Averix Bio, a Botanical-based Cannabinoid Supplier, Achieves cGMP 21 CFR Part 210 and Part 211 and ICH Q7 Compliance

Averix Bio是一家以植物为基础的大麻素供应商,符合cGMP 21 CFR第210和211部分以及ICH Q7

2021-10-14 10:00:05 BioSpace

本文共1406个字,阅读需4分钟

Pharmaceutical, nutraceutical and cosmetic companies can now secure API Phytocannabinoid CBD isolate for preclinical, clinical and manufacturing Wilson, N.C., (Oct. 13, 2021) — Averix Bio is proud to announce that it has successfully completed an independent audit for 21 CFR Part 210 and Part 211 cGMP compliance of API phytocannabinoid CBD isolate in the U.S. as well as for ICH Q7 standards. “This is an historic milestone for Averix Bio, the biopharmaceutical sector and the CBD industry,” said Miles Wright, CEO of Averix Bio. “By reaching the FDA’s rigorous criteria for producing active pharmaceutical ingredients, Averix is proud to help drive research, launch APIs and finished products, and collaborate with partners as a science-driven manufacturer that minimizes supply-chain risk. We will partner with life science and other companies exploring the use of cannabinoids in their products and research.” The compliance audit was conducted by the ProPharma Group, a leading global, independent, single-source provider of regulatory, clinical and compliance services serving pharmaceutical, biotechnology and medical device companies. The Averix quality assurance team has more than six decades of cGMP pharmaceutical experience from preclinical and clinical research through commercial production at firms such as GSK, Pfizer, Novartis, Roche and Genentech. “The depth and breadth of our team’s life science experience provide peace-of-mind for scientists and pharmaceutical manufacturers that need materials that meet FDA standards,” Mr. Wright said. Located in North Carolina’s Research Triangle region, the company operates the largest industrial hemp research, extraction and production company in the eastern U.S. with a 200,000-square-foot facility on a 36-acre campus. The site comprises research and production suites, analytical testing laboratories, and climate-controlled biomass storage facilities. Since its launch in 2018, Averix has built a global footprint for its products, exporting a range of ingredients to countries on multiple continents. In addition, Mr. Wright highlighted Averix Bio’s proprietary 2021 hemp cultivation program that the company is currently conducting. “Averix is pioneering a fully transparent and highly controlled program with select industrial hemp farmers and genetic companies to gather data on genetics, nutrients, organic practices and the benefits of heightened consistency and quality management,” he noted. “Averix will be the ingredient partner of choice for manufacturers in multiple sectors looking for a tier 1 vendor,” said Mark Ward, Vice President of Sales and Marketing. "Most companies are very interested in reducing their supply chain risks – Averix is your insurance policy.” “Averix Bio is a science-driven company dedicated to companies who need a highly compliant manufacturing partner,” said Mr. Wright. “This third-party audit validates our deep commitment to provide safer and more efficacious ingredients for pharmaceutical and nutraceutical products that can benefit patients in need.” About Averix Bio Averix Bio is a U.S.-based cannabinoid research and extraction company producing 21 CFR Part 210 and Part 211-compliant cGMP API Phytocannabinoid ingredients. The company offers a full array of the highest-quality cannabinoid ingredients for use in the pharmaceutical, nutraceutical, food and beverage, and cosmetic sectors. Averix Bio ensures consistent quality from seed to shelf, forming the cornerstone of a corporate foundation built on traceability, transparency and trust. Led by a world-class team with decades of cGMP and pharmaceutical experience, Averix Bio is on a mission to bring healthier cannabinoid-based medical solutions to patients around the world. For more information, visit www.averixbio.com.   ###   Media Contacts Kevin Rudolph Averix Bio kevin@averixbio.com +1 919.432.4548 Roger Friedensen, APR Forge Communications roger@forgecommunications.com +1 919.349.3206
制药、营养和化妆品公司现在可以确保 用于临床前、临床和生产的原料药植物大麻素CBD分离物 北卡罗来纳州威尔逊(2021年10月13日)--阿维生物公司自豪地宣布,它已经成功完成了对美国API植物大麻素CBD分离物的21 CFR第210部分和211部分cGMP符合性以及ICH Q7标准的独立审计。 Averix Bio首席执行官迈尔斯·赖特(Miles Wright)表示:“对于Averix Bio、生物制药行业和CBD行业来说,这是一个历史性的里程碑。”“通过达到美国食品和药物管理局生产活性药物成分的严格标准,Averix自豪地帮助推动研究,推出原料药和成品,并作为一个科学驱动的制造商与合作伙伴合作,将供应链风险降至最低。我们将与生命科学和其他公司合作,探索大麻素在其产品和研究中的使用。“ 合规审计由ProPharma集团进行,该集团是一家领先的全球独立单一来源监管、临床和合规服务提供商,为制药、生物技术和医疗器械公司提供服务。 Averix质量保证团队在葛兰素史克、辉瑞、诺华、罗氏和基因泰克等公司拥有60多年的cGMP制药经验,从临床前和临床研究到商业生产。“我们团队生命科学经验的深度和广度为需要符合FDA标准的材料的科学家和制药商提供了安心,”赖特先生说。 该公司位于北卡罗来纳州的研究三角地区,经营着美国东部最大的工业大麻研究、提取和生产公司,在36英亩的校园内拥有20万平方英尺的设施。该场地包括研究和生产套件、分析测试实验室和气候控制的生物量储存设施。自2018年推出以来,Averix已经为其产品建立了全球足迹,向多大洲的国家出口了一系列成分。 此外,赖特先生强调了Averix Bio目前正在进行的专有的2021年大麻种植计划。他指出:“Averix正在开创一个完全透明和高度控制的项目,与精选的工业大麻农民和基因公司合作,收集关于遗传学、营养素、有机做法以及提高一致性和质量管理的好处的数据。” “Averix将是寻找一级供应商的多个行业制造商的首选配料合作伙伴,”销售和营销副总裁马克·沃德说。“大多数公司对降低他们的供应链风险非常感兴趣--Averix是你的保险单。” “Averix Bio是一家科学驱动的公司,致力于为那些需要高度合规的制造合作伙伴的公司服务,”赖特先生说。“这次第三方审计验证了我们的坚定承诺,即为药物和营养产品提供更安全、更有效的成分,使有需要的患者受益。” 关于Averix Bio Averix Bio是一家总部位于美国的大麻素研究和提取公司,生产21种符合CFR第210部分和第211部分的cGMP API植物大麻素成分。该公司提供一系列最高质量的大麻素成分,用于制药、营养食品、食品和饮料以及化妆品部门。Averix Bio确保从种子到货架的一致质量,形成了建立在可追溯性、透明度和信任基础上的公司基础的基石。由拥有数十年cGMP和制药经验的世界级团队领导,Averix Bio的使命是为世界各地的患者带来更健康的基于大麻素的医疗解决方案。欲了解更多信息,请访问www.averixbio.com。 ### 媒体联系人 凯文·鲁道夫 阿韦里克斯生物 @averixbio.com +1 919.432.4548 罗杰·弗里登森,4月 伪造通信 @forgecommunications.com +1 919.349.3206

以上中文文本为机器翻译,存在不同程度偏差和错误;偶尔因源网页结构局限,内容无法一次完整呈现。请理解并参考原站原文阅读。

阅读原文