胶原蛋白基再生医疗产品质量控制
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摘要
由于胶原蛋白具有良好的生物相容性、可降解性、生物活性及可加工性等,作为再生医疗产品中重要的生物材料,被广泛应用于神经、骨、软骨、肌腱、韧带、血管植入物和皮肤修复中。为了保证胶原蛋白基再生医疗产品的安全和有效,有必要建立适当的质量控制体系。本文重点从原材料、产品性能、病毒去除/灭活、包装和灭菌等方面来探讨胶原蛋白基再生医疗产品质量控制的考虑要点,为该类产品的研发、生产及监管提供技术参考。
Because collagen has good biocompatibility, biodegradability, bioactivity and processability, it is widely used as an important biological material in regenerative medical products. It is also widely used in nerve,bone, cartilage, tendon, ligament and blood vessel implantation as well as skin substitute. In order to ensure the safety and efficiency of collagen-based regenerative medical products, it is necessary to establish an appropriate quality control system. This paper focuses on the consideration of quality control of collagen-based regenerative medical products from the aspects of raw materials, product performance, virus removal/inactivation, packaging and sterilization in order to provide technical references for the research and development, production and supervision of such products.
Because collagen has good biocompatibility, biodegradability, bioactivity and processability, it is widely used as an important biological material in regenerative medical products. It is also widely used in nerve,bone, cartilage, tendon, ligament and blood vessel implantation as well as skin substitute. In order to ensure the safety and efficiency of collagen-based regenerative medical products, it is necessary to establish an appropriate quality control system. This paper focuses on the consideration of quality control of collagen-based regenerative medical products from the aspects of raw materials, product performance, virus removal/inactivation, packaging and sterilization in order to provide technical references for the research and development, production and supervision of such products.
引文
[1]Dong Chanjuan,Lv Yonggang. Application of Collagen Scaffold in Tissue Engineering:Recent Advances and New Perspectives[J]. Polymer,2016,8(2),42.
[2]Pawelec K M,Best S M,Cameron R E. Collagen:a Network for Regenerative Medicine[J]. J Mater Chem B Mater Biol Med,2016,4(40):6484-6496.
[3]Peng Y Y,Glattauer V,Ramshaw J A,et al. Evaluation of the Immunogenicity and Cell Compatibility of Avian Collagen for Biomedical Applications[J]. J Biomed Mater Res Part A,2010,93(4):1235-1244.
[4]杜晓丹,方玉,奚廷斐,等.动物源性胶原的生产、应用及其免疫原性[J].中国组织工程研究与临床康复,2008,12(23):4511-4514.
[5]WolfK,Alexander S,Schacht V,et al. Collagen-based Cell Migration Models in Vitro and in Vivo[J]. Semin Cell Dev Biol,2009,20:931-941.
[6]国家药品监督管理局.医疗器械数据查询[EB/OL].[2018-12-10]. http://samr.cfda.gov.cn/WS01/CL1026/.
[7]FDA. Medical Device Databaes[EB/OL].[2018-12-10].https://www.fda.gov/MedicalDevices/default.htm.
[8]Youhwan Kim,Hyojin Ko,Ik Keun Kwon. Extracellular Matrix Revisited:Roles in Tissue Engineering[J]. Int Neurourol J,2016,20(1):23-29.
[9]Ioana LaviniaArdelean,Dragos Gudovan,Denisa Ficai,et al. Collagen/Hydroxyapatite Bone Grafts Manufactured by Homogeneous/Heterogeneous 3D Printing[J]. Materials Letters,2018,231(15):179-182.
[10]ZhangDawei,WuXiaowei,ChenJingdi.The Development of Collagen Based Composite Scaffolds for Bone Regeneration[J]. Bioactive Materials,2018,3:129-138.
[11]Lynn A K,Yannas I V,Bonfield W. Antigenicity and Immunogenicity of Collagen[J]. Journal of Biomedical Materials Research Part B Applied Biomaterials. 2004,71B(2):343-354.
[12]胡康,张伟.胶原蛋白作为医用生物材料对缺损组织修复、再生及重建的作用与意义[J].中国组织工程研究,2019,(2):1-6.
[13]史新立,谭芳奕,王召旭,等.疯牛病病原体研究及动物源性医疗器械产品安全性思考[J].中国修复重建外科杂志,2006,20(11):1138-1144.
[14]张世庆,卢红,郭准,等.关于植入性医疗器械生产质量管理规范的几点思考[J].中国医疗器械信息,2017,3:30-33.
[15]YY/T0771.1-2009动物源医疗器械第1部分:风险管理应用[S]. 2009.
[16]YY/T0771.2-2009动物源医疗器械第2部分:来源、收集与处置的控制[S]. 2009.
[17] Gu Lisha,Shan Tiantian,Ma Yu-xuan,et al. Novel Biomedical Applications of Crosslinked Collagen[J]. Trends in Biotechnology,2018,Doi:https://doi.org/10.1016/j.tibtech. 2018. 10. 007.
[18]Delgado L,Bayon Y,Pandit A,et al. To Cross-link or not to Cross-link? Cross-linking Associated Foreign Body Response of Collagen-based Devices[J]. Tissue Eng Part B Rev,2015,21(3):298-313.
[19]Wang W,Zhang Y,Ye R,et al. Physical Crosslinkings of Edible Collagen Casing[J]. Int J Biol Macromol,2015,81:920–925.
[20]TakitohT,BesshoM,HiroseM,etal.Gammacross-linked Nonfibrillar Collagen Gel as a Scaffold for Osteogenic Differentiation of Mesenchymal Stem Cells[J]. J Biosci Bioeng,2015,119:217–225.
[21]Levy R J,Schoen F J,Sherman F S,et al. Calcification ofSubcutaneouslyImplantedTypeICollagen Sponges Effects of Formaldehyde and Glutaraldehyde Pretreatments[J]. Am J Pathol,1986,122(1):71-82.
[22]Brown B N,Londono R,Tottey S,et al. Macrophage Phenotype as a Predictor of Constructive Remodeling Following the Implantation of Biologically Derived Surgical Mesh Materials[J]. Acta Biomater,2012,8(3):978-987.
[23]Ye Qingsong,Harmsen M C,van Luyn M J,et al. The Relationship Between Collagen Scaffold Cross-linking Agents and Neutrophils in the Foreign Body Reaction[J].Biomaterials,2010,31(5):9192-9201
[24]McDade J K,Brennan-Pierce E P,Ariganello M B,et al. Interactions of U937 Macrophage-like Cells with Decellularized Pericardial Matrix Materials:Influence of Crosslinking Treatment[J]. Acta Biomater,2013,9:7191-7199.
[25]董教明,莫秀梅,李雨,等.天然组织去细胞技术的研究进展[J].生物医学工程学杂志,2012,29(5):1007-1013.
[26]Keane T J,Swinehart L T,Badylak S F. Methods of Tissue Decellularization Used for Preparation of Biologic Scaffolds and in Vivo Relevance[J]. Methods,2015,84:25-34.
[27]Komsa-Penkova R,Koynova R,Kostov G,et al. Thermal Stability of Calf Skin Collagen Type I in Salt Solutions[J].BBA Protein Struct Mol Enzymol,1996,1297(2):171–181.
[28]Mullen L M,Best S M,Brooks R A,et al. Binding and Release Characteristics of Insulin-like Growth Factor-1from a Collagen Glycosaminoglycan Scaffold[J]. Tissue Engineering:Part C,2010,16(6):1439-1448.
[29]Murphy C M,Haugh M G,O'Brien F J,et al. The Effect of Mean Pore Size on Cell Attachment,Proliferation and Migration in Collagen-glycosaminoglycan Scaffolds for Bone Tissue Engineering[J]. Biomaterials,2010,31(3):461-466.
[30]Pawelec K M,Husmann A,Best S M,et al. Altering CrystalGrowthandAnnealinginIce-templated Scaffolds[J]. J Mater Sci,2015,50:7537-7543.
[31]Ashworth J C,Mehr M,Buxton P G,et al. Cell Invasion in Collagen Scaffold Architectures Characterized by Percolation Theory[J]. Adv Healthc Mater,2015,4(9):1317-1321.
[32] Takashi Hoshiba,Lu Hongxu,Naoki Kawazoe,et al.Decellularized Matrices for Tissue Engineering[J]. Expert Opin Biol Ther,2010,10(12):1717-1728.
[33]GB/T16886.1-2011医疗器械生物学评价第1部分:风险管理过程中的评价与试验[S]. 2011
[34]章娜,徐丽明,邵安良,等.浅谈动物源性医疗器械的产业发展和监管现状[J].中国药事,2013,27(8):779-786.
[35]YY/T0606.14-2014组织工程医疗产品第14部分:评价基质及支架免疫反应的试验方法–ELISA法[S].2014.
[36]YY/T0606.15-2014组织工程医疗产品第15部分:评价基质及支架免疫反应的试验方法–淋巴细胞增殖试验[S]. 2014.
[37]YY/T0606.20-2014组织工程医疗产品第20部分:评价基质及支架免疫反应的试验方法–细胞迁移试验[S].2014.
[38]YY/T1561-2017组织工程医疗器械产品动物源性支架材料残留α-gal抗原检测[S]. 2017.
[39]YY/T0771.3-2009动物源医疗器械第3部分:病毒和传播性海绵状脑病因子去除与灭活的确认[S]. 2009.
[40]国家药品监督管理局.国药监械[2017]224号动物源性医疗器械注册技术审查指导原则[S]. 2017.
[41]中国药典四部1421:灭菌法[S]. 2015.
[42]YY/T0567.2-2005医疗产品的无菌加工第2部分:过滤[S]. 2005.
[43]GB 18279.1-2015医疗保健产品灭菌环氧乙烷第1部分:医疗器械灭菌过程的开发、确认和常规控制的要求[S]. 2015.
[44]GB18280.1-2015医疗保健产品灭菌辐射第1部分:医疗器械灭菌过程的开发、确认和常规控制要求[S].2015.
[45]GB18280.2-2015医疗保健产品灭菌辐射第2部分:建立灭菌剂量[S]. 2015.
[2]Pawelec K M,Best S M,Cameron R E. Collagen:a Network for Regenerative Medicine[J]. J Mater Chem B Mater Biol Med,2016,4(40):6484-6496.
[3]Peng Y Y,Glattauer V,Ramshaw J A,et al. Evaluation of the Immunogenicity and Cell Compatibility of Avian Collagen for Biomedical Applications[J]. J Biomed Mater Res Part A,2010,93(4):1235-1244.
[4]杜晓丹,方玉,奚廷斐,等.动物源性胶原的生产、应用及其免疫原性[J].中国组织工程研究与临床康复,2008,12(23):4511-4514.
[5]WolfK,Alexander S,Schacht V,et al. Collagen-based Cell Migration Models in Vitro and in Vivo[J]. Semin Cell Dev Biol,2009,20:931-941.
[6]国家药品监督管理局.医疗器械数据查询[EB/OL].[2018-12-10]. http://samr.cfda.gov.cn/WS01/CL1026/.
[7]FDA. Medical Device Databaes[EB/OL].[2018-12-10].https://www.fda.gov/MedicalDevices/default.htm.
[8]Youhwan Kim,Hyojin Ko,Ik Keun Kwon. Extracellular Matrix Revisited:Roles in Tissue Engineering[J]. Int Neurourol J,2016,20(1):23-29.
[9]Ioana LaviniaArdelean,Dragos Gudovan,Denisa Ficai,et al. Collagen/Hydroxyapatite Bone Grafts Manufactured by Homogeneous/Heterogeneous 3D Printing[J]. Materials Letters,2018,231(15):179-182.
[10]ZhangDawei,WuXiaowei,ChenJingdi.The Development of Collagen Based Composite Scaffolds for Bone Regeneration[J]. Bioactive Materials,2018,3:129-138.
[11]Lynn A K,Yannas I V,Bonfield W. Antigenicity and Immunogenicity of Collagen[J]. Journal of Biomedical Materials Research Part B Applied Biomaterials. 2004,71B(2):343-354.
[12]胡康,张伟.胶原蛋白作为医用生物材料对缺损组织修复、再生及重建的作用与意义[J].中国组织工程研究,2019,(2):1-6.
[13]史新立,谭芳奕,王召旭,等.疯牛病病原体研究及动物源性医疗器械产品安全性思考[J].中国修复重建外科杂志,2006,20(11):1138-1144.
[14]张世庆,卢红,郭准,等.关于植入性医疗器械生产质量管理规范的几点思考[J].中国医疗器械信息,2017,3:30-33.
[15]YY/T0771.1-2009动物源医疗器械第1部分:风险管理应用[S]. 2009.
[16]YY/T0771.2-2009动物源医疗器械第2部分:来源、收集与处置的控制[S]. 2009.
[17] Gu Lisha,Shan Tiantian,Ma Yu-xuan,et al. Novel Biomedical Applications of Crosslinked Collagen[J]. Trends in Biotechnology,2018,Doi:https://doi.org/10.1016/j.tibtech. 2018. 10. 007.
[18]Delgado L,Bayon Y,Pandit A,et al. To Cross-link or not to Cross-link? Cross-linking Associated Foreign Body Response of Collagen-based Devices[J]. Tissue Eng Part B Rev,2015,21(3):298-313.
[19]Wang W,Zhang Y,Ye R,et al. Physical Crosslinkings of Edible Collagen Casing[J]. Int J Biol Macromol,2015,81:920–925.
[20]TakitohT,BesshoM,HiroseM,etal.Gammacross-linked Nonfibrillar Collagen Gel as a Scaffold for Osteogenic Differentiation of Mesenchymal Stem Cells[J]. J Biosci Bioeng,2015,119:217–225.
[21]Levy R J,Schoen F J,Sherman F S,et al. Calcification ofSubcutaneouslyImplantedTypeICollagen Sponges Effects of Formaldehyde and Glutaraldehyde Pretreatments[J]. Am J Pathol,1986,122(1):71-82.
[22]Brown B N,Londono R,Tottey S,et al. Macrophage Phenotype as a Predictor of Constructive Remodeling Following the Implantation of Biologically Derived Surgical Mesh Materials[J]. Acta Biomater,2012,8(3):978-987.
[23]Ye Qingsong,Harmsen M C,van Luyn M J,et al. The Relationship Between Collagen Scaffold Cross-linking Agents and Neutrophils in the Foreign Body Reaction[J].Biomaterials,2010,31(5):9192-9201
[24]McDade J K,Brennan-Pierce E P,Ariganello M B,et al. Interactions of U937 Macrophage-like Cells with Decellularized Pericardial Matrix Materials:Influence of Crosslinking Treatment[J]. Acta Biomater,2013,9:7191-7199.
[25]董教明,莫秀梅,李雨,等.天然组织去细胞技术的研究进展[J].生物医学工程学杂志,2012,29(5):1007-1013.
[26]Keane T J,Swinehart L T,Badylak S F. Methods of Tissue Decellularization Used for Preparation of Biologic Scaffolds and in Vivo Relevance[J]. Methods,2015,84:25-34.
[27]Komsa-Penkova R,Koynova R,Kostov G,et al. Thermal Stability of Calf Skin Collagen Type I in Salt Solutions[J].BBA Protein Struct Mol Enzymol,1996,1297(2):171–181.
[28]Mullen L M,Best S M,Brooks R A,et al. Binding and Release Characteristics of Insulin-like Growth Factor-1from a Collagen Glycosaminoglycan Scaffold[J]. Tissue Engineering:Part C,2010,16(6):1439-1448.
[29]Murphy C M,Haugh M G,O'Brien F J,et al. The Effect of Mean Pore Size on Cell Attachment,Proliferation and Migration in Collagen-glycosaminoglycan Scaffolds for Bone Tissue Engineering[J]. Biomaterials,2010,31(3):461-466.
[30]Pawelec K M,Husmann A,Best S M,et al. Altering CrystalGrowthandAnnealinginIce-templated Scaffolds[J]. J Mater Sci,2015,50:7537-7543.
[31]Ashworth J C,Mehr M,Buxton P G,et al. Cell Invasion in Collagen Scaffold Architectures Characterized by Percolation Theory[J]. Adv Healthc Mater,2015,4(9):1317-1321.
[32] Takashi Hoshiba,Lu Hongxu,Naoki Kawazoe,et al.Decellularized Matrices for Tissue Engineering[J]. Expert Opin Biol Ther,2010,10(12):1717-1728.
[33]GB/T16886.1-2011医疗器械生物学评价第1部分:风险管理过程中的评价与试验[S]. 2011
[34]章娜,徐丽明,邵安良,等.浅谈动物源性医疗器械的产业发展和监管现状[J].中国药事,2013,27(8):779-786.
[35]YY/T0606.14-2014组织工程医疗产品第14部分:评价基质及支架免疫反应的试验方法–ELISA法[S].2014.
[36]YY/T0606.15-2014组织工程医疗产品第15部分:评价基质及支架免疫反应的试验方法–淋巴细胞增殖试验[S]. 2014.
[37]YY/T0606.20-2014组织工程医疗产品第20部分:评价基质及支架免疫反应的试验方法–细胞迁移试验[S].2014.
[38]YY/T1561-2017组织工程医疗器械产品动物源性支架材料残留α-gal抗原检测[S]. 2017.
[39]YY/T0771.3-2009动物源医疗器械第3部分:病毒和传播性海绵状脑病因子去除与灭活的确认[S]. 2009.
[40]国家药品监督管理局.国药监械[2017]224号动物源性医疗器械注册技术审查指导原则[S]. 2017.
[41]中国药典四部1421:灭菌法[S]. 2015.
[42]YY/T0567.2-2005医疗产品的无菌加工第2部分:过滤[S]. 2005.
[43]GB 18279.1-2015医疗保健产品灭菌环氧乙烷第1部分:医疗器械灭菌过程的开发、确认和常规控制的要求[S]. 2015.
[44]GB18280.1-2015医疗保健产品灭菌辐射第1部分:医疗器械灭菌过程的开发、确认和常规控制要求[S].2015.
[45]GB18280.2-2015医疗保健产品灭菌辐射第2部分:建立灭菌剂量[S]. 2015.
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