An Effective Translation: The Development of Hyaluronan-Based Medical Products From the Physicochemical, and Preclinical Aspects
This review shows the steps toward material selection focalized on the design and development of medical devices based on hyaluronan (HA). The selection is based on chemical and mechanical properties, biocompatibility, sterilization, safety, and scale-up costs. These facts play a vital role in the i...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2018-05-01
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| Series: | Frontiers in Bioengineering and Biotechnology |
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| Online Access: | https://www.frontiersin.org/article/10.3389/fbioe.2018.00062/full |
| _version_ | 1819083999373426688 |
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| author | Gloria Huerta-Ángeles Kristina Nešporová Gabriela Ambrožová Gabriela Ambrožová Lukas Kubala Lukas Kubala Vladimir Velebný |
| author_facet | Gloria Huerta-Ángeles Kristina Nešporová Gabriela Ambrožová Gabriela Ambrožová Lukas Kubala Lukas Kubala Vladimir Velebný |
| author_sort | Gloria Huerta-Ángeles |
| collection | DOAJ |
| description | This review shows the steps toward material selection focalized on the design and development of medical devices based on hyaluronan (HA). The selection is based on chemical and mechanical properties, biocompatibility, sterilization, safety, and scale-up costs. These facts play a vital role in the industrialization process. Approved medical devices containing-HA are illustrated to identify key parameters. The first part of this work involves the steps toward a complete characterization of chemical and mechanical aspects, reproducibility of the processes and scale up. In a second stage, we aimed to describe the preclinical in vitro and in vivo assays and selected examples of clinical trials. Furthermore, it is important to keep in mind the regulatory affairs during the research and development (R&D) using standardization (ISO standards) to achieve the main goal, which is the functionality and safety of the final device. To keep reproducible experimental data to prepare an efficient master file for the device, based on quality and recorded manufacturing data, and a rigorous R&D process may help toward clinical translation. A strong debate is still going on because the denominated basic research in HA field does not pay attention to the purity and quality of the raw materials used during the development. So that, to achieve the next generation of devices is needed to overcome the limitations of state of art in terms of efficacy, biodegradability, and non-toxicity. |
| first_indexed | 2024-12-21T20:41:29Z |
| format | Article |
| id | doaj.art-7edadf3d46a34bca9f97e4ac08e1e025 |
| institution | Directory Open Access Journal |
| issn | 2296-4185 |
| language | English |
| last_indexed | 2024-12-21T20:41:29Z |
| publishDate | 2018-05-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Bioengineering and Biotechnology |
| spelling | doaj.art-7edadf3d46a34bca9f97e4ac08e1e0252022-12-21T18:50:57ZengFrontiers Media S.A.Frontiers in Bioengineering and Biotechnology2296-41852018-05-01610.3389/fbioe.2018.00062366608An Effective Translation: The Development of Hyaluronan-Based Medical Products From the Physicochemical, and Preclinical AspectsGloria Huerta-Ángeles0Kristina Nešporová1Gabriela Ambrožová2Gabriela Ambrožová3Lukas Kubala4Lukas Kubala5Vladimir Velebný6Department of Research and Development, Contipro a.s., Dolní Dobrouč, CzechiaDepartment of Research and Development, Contipro a.s., Dolní Dobrouč, CzechiaFree Radical Pathophysiology, Institute of Biophysics of the Czech Academy of Sciences, Brno, CzechiaInternational Clinical Research Center, St. Anne's University Hospital Brno, Brno, CzechiaFree Radical Pathophysiology, Institute of Biophysics of the Czech Academy of Sciences, Brno, CzechiaInternational Clinical Research Center, St. Anne's University Hospital Brno, Brno, CzechiaDepartment of Research and Development, Contipro a.s., Dolní Dobrouč, CzechiaThis review shows the steps toward material selection focalized on the design and development of medical devices based on hyaluronan (HA). The selection is based on chemical and mechanical properties, biocompatibility, sterilization, safety, and scale-up costs. These facts play a vital role in the industrialization process. Approved medical devices containing-HA are illustrated to identify key parameters. The first part of this work involves the steps toward a complete characterization of chemical and mechanical aspects, reproducibility of the processes and scale up. In a second stage, we aimed to describe the preclinical in vitro and in vivo assays and selected examples of clinical trials. Furthermore, it is important to keep in mind the regulatory affairs during the research and development (R&D) using standardization (ISO standards) to achieve the main goal, which is the functionality and safety of the final device. To keep reproducible experimental data to prepare an efficient master file for the device, based on quality and recorded manufacturing data, and a rigorous R&D process may help toward clinical translation. A strong debate is still going on because the denominated basic research in HA field does not pay attention to the purity and quality of the raw materials used during the development. So that, to achieve the next generation of devices is needed to overcome the limitations of state of art in terms of efficacy, biodegradability, and non-toxicity.https://www.frontiersin.org/article/10.3389/fbioe.2018.00062/fullhyaluronanchemical modificationcross-linkedhydrogelpreclinical dataclinical data |
| spellingShingle | Gloria Huerta-Ángeles Kristina Nešporová Gabriela Ambrožová Gabriela Ambrožová Lukas Kubala Lukas Kubala Vladimir Velebný An Effective Translation: The Development of Hyaluronan-Based Medical Products From the Physicochemical, and Preclinical Aspects Frontiers in Bioengineering and Biotechnology hyaluronan chemical modification cross-linked hydrogel preclinical data clinical data |
| title | An Effective Translation: The Development of Hyaluronan-Based Medical Products From the Physicochemical, and Preclinical Aspects |
| title_full | An Effective Translation: The Development of Hyaluronan-Based Medical Products From the Physicochemical, and Preclinical Aspects |
| title_fullStr | An Effective Translation: The Development of Hyaluronan-Based Medical Products From the Physicochemical, and Preclinical Aspects |
| title_full_unstemmed | An Effective Translation: The Development of Hyaluronan-Based Medical Products From the Physicochemical, and Preclinical Aspects |
| title_short | An Effective Translation: The Development of Hyaluronan-Based Medical Products From the Physicochemical, and Preclinical Aspects |
| title_sort | effective translation the development of hyaluronan based medical products from the physicochemical and preclinical aspects |
| topic | hyaluronan chemical modification cross-linked hydrogel preclinical data clinical data |
| url | https://www.frontiersin.org/article/10.3389/fbioe.2018.00062/full |
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