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

<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="substance-glycosylation-type"/>
  <meta>
    <lastUpdated value="2026-07-04T18:53:58.933+00:00"/>
  </meta>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml">
      <p class="res-header-id">
        <b>Generated Narrative: CodeSystem substance-glycosylation-type</b>
      </p>
      <a name="substance-glycosylation-type"> </a>
      <a name="hcsubstance-glycosylation-type"> </a>
      <p>This case-sensitive code system 
        <code>http://hl7.org/fhir/substance-glycosylation-type</code> defines the following codes:
      </p>
      <table class="codes">
        <tr>
          <td style="white-space:nowrap">
            <b>Code</b>
          </td>
          <td>
            <b>Display</b>
          </td>
          <td>
            <b>Definition</b>
          </td>
        </tr>
        <tr>
          <td style="white-space:nowrap">human
            <a name="substance-glycosylation-type-human"> </a>
          </td>
          <td>Human</td>
          <td>Glycosylation pattern from human cell lines (e.g. HEK293, PER.C6). No non-human glycan epitopes.</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">mammalian
            <a name="substance-glycosylation-type-mammalian"> </a>
          </td>
          <td>Mammalian (non-human)</td>
          <td>Glycosylation pattern from non-human mammalian cell lines such as CHO, BHK or NS0. The most common pattern for therapeutic monoclonal antibodies.</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">old-world-monkey
            <a name="substance-glycosylation-type-old-world-monkey"> </a>
          </td>
          <td>Old World Monkey</td>
          <td>Glycosylation pattern from old world monkey cell lines such as Vero or COS. Often used for vaccine production.</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">mouse
            <a name="substance-glycosylation-type-mouse"> </a>
          </td>
          <td>Murine</td>
          <td>Glycosylation pattern from murine cell lines such as NS0 or SP2/0 hybridoma. Carries the alpha-1,3-galactose epitope which can be immunogenic in humans.</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">mammalian-afucosylated
            <a name="substance-glycosylation-type-mammalian-afucosylated"> </a>
          </td>
          <td>Mammalian, afucosylated</td>
          <td>Glycosylation pattern from engineered mammalian cell lines lacking fucosyltransferase (e.g. Potelligent), producing antibodies with enhanced ADCC activity.</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">avian
            <a name="substance-glycosylation-type-avian"> </a>
          </td>
          <td>Avian</td>
          <td>Glycosylation pattern from egg-derived or avian cell line production. Common for influenza vaccines.</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">insect
            <a name="substance-glycosylation-type-insect"> </a>
          </td>
          <td>Insect cell</td>
          <td>Glycosylation pattern from insect cell expression systems such as baculovirus/Sf9. Used for some recombinant proteins and vaccines.</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">yeast
            <a name="substance-glycosylation-type-yeast"> </a>
          </td>
          <td>Yeast</td>
          <td>Native yeast glycosylation pattern (e.g. Saccharomyces cerevisiae). Examples include insulin and hepatitis B surface antigen.</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">yeast-humanised
            <a name="substance-glycosylation-type-yeast-humanised"> </a>
          </td>
          <td>Yeast, humanised</td>
          <td>Glycosylation pattern from glyco-engineered yeast (e.g. Pichia pastoris GlycoFi systems) that produces human-like glycan structures.</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">plant
            <a name="substance-glycosylation-type-plant"> </a>
          </td>
          <td>Plant</td>
          <td>Glycosylation pattern from plant or plant cell culture production (e.g. taliglucerase alfa from carrot cells).</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">bacterial
            <a name="substance-glycosylation-type-bacterial"> </a>
          </td>
          <td>Bacterial</td>
          <td>Bacterial expression (typically E. coli). Generally unglycosylated; included for completeness when the substance has been characterised as such.</td>
        </tr>
      </table>
    </div>
  </text>
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
    <valueCode value="brr"/>
  </extension>
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
    <valueCode value="informative"/>
  </extension>
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
    <valueInteger value="1"/>
  </extension>
  <url value="http://hl7.org/fhir/substance-glycosylation-type"/>
  <version value="6.0.0-ballot4"/>
  <name value="SubstanceGlycosylationTypeExample"/>
  <title value="Substance Glycosylation Type"/>
  <status value="active"/>
  <experimental value="true"/>
  <date value="2026-06-30"/>
  <publisher value="HL7 (FHIR Project)"/>
  <contact>
    <telecom>
      <system value="url"/>
      <value value="http://hl7.org/fhir"/>
    </telecom>
    <telecom>
      <system value="email"/>
      <value value="fhir@lists.hl7.org"/>
    </telecom>
  </contact>
  <description value="A categorical pattern of glycosylation for a substance, typically derived from the production cell line or source organism. Applicable to proteins and structurally diverse substances (notably vaccines) per ISO 11238."/>
  <jurisdiction>
    <coding>
      <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
      <code value="001"/>
      <display value="World"/>
    </coding>
  </jurisdiction>
  <caseSensitive value="true"/>
  <valueSet value="http://hl7.org/fhir/ValueSet/substance-glycosylation-type"/>
  <content value="complete"/>
  <concept>
    <code value="human"/>
    <display value="Human"/>
    <definition value="Glycosylation pattern from human cell lines (e.g. HEK293, PER.C6). No non-human glycan epitopes."/>
  </concept>
  <concept>
    <code value="mammalian"/>
    <display value="Mammalian (non-human)"/>
    <definition value="Glycosylation pattern from non-human mammalian cell lines such as CHO, BHK or NS0. The most common pattern for therapeutic monoclonal antibodies."/>
  </concept>
  <concept>
    <code value="old-world-monkey"/>
    <display value="Old World Monkey"/>
    <definition value="Glycosylation pattern from old world monkey cell lines such as Vero or COS. Often used for vaccine production."/>
  </concept>
  <concept>
    <code value="mouse"/>
    <display value="Murine"/>
    <definition value="Glycosylation pattern from murine cell lines such as NS0 or SP2/0 hybridoma. Carries the alpha-1,3-galactose epitope which can be immunogenic in humans."/>
  </concept>
  <concept>
    <code value="mammalian-afucosylated"/>
    <display value="Mammalian, afucosylated"/>
    <definition value="Glycosylation pattern from engineered mammalian cell lines lacking fucosyltransferase (e.g. Potelligent), producing antibodies with enhanced ADCC activity."/>
  </concept>
  <concept>
    <code value="avian"/>
    <display value="Avian"/>
    <definition value="Glycosylation pattern from egg-derived or avian cell line production. Common for influenza vaccines."/>
  </concept>
  <concept>
    <code value="insect"/>
    <display value="Insect cell"/>
    <definition value="Glycosylation pattern from insect cell expression systems such as baculovirus/Sf9. Used for some recombinant proteins and vaccines."/>
  </concept>
  <concept>
    <code value="yeast"/>
    <display value="Yeast"/>
    <definition value="Native yeast glycosylation pattern (e.g. Saccharomyces cerevisiae). Examples include insulin and hepatitis B surface antigen."/>
  </concept>
  <concept>
    <code value="yeast-humanised"/>
    <display value="Yeast, humanised"/>
    <definition value="Glycosylation pattern from glyco-engineered yeast (e.g. Pichia pastoris GlycoFi systems) that produces human-like glycan structures."/>
  </concept>
  <concept>
    <code value="plant"/>
    <display value="Plant"/>
    <definition value="Glycosylation pattern from plant or plant cell culture production (e.g. taliglucerase alfa from carrot cells)."/>
  </concept>
  <concept>
    <code value="bacterial"/>
    <display value="Bacterial"/>
    <definition value="Bacterial expression (typically E. coli). Generally unglycosylated; included for completeness when the substance has been characterised as such."/>
  </concept>
</CodeSystem>