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  1. Article ; Conference proceedings: Immunregulatorische Funktionen von Mesenchymalen Stromazellen in Frakturpatient:innen und Korrelation zum Heilungsverlauf

    Übelmesser, Katrin / Kupczyk, Eva / Häusner, Sebastian / Trivanovic, Drenka / Hölscher-Doht, Stefanie / Herrmann, Marietta

    Osteologie

    2024  

    Event/congress OSTEOLOGIE 2024, Wiesbaden, 2024-03-14
    Language German
    Publishing date 2024-03-13
    Publisher Georg Thieme Verlag
    Publishing place Stuttgart ; New York
    Document type Article ; Conference proceedings
    ZDB-ID 2113634-8
    ISSN 2567-5818 ; 1019-1291
    ISSN (online) 2567-5818
    ISSN 1019-1291
    DOI 10.1055/s-0044-1782093
    Database Thieme publisher's database

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  2. Article ; Online: Good Manufacturing Practice-compliant change of raw material in the manufacturing process of a clinically used advanced therapy medicinal product-a comparability study.

    Wixmerten, Anke / Miot, Sylvie / Bittorf, Patrick / Wolf, Francine / Feliciano, Sandra / Hackenberg, Stephan / Häusner, Sebastian / Krenger, Werner / Haug, Martin / Martin, Ivan / Pullig, Oliver / Barbero, Andrea

    Cytotherapy

    2023  Volume 25, Issue 5, Page(s) 548–558

    Abstract: The development of medicinal products often continues throughout the different phases of a clinical study and may require challenging changes in raw and starting materials at later stages. Comparability between the product properties pre- and post-change ...

    Abstract The development of medicinal products often continues throughout the different phases of a clinical study and may require challenging changes in raw and starting materials at later stages. Comparability between the product properties pre- and post-change thus needs to be ensured. Here, we describe and validate the regulatory compliant change of a raw material using the example of a nasal chondrocyte tissue-engineered cartilage (N-TEC) product, initially developed for treatment of confined knee cartilage lesions. Scaling up the size of N-TEC as required for the treatment of larger osteoarthritis defects required the substitution of autologous serum with a clinical-grade human platelet lysate (hPL) to achieve greater cell numbers necessary for the manufacturing of larger size grafts. A risk-based approach was performed to fulfill regulatory requirements and demonstrate comparability of the products manufactured with the standard process (autologous serum) already applied in clinical indications and the modified process (hPL). Critical attributes with regard to quality, purity, efficacy, safety and stability of the product as well as associated test methods and acceptance criteria were defined. Results showed that hPL added during the expansion phase of nasal chondrocytes enhances proliferation rate, population doublings and cell numbers at passage 2 without promoting the overgrowth of potentially contaminant perichondrial cells. N-TEC generated with the modified versus standard process contained similar content of DNA and cartilaginous matrix proteins with even greater expression levels of chondrogenic genes. The increased risk for tumorigenicity potentially associated with the use of hPL was assessed through karyotyping of chondrocytes at passage 4, revealing no chromosomal changes. Moreover, the shelf-life of N-TEC established for the standard process could be confirmed with the modified process. In conclusion, we demonstrated the introduction of hPL in the manufacturing process of a tissue engineered product, already used in a late-stage clinical trial. Based on this study, the national competent authorities in Switzerland and Germany accepted the modified process which is now applied for ongoing clinical tests of N-TEC. The described activities can thus be taken as a paradigm for successful and regulatory compliant demonstration of comparability in advanced therapy medicinal products manufacturing.
    MeSH term(s) Humans ; Chondrocytes ; Tissue Engineering ; Karyotyping ; Knee Joint
    Language English
    Publishing date 2023-03-07
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2039821-9
    ISSN 1477-2566 ; 1465-3249
    ISSN (online) 1477-2566
    ISSN 1465-3249
    DOI 10.1016/j.jcyt.2023.01.003
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    In stock of ZB MED Cologne/Königswinter

    Zs.A 5601: Show issues Location:
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    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
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  3. Article: From Single Batch to Mass Production-Automated Platform Design Concept for a Phase II Clinical Trial Tissue Engineered Cartilage Product.

    Haeusner, Sebastian / Herbst, Laura / Bittorf, Patrick / Schwarz, Thomas / Henze, Chris / Mauermann, Marc / Ochs, Jelena / Schmitt, Robert / Blache, Ulrich / Wixmerten, Anke / Miot, Sylvie / Martin, Ivan / Pullig, Oliver

    Frontiers in medicine

    2021  Volume 8, Page(s) 712917

    Abstract: Advanced Therapy Medicinal Products (ATMP) provide promising treatment options particularly for unmet clinical needs, such as progressive and chronic diseases where currently no satisfying treatment exists. Especially from the ATMP subclass of Tissue ... ...

    Abstract Advanced Therapy Medicinal Products (ATMP) provide promising treatment options particularly for unmet clinical needs, such as progressive and chronic diseases where currently no satisfying treatment exists. Especially from the ATMP subclass of Tissue Engineered Products (TEPs), only a few have yet been translated from an academic setting to clinic and beyond. A reason for low numbers of TEPs in current clinical trials and one main key hurdle for TEPs is the cost and labor-intensive manufacturing process. Manual production steps require experienced personnel, are challenging to standardize and to scale up. Automated manufacturing has the potential to overcome these challenges, toward an increasing cost-effectiveness. One major obstacle for automation is the control and risk prevention of cross contaminations, especially when handling parallel production lines of different patient material. These critical steps necessitate validated effective and efficient cleaning procedures in an automated system. In this perspective, possible technologies, concepts and solutions to existing ATMP manufacturing hurdles are discussed on the example of a late clinical phase II trial TEP. In compliance to Good Manufacturing Practice (GMP) guidelines, we propose a dual arm robot based isolator approach. Our novel concept enables complete process automation for adherent cell culture, and the translation of all manual process steps with standard laboratory equipment. Moreover, we discuss novel solutions for automated cleaning, without the need for human intervention. Consequently, our automation concept offers the unique chance to scale up production while becoming more cost-effective, which will ultimately increase TEP availability to a broader number of patients.
    Language English
    Publishing date 2021-08-13
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2775999-4
    ISSN 2296-858X
    ISSN 2296-858X
    DOI 10.3389/fmed.2021.712917
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: From Single Batch to Mass Production - Automated Platform Design Concept for a Phase II Clinical Trial Tissue Engineered Cartilage Product

    Haeusner, Sebastian / Herbst, Laura / Bittorf, Patrick / Schwarz, Thomas / Henze, Chris / Mauermann, Marc / Ochs, Jelena / Schmitt, Robert / Blache, Ulrich / Wixmerten, Anke / Miot, Sylvie / Martin, Ivan / Pullig, Oliver

    2021  

    Abstract: Art. 712917, 8 S. ... Advanced Therapy Medicinal Products (ATMP) provide promising treatment options particularly for unmet clinical needs, such as progressive and chronic diseases where currently no satisfying treatment exists. Especially from the ATMP ... ...

    Abstract Art. 712917, 8 S.

    Advanced Therapy Medicinal Products (ATMP) provide promising treatment options particularly for unmet clinical needs, such as progressive and chronic diseases where currently no satisfying treatment exists. Especially from the ATMP subclass of Tissue Engineered Products (TEPs), only a few have yet been translated from an academic setting to clinic and beyond. A reason for low numbers of TEPs in current clinical trials and one main key hurdle for TEPs is the cost and labor-intensive manufacturing process. Manual production steps require experienced personnel, are challenging to standardize and to scale up. Automated manufacturing has the potential to overcome these challenges, toward an increasing cost-effectiveness. One major obstacle for automation is the control and risk prevention of cross contaminations, especially when handling parallel production lines of different patient material. These critical steps necessitate validated effective and efficient cleaning procedures in an automated system. In this perspective, possible technologies, concepts and solutions to existing ATMP manufacturing hurdles are discussed on the example of a late clinical phase II trial TEP. In compliance to Good Manufacturing Practice (GMP) guidelines, we propose a dual arm robot based isolator approach. Our novel concept enables complete process automation for adherent cell culture, and the translation of all manual process steps with standard laboratory equipment. Moreover, we discuss novel solutions for automated cleaning, without the need for human intervention. Consequently, our automation concept offers the unique chance to scale up production while becoming more cost-effective, which will ultimately increase TEP availability to a broader number of patients.

    8
    Keywords ATMP ; autologous ; automation and robotics ; cartilage regeneration ; GMP ; manufacturing ; tissue engineering ; automation ; 610 ; 658 ; 666 ; 664 ; 688 ; 670 ; 620
    Subject code 629
    Language English
    Publishing country de
    Document type Article ; Online
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