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  1. Article: Pragmatic rules for comparability of biological medicinal products

    van der Plas, R. Martijn / Hoefnagel, Marcel H.N / Hillege, Hans L / Roes, Kit C.B

    Biologicals. 2020 Jan., v. 63

    2020  

    Abstract: Comparability is a key concept in the evaluation of both manufacturing changes and biosimilars. It constitutes a pragmatic and flexible approach which recognises that biologicals are inherently variable and that minor variations in quality attributes are ...

    Abstract Comparability is a key concept in the evaluation of both manufacturing changes and biosimilars. It constitutes a pragmatic and flexible approach which recognises that biologicals are inherently variable and that minor variations in quality attributes are often clinically irrelevant. In this discussion paper, we argue that comparability exercises rely on a number of pragmatic criteria. These criteria have been remarkably robust for 20 years of comparability exercises; however, the increased scrutiny of biosimilar applications provides an impetus for both codification and improvement of criteria for establishing comparability. Such a more rigorous, methodologically sound, approach towards comparability seems both feasible and beneficial.
    Keywords biomedical research ; drugs ; manufacturing ; research methods
    Language English
    Dates of publication 2020-01
    Size p. 97-100.
    Publishing place Elsevier Ltd
    Document type Article
    ZDB-ID 1017370-5
    ISSN 1095-8320 ; 1045-1056
    ISSN (online) 1095-8320
    ISSN 1045-1056
    DOI 10.1016/j.biologicals.2019.11.002
    Database NAL-Catalogue (AGRICOLA)

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 879: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
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  2. Article ; Online: Pragmatic rules for comparability of biological medicinal products.

    van der Plas, R Martijn / Hoefnagel, Marcel H N / Hillege, Hans L / Roes, Kit C B

    Biologicals : journal of the International Association of Biological Standardization

    2019  Volume 63, Page(s) 97–100

    Abstract: Comparability is a key concept in the evaluation of both manufacturing changes and biosimilars. It constitutes a pragmatic and flexible approach which recognises that biologicals are inherently variable and that minor variations in quality attributes are ...

    Abstract Comparability is a key concept in the evaluation of both manufacturing changes and biosimilars. It constitutes a pragmatic and flexible approach which recognises that biologicals are inherently variable and that minor variations in quality attributes are often clinically irrelevant. In this discussion paper, we argue that comparability exercises rely on a number of pragmatic criteria. These criteria have been remarkably robust for 20 years of comparability exercises; however, the increased scrutiny of biosimilar applications provides an impetus for both codification and improvement of criteria for establishing comparability. Such a more rigorous, methodologically sound, approach towards comparability seems both feasible and beneficial.
    MeSH term(s) Biosimilar Pharmaceuticals/standards ; Drug Industry/standards
    Chemical Substances Biosimilar Pharmaceuticals
    Language English
    Publishing date 2019-12-11
    Publishing country England
    Document type Journal Article
    ZDB-ID 1017370-5
    ISSN 1095-8320 ; 1045-1056
    ISSN (online) 1095-8320
    ISSN 1045-1056
    DOI 10.1016/j.biologicals.2019.11.002
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

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    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
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  3. Article: Binding of von Willebrand Factor to Collagen Type III: Role of Specific Amino Acids in the Collagen Binding Domain of vWF and Effects of Neighboring Domains

    van der Plas, R. Martijn / Gomes, Lucio / Marquart, J. Arnoud / Vink, Tom / Meijers, Joost C. M. / de Groot, Philip G. / Sixma, Jan J. / Huizinga, Eric G.

    Thrombosis and Haemostasis

    2000  Volume 83, Issue 12, Page(s) 1005–1011

    Abstract: Binding of von Willebrand Factor (vWF) to sites of vascular injury is the first step of hemostasis. Collagen types I and III are important binding sites for vWF. We have previously determined the threedimensional structure of the collagen binding A3 ... ...

    Abstract Binding of von Willebrand Factor (vWF) to sites of vascular injury is the first step of hemostasis. Collagen types I and III are important binding sites for vWF. We have previously determined the threedimensional structure of the collagen binding A3 domain of vWF (Huizinga et al., Structure 1997; 5: 1147). We hypothesized that the top face of this domain might be the collagen-binding site. Based on this hypothesis, we made seven vWF mutants (D934A/S936A, V1040A/ V1042A, D1046A, D1066A, D1069A, D1069R, and R1074A). Collagen binding of these mutants was investigated in ELISA and with Surface Plasmon Resonance (BIAcore). In addition, we studied collagen binding of mutants lacking the A2 or D4 domains, which flank the A3 domain. In ELISA, all point mutants and deletion mutants bound to collagen in amounts similar to wild type (WT)-vWF. In the BIAcore we found that WT-vWF has an apparent KD for collagen of 1-7 nM on a subunit base. The apparent kinetic parameters of the point mutants and deletion mutants were not significantly different from WT-vWF, except for DA2-vWF, which had a lower KD, indicating that the A2 domain somehow modulates binding of vWF to collagen type III. Based on our results, we conclude that the amino acid residues mutated by us are not critically involved in the interaction between vWF and collagen type III, which suggests that the collagen binding site is not located on the top face of the A3 domain.
    Keywords von Willebrand factor ; collagen ; mutagenesis ; A-domains ; platelet adhesion
    Language English
    Publishing date 2000-01-01
    Publisher Schattauer GmbH
    Publishing place Stuttgart ; New York
    Document type Article
    ZDB-ID 518294-3
    ISSN 2567-689X ; 0340-6245
    ISSN (online) 2567-689X
    ISSN 0340-6245
    DOI 10.1055/s-0037-1614163
    Database Thieme publisher's database

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    Zs.MO 433: Show issues

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  4. Article: Platelet Adhesion to Collagen: an Update

    Sixma, Jan J / van Zanten, G Henrita / Huizinga, Eric G / van der Plas, R Martijn / Verkley, Marilyn / Wu, Ya-Ping / Gros, Piet / de Groot, Philip G

    Thrombosis and Haemostasis

    1997  Volume 78, Issue 01, Page(s) 434–438

    Language English
    Publishing date 1997-01-01
    Publisher Schattauer GmbH
    Publishing place Stuttgart ; New York
    Document type Article
    ZDB-ID 518294-3
    ISSN 2567-689X ; 0340-6245
    ISSN (online) 2567-689X
    ISSN 0340-6245
    DOI 10.1055/s-0038-1657565
    Database Thieme publisher's database

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    In stock of ZB MED Cologne/Königswinter

    Uh III Zs.192: Show issues Location:
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    Zs.MO 433: Show issues

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