Avient Biosciences Adopts New Name to Signal Move to 21 CFR Part 210 and Part 211 Compliance
North Carolina-based company producing cannabinoid ingredients that meet pharmaceutical-grade cGMP criteria
Wilson, N.C., (July 30, 2021) — The largest industrial hemp research, extraction and production company in the eastern U.S. has adopted a new name, Averix Bio, to signal its emergence as the only 21 CFR Part 210 and Part 211 cannabinoid supplier in the U.S. Located in North Carolina’s Research Triangle region, the company formerly known as Avient Biosciences has a 200,000-square-foot facility on a 36-acre campus that includes pharmaceutical- and food-grade research and production suites, on-site analytical testing laboratories, and climate-controlled biomass storage facilities.
With the 21 CFR Part 210 and Part 211 compliance, the company will both partner with life sciences companies that are exploring the use of cannabinoids as an active pharmaceutical ingredient (API) and pursue its own finished pharmaceutical products to treat opioid addiction, epilepsy and trauma-induced mental health disorders.
“Our goal over the last 18 months has been to introduce a higher level of compliance and manufacturing rigor to cannabinoid production,” said Miles Wright, the company’s CEO. “Today’s name change to Averix Bio reflects us nearing our start as a manufacturer of products that are 21 CFR Part 210 and Part 211–compliant, a milestone that will help drive research, launch API and finished products, and collaborate with partners as a science-driven, risk-based manufacturer.”
Mr. Wright noted that the company’s quality assurance team has more than six decades of cGMP pharmaceutical experience, having worked on multiple products at GlaxoSmithKline, Pfizer, Novartis, Roche and Genentech, from clinical Phase 1 through commercial production.
That experience provides peace-of-mind for premier pharmaceutical manufacturers that need batch samples, “seed-to-shelf” tracing and high levels of compliance.
“Essentially, we want to be the ingredient partner of choice for people doing medical-grade research on cannabinoids anywhere in the world,” said Mark Ward, vice president of sales and marketing. “We’re interested in medical breakthroughs using cannabinoids. There are a lot of sharp minds exploring how these ingredients can be part of potential treatments for a broad range of health issues, from acne to Crohn’s Disease to cancer, but there’s still much more research to be done.”
Today’s announcement comes on the heels of several key process-, market- and regulatory-related milestones for Averix Bio. The company has expanded its footprint to provide pharma- and food-grade cannabinoid products to clients in the EU and South America and plans to keep its North Carolina headquarters as its operational hub as it partners with potential pharmaceutical manufacturers in new markets.
“We were strategic in our decision to locate near Research Triangle Park because of its global reputation for leading pharmaceutical research, our ability to source high-quality hemp directly from North Carolina farmers, and the access we’d have to a technical, highly skilled workforce,” Mr. Wright said. “Those same three dynamics are poised to make North Carolina, in our view, a worldwide force in cannabinoid research in the years ahead.”
Founded in 2018, Averix Bio offers a wide array of high-quality cannabinoid ingredients to global pharmaceutical, nutraceutical, food and beverage, and cosmetic companies that are ready to leverage the anecdotal health and medical benefits of CBD in their products.
“While we’re changing our name, our mission remains the same: We’re a science-first company dedicated to advancing the therapeutic benefits of cannabinoids,” said Mr. Wright. “Our clients’ successes will benefit patients, and that’s ultimately where our greatest successes will be found.”
About Averix Bio
Averix Bio is in process to be the first botanical-based cannabinoid research and extraction company in the U.S. producing 21 CFR Part 210 and Part 211-compliant products. 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 cGMP/pharmaceutical experience, Averix Bio is on a mission to bring healthier cannabinoid-based medical solutions to a global consumer market. For more information, visit www.averixbio.com.