Lebanon, New Hampshire – August 22, 2017 – Avitide, Inc., the industry leader in the discovery and development of exclusive affinity purification resins, announced ISO 9001:2015 certification for its Affinity Resin Manufacturing facility as of July 20th, 2017. Avitide was awarded the certification from Bureau Veritas without any non-conformities or requests for action.
The International Organization for Standardization ISO 9001:2015 is the most recent and comprehensive standard for quality management systems. It provides companies a framework for developing a management system that aligns quality with the broader business strategy. The standard focuses on risk-based assessment and accountability across all organizational processes and promotes effective communications, efficiency, and implementation of continual improvement initiatives. By meeting these comprehensive standards, Avitide assures its ability to consistently provide high-quality affinity resins to support the manufacture of multiple drug substances for its partners.
“The objective was to build a resin manufacturing facility, quality system, and operational team that will allow Avitide to consistently provide high-quality affinity resins that exceed our partners’ expectations. In doing so, we have combined state-of-the-art manufacturing features that enable highly responsive service timelines, ensure security and continuity of supply, while providing regulatory support of our affinity resin products. The manufacturing facility is characterized further by a highly flexible scale of operation, while maintaining consistent production of high-quality affinity resin products. We are excited for this achievement and its validation of what Avitide is able to deliver to our biopharmaceutical partners,” said Grant Espie, Avitide’s Head of Manufacturing.
“Avitide is now an end-to-end provider from ligand discovery to affinity resin manufacture. More importantly, we are able to supply this within our partners’ preclinical and clinical development timelines. Building affinity resin manufacturing capabilities that meet industry standards was a logical next-step to support our partners,” said Kevin Isett, Ph.D., Avitide’s Co-Founder and Chief Executive Officer.
Avitide discovers, manufactures and supplies molecule-specific biopharmaceutical affinity purification solutions with an industry-leading 3-month service timeline. Avitide’s proprietary affinity separation technology enables its partners to achieve faster bioprocess development timelines, reduced program risk, predictable commercial scalability, and lower cost of manufacturing for batch and continuous operations. Avitide’s high-resolution affinity resins can be designed to select and enrich for improved drug safety, potency, and quality attributes critical to controlling target product profiles and establishing biosimilarity. Avitide also delivers exclusive biomanufacturing intellectual property with its technologies. Avitide’s affinity purification platform has revolutionized biopharmaceutical drug purification and has been successfully deployed against an array of bio-molecules such as enzymes, bispecific antibodies, non-antibody therapeutics, recombinant vaccines, and gene therapies for capture and drug substance-selective applications. Avitide’s management team brings substantial expertise and a track record of success in commercializing innovative biopharmaceutical discovery and manufacturing technology platforms. Avitide is financed by premier venture capital and private equity firms such as Polaris Venture Partners, OrbiMed Advisors, Mithril Capital Management, Sands Capital Ventures, SV Health Investors, NeoMed Management, and Borealis Ventures.
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Bureau Veritas is a world-leading provider in testing, inspection and certification. Created in 1828, the Group has 73,000 employees in around 1,400 offices and laboratories all across the world. Bureau Veritas helps its clients to improve their performance by offering services and innovative solutions in order to ensure that their assets, products, infrastructure and processes meet standards and regulations in terms of quality, health and safety, environmental protection and social responsibility.
For more information, see Bureau Veritas website at http://www.bureauveritas.com/.
MacDougall Biomedical Communications