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  <front>
    <journal-meta>
      <journal-id journal-id-type="iso-abbrev">Pharmacophore</journal-id>
      <journal-id journal-id-type="publisher-id">pharmacophorejournal.com</journal-id>
      <journal-id journal-id-type="publisher-id">Pharmacophore</journal-id>
      <journal-title-group>
        <journal-title>Pharmacophore</journal-title>
      </journal-title-group>
      <issn pub-type="epub">2229-5402</issn>
    </journal-meta>
    <article-meta>
      <article-id pub-id-type="publisher-id">pharmacophorejournal.com-6893</article-id>
      <article-id pub-id-type="doi">10.51847/00sL81Z4Dl</article-id>
      <article-categories>
        <subj-group subj-group-type="heading">
          <subject>Original research</subject>
        </subj-group>
      </article-categories>
      <title-group>
        <article-title>Predicting Biosimilar Comparability Using Glycosylation, Charge Variants, Potency, and Stability Attributes</article-title>
      </title-group>
                    <contrib-group>
                      <contrib contrib-type="author">
              <name>
                <surname>Schmidt</surname>
                <given-names>Oliver</given-names>
              </name>
                              <xref rid="aff1" ref-type="aff">1</xref>
                                                            <xref rid="cor1" ref-type="corresp" />
                          </contrib>
                      <contrib contrib-type="author">
              <name>
                <surname>Weber</surname>
                <given-names>Lukas</given-names>
              </name>
                              <xref rid="aff1" ref-type="aff">1</xref>
                                        </contrib>
                      <contrib contrib-type="author">
              <name>
                <surname>Richter</surname>
                <given-names>Jonas</given-names>
              </name>
                              <xref rid="aff2" ref-type="aff">2</xref>
                                        </contrib>
                  </contrib-group>
                  <aff id="aff1">
            <label>1</label>Department of Computational Pharmacology and AI, Faculty of Medicine, University of Stuttgart, Stuttgart, Germany.
          </aff>
                  <aff id="aff2">
            <label>2</label>Department of Intelligent Drug Systems, Faculty of Engineering, Technical University of Darmstadt, Darmstadt, Germany.
          </aff>
                          <author-notes>
            <corresp id="cor1">
              <bold>Address for correspondence:</bold> Prof. Wael Abu Dayyih, Department of
              Pharmaceutical Chemistry, Faculty of Pharmacy, Mutah University, Al-Karak 61710, Jordan.
                              E-mail: <email xlink:href="oliver.schmidt@gmail.com">oliver.schmidt@gmail.com</email>
                          </corresp>
          </author-notes>
                    <pub-date pub-type="epub">
        <day>28</day>
        <month>04</month>
        <year>2026</year>
      </pub-date>
      <volume>17</volume>
      <issue>2</issue>
      <fpage>73</fpage>
      <lpage>82</lpage>
      <permissions>
        <copyright-statement>
          Copyright: &#x000a9; 2026 Pharmacophore
        </copyright-statement>
        <copyright-year>2026</copyright-year>
        <license>
          <ali:license_ref xmlns:ali="http://www.niso.org/schemas/ali/1.0/"
            specific-use="textmining" content-type="ccbyncsalicense">
            https://creativecommons.org/licenses/by-nc-sa/4.0/</ali:license_ref>
          <license-p>This is an open access journal, and articles are distributed under the terms of
            the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows
            others to remix, tweak, and build upon the work non-commercially, as long as appropriate
            credit is given and the new creations are licensed under the identical terms.</license-p>
        </license>
      </permissions>
      <abstract>
        <title>A<sc>BSTRACT</sc></title>
        <p>Biosimilar approval hinges on demonstrating analytical and functional similarity to the reference product across a panel of quality attributes. In current practice, comparability is often assessed by comparing individual attributes against predefined acceptance ranges. Univariate comparisons can overlook the correlation structure that links glycosylation, charge heterogeneity, potency, and stability. This creates the possibility that a batch may appear acceptable attribute by attribute while remaining atypical in the broader multivariate quality space. This manuscript proposes a predictive model for estimating the overall comparability of a biosimilar batch to its reference product. The model is designed to integrate glycosylation, charge variant, potency, and stability data while identifying the attributes most responsible for predicted dissimilarity. A gradient-boosted classification framework is conceptually trained on historical batch-level characterization data from reference and biosimilar development programs. Input features encode N-glycan profiles, charge variant distributions, relative potency, and forced-degradation stability behavior, with SHAP used to explain predictions.
Conceptually, the model would provide a single comparability score for each biosimilar batch. It would also generate an interpretable attribution profile showing which quality attributes contributed most strongly to any predicted deviation. Such a predictive tool could strengthen biosimilar development by providing a transparent, multivariate assessment of analytical similarity. It could help reduce the risk of failed comparability studies and support regulatory discussions with data-driven evidence.</p>
      </abstract>
      <kwd-group>
                <kwd>Biosimilar comparability</kwd>
                <kwd>Predictive modeling</kwd>
                <kwd>Glycosylation</kwd>
                <kwd>Charge variants</kwd>
                <kwd>Potency</kwd>
                <kwd>Stability</kwd>
              </kwd-group>
    </article-meta>
  </front>
</article>