{"id":181341,"date":"2021-08-04T06:34:47","date_gmt":"2021-08-04T06:34:47","guid":{"rendered":"http:\/\/facfox.com\/news\/?p=181341"},"modified":"2021-06-25T06:50:10","modified_gmt":"2021-06-25T06:50:10","slug":"bellaseno-establishes-gmp-compliant-am-facility-for-resorbable-implants","status":"publish","type":"post","link":"https:\/\/facfox.com\/news\/bellaseno-establishes-gmp-compliant-am-facility-for-resorbable-implants\/","title":{"rendered":"BellaSeno Establishes GMP-Compliant AM Facility for Resorbable Implants"},"content":{"rendered":"<p>BellaSeno GmbH, an ISO 13485-certified MedTech company developing absorbable scaffolds using additive manufacturing technologies, established a novel, leading-edge additive manufacturing facility for <a href=\"https:\/\/facfox.com\/news\/topics\/medical\" target=\"_blank\" rel=\"noopener\">medical<\/a> implants supported by the Fraunhofer Institute for Cell Therapy and Immunology IZI, Leipzig, Germany.<\/p>\n<p><img decoding=\"async\" class=\"aligncenter\" src=\"https:\/\/img.facfox.com\/imgs\/2021\/06\/177a93406ae8bed9.png\" \/><\/p>\n<p>It is one of the first GMP-compliant manufacturing facilities worldwide to include innovative features such as high-throughput additive manufacturing based on the so-called no-touch approach to significantly improve the safety and sterility of <a href=\"https:\/\/facfox.com\/news\/topics\/medical\" target=\"_blank\" rel=\"noopener\">medical<\/a> implants. Moreover, the facility allows for a seamless transition from R&amp;D to commercial-scale manufacturing and provides capabilities for both internal and contract manufacturing.<\/p>\n<p>While BellaSeno contributed its additive manufacturing expertise, Fraunhofer IZI was responsible for developing GMP-compliant processes, quality assurance and quality control. The resulting infrastructure, incl. SOPs and documentation was then certified and transferred to BellaSeno.<\/p>\n<div style=\"background-color: #eaeaea7a; padding: 15px 30px; overflow-wrap: break-word; display: flex; align-items: center; border-radius: 4px; box-shadow: -1px 4px 20px 0px #dedede; margin-top: 1em; margin-bottom: 1em;\">\n<div style=\"flex: 1; padding-right: 30px;\">\n<h4 style=\"margin-bottom: 14px;\">Manufacturing on Demand<\/h4>\n<div style=\"display: block;\">3D Printing with over 100 materials, shipping globally with competitive low cost, get quotes for your projects now!<\/div>\n<\/div>\n<p><a style=\"background-color: #0baee8; color: white; padding: 10px 20px; border-radius: 4px;\" href=\"https:\/\/facfox.com\" target=\"_self\" rel=\"noopener noreferrer\"><i class=\"fa-fw auxicon auxicon-cloud-upload\" aria-hidden=\"true\"><\/i> Get Quote<\/a><\/p>\n<\/div>\n<p>\u201cWe are delighted to have established a truly unique additive manufacturing facility together with Fraunhofer IZI,\u201d said Mohit Chhaya, PhD, Chief Executive Officer of BellaSeno. \u201cThis will not only ensure leading-edge manufacturing of our own products, but also enables us to provide contract manufacturing of resorbable <a href=\"https:\/\/facfox.com\/news\/topics\/medical\" target=\"_blank\" rel=\"noopener\">medical<\/a> implants for a wide range of <a href=\"https:\/\/facfox.com\/news\/topics\/insights\/applications\" target=\"_blank\" rel=\"noopener\">application<\/a>s.\u201d<\/p>\n<p><img decoding=\"async\" class=\"aligncenter\" src=\"https:\/\/img.facfox.com\/imgs\/2021\/06\/622b18624f054588.png\" \/><\/p>\n<p>He added that BellaSeno is one of the first European companies with an ISO13485 certification covering the entire additive design and manufacturing process. Moreover, the Company is able to reproducibly and routinely manufacture scaffolds with feature sizes down to 150-\u00b5m \u2013 an important differentiation factor in the additive manufacturing sector.<\/p>\n<p>\u201cWe are very glad to have developed a strong foundation of GMP-level production processes over the last three years in close collaboration with the Fraunhofer IZI team,\u201d  said Arpita Desai, M.E., Head of Quality Management at BellaSeno. \u201cThe exchange of knowledge throughout the project will allow us to produce implants in our new ISO 14644 Class 7 cleanroom facility at a much higher quality compared to current standards \u2013 leading to safer patient outcomes.\u201d<\/p>\n<p>&nbsp;<\/p>\n<p style=\"font-size: 14px; color: grey;\">* This article is reprinted from <a href=\"https:\/\/www.3dprintingmedia.network\/bellaseno-establishes-gmp-compliant-am-facility-for-resorbable-implants\/\" target=\"_blank\" rel=\"noopener\">3D Printing Media Network<\/a>. If you are involved in infringement, please contact us to delete it.<\/p>\n<p><i class=\"far fa-fw fa-user\"><\/i> Author: 3D Printing Media Network<\/p>\n","protected":false},"excerpt":{"rendered":"<p>BellaSeno GmbH, an ISO 13485-certified MedTech company developing absorbable scaffolds using additive manufacturing technologies, established a novel, leading-edge additive manufacturing facility for medical implants supported by the Fraunhofer Institute for Cell Therapy and Immunology IZI, Leipzig, Germany.<\/p>\n","protected":false},"author":3,"featured_media":184883,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"fifu_image_url":"https:\/\/img.facfox.com\/imgs\/2021\/06\/177a93406ae8bed9.png","fifu_image_alt":"BellaSeno Establishes GMP-Compliant AM Facility for Resorbable Implants","footnotes":""},"categories":[195],"tags":[24,127,129,3531],"class_list":["post-181341","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical","tag-3d-printing","tag-implant","tag-medical","tag-prosthetics"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.4 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>BellaSeno Establishes GMP-Compliant AM Facility for Resorbable Implants - FacFox News<\/title>\n<meta name=\"description\" content=\"BellaSeno GmbH, an ISO 13485-certified MedTech company developing absorbable scaffolds using additive manufacturing technologies, established a novel, leading-edge additive manufacturing facility for medical implants supported by the Fraunhofer Institute for Cell Therapy and Immunology IZI, Leipzig, Germany. BellaSeno GmbH, an ISO 13485-certified MedTech company developing absorbable scaffolds using additive manufacturing technologies, established a novel, leading-edge additive manufacturing facility for medical implants supported by the Fraunhofer Institute for Cell Therapy and Immunology IZI, Leipzig, Germany.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/facfox.com\/news\/bellaseno-establishes-gmp-compliant-am-facility-for-resorbable-implants\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"BellaSeno Establishes GMP-Compliant AM Facility for Resorbable Implants\" \/>\n<meta property=\"og:description\" content=\"BellaSeno GmbH, an ISO 13485-certified MedTech company developing absorbable scaffolds using additive manufacturing technologies, established a novel, leading-edge additive manufacturing facility for medical implants supported by the Fraunhofer Institute for Cell Therapy and Immunology IZI, Leipzig, Germany. BellaSeno GmbH, an ISO 13485-certified MedTech company developing absorbable scaffolds using additive manufacturing technologies, established a novel, leading-edge additive manufacturing facility for medical implants supported by the Fraunhofer Institute for Cell Therapy and Immunology IZI, Leipzig, Germany.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/facfox.com\/news\/bellaseno-establishes-gmp-compliant-am-facility-for-resorbable-implants\/\" \/>\n<meta property=\"og:site_name\" content=\"FacFox News\" \/>\n<meta property=\"article:published_time\" content=\"2021-08-04T06:34:47+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/img.facfox.com\/imgs\/2021\/06\/177a93406ae8bed9.png\" \/>\n<meta name=\"author\" content=\"Vera\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:image\" content=\"https:\/\/img.facfox.com\/imgs\/2021\/06\/177a93406ae8bed9.png\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Vera\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/facfox.com\\\/news\\\/bellaseno-establishes-gmp-compliant-am-facility-for-resorbable-implants\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/facfox.com\\\/news\\\/bellaseno-establishes-gmp-compliant-am-facility-for-resorbable-implants\\\/\"},\"author\":{\"name\":\"Vera\",\"@id\":\"https:\\\/\\\/facfox.com\\\/news\\\/#\\\/schema\\\/person\\\/7b701aad2d8f434034fcecd2c50a570c\"},\"headline\":\"BellaSeno Establishes GMP-Compliant AM Facility for Resorbable Implants\",\"datePublished\":\"2021-08-04T06:34:47+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/facfox.com\\\/news\\\/bellaseno-establishes-gmp-compliant-am-facility-for-resorbable-implants\\\/\"},\"wordCount\":363,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/facfox.com\\\/news\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/facfox.com\\\/news\\\/bellaseno-establishes-gmp-compliant-am-facility-for-resorbable-implants\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/img.facfox.com\\\/imgs\\\/2021\\\/06\\\/177a93406ae8bed9.png\",\"keywords\":[\"3d printing\",\"implant\",\"medical\",\"Prosthetics\"],\"articleSection\":[\"Medical\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/facfox.com\\\/news\\\/bellaseno-establishes-gmp-compliant-am-facility-for-resorbable-implants\\\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/facfox.com\\\/news\\\/bellaseno-establishes-gmp-compliant-am-facility-for-resorbable-implants\\\/\",\"url\":\"https:\\\/\\\/facfox.com\\\/news\\\/bellaseno-establishes-gmp-compliant-am-facility-for-resorbable-implants\\\/\",\"name\":\"BellaSeno Establishes GMP-Compliant AM Facility for Resorbable Implants - FacFox News\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/facfox.com\\\/news\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/facfox.com\\\/news\\\/bellaseno-establishes-gmp-compliant-am-facility-for-resorbable-implants\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/facfox.com\\\/news\\\/bellaseno-establishes-gmp-compliant-am-facility-for-resorbable-implants\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/img.facfox.com\\\/imgs\\\/2021\\\/06\\\/177a93406ae8bed9.png\",\"datePublished\":\"2021-08-04T06:34:47+00:00\",\"description\":\"BellaSeno GmbH, an ISO 13485-certified MedTech company developing absorbable scaffolds using additive manufacturing technologies, established a novel, leading-edge additive manufacturing facility for medical implants supported by the Fraunhofer Institute for Cell Therapy and Immunology IZI, Leipzig, Germany. 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