
        </concept> 
      </nTerminalModification> 
      <cTerminalModification> 
        <concept> 
          <coding> 
            <system value="http://example.europa.eu/fhir/Modification"/> 
            <code value="lysine-clipped"/> 
            <display value="C-terminal lysine clipping"/> 
          </coding> 
        </concept> 
      </cTerminalModification> 
    </subunit> 
    <subunit> 
      <subunit value="2"/> 
      <sequence value="DIQMTQSPSSLSASVGDRVTITCRASQDVNTAVAWYQQKPGKAPKLLIYSASFLYSGVPSRFSGSRSGTDFTLTISSLQPEDFATYYCQQHYT
      TPPTFGQGTKVEIK..."/> 
      <length value="214"/> 
    </subunit> 
    <gene> 
      <sequenceOrigin> 
        <coding> 
          <system value="http://hl7.org/fhir/gene-sequence-origin"/> 
          <code value="humanised-mouse"/> 
          <display value="Humanised mouse"/> 
        </coding> 
      </sequenceOrigin> 
      <gene> 
        <concept> 
          <coding> 
            <system value="http://www.genenames.org"/> 
            <code value="IGHG1"/> 
            <display value="Immunoglobulin heavy constant gamma 1"/> 
          </coding> 
        </concept> 
      </gene> 
    </gene> 
  </protein> 
  <relationship> 
    <substanceDefinitionReference> 
      <reference value="SubstanceDefinition/her2"/> 
      <display value="Receptor tyrosine-protein kinase erbB-2 (HER2)"/> 
    </substanceDefinitionReference> 
    <type> 
      <coding> 
        <system value="http://hl7.org/fhir/substance-relationship-type"/> 
        <code value="TherapeuticTarget"/> 
        <display value="Therapeutic target"/> 
      </coding> 
    </type> 
    <interaction> 
      <coding> 
        <system value="http://hl7.org/fhir/substance-interaction-type"/> 
        <code value="binding"/> 
        <display value="Binding"/> 
      </coding> 
    </interaction> 
    <measurementType> 
      <coding> 
        <system value="http://hl7.org/fhir/substance-measurement-type"/> 
        <code value="kd"/> 
        <display value="Kd"/> 
      </coding> 
    </measurementType> 
    <amountQuantity> 
      <value value="0.1"/> 
      <unit value="nM"/> 
      <system value="http://unitsofmeasure.org"/> 
      <code value="nmol/L"/> 
    </amountQuantity> 
  </relationship> 
</SubstanceDefinition> 

Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.