One of the goals of the alliance it to build an extensive Biological Reference Material Library (BRM) that can be accessed by industry partners, and regulators
The alliance will bring together industry leaders, regulators and consumers for the development of new industry testing standards using reliable, affordable DNA-based tools.
DNA
DNA barcoding offers a lot of potential for botanical testing, and is incredibly reliable, but only when performed on appropriate material. Botanical extracts are problematic because, while some extracts may contain DNA, it is often of low quality or degraded to a point that makes it impossible to perform proper authentication.
Other limitations of DNA technology are that, i) it cannot determine between plant parts (leaf, stem, root – the DNA is the same), ii) it’s not totally quantitative, and iii) there is not a definitive library of reference standards.
“We need to fill out the libraries and develop the probes,” Dr Steven Newmaster, Professor, Botanical Director, Centre for Biodiversity Genomics, told NutraIngredients-USA during a visit to the University of Guelph in late 2016. “The challenge for industry is when you have the technology before the standards. It would move the industry faster to work together on this.
“We’ve been talking to some of the big players and they’re excited by this. We need a group of people who can dedicate their efforts to that vision. The long-term goals are for industry to have a safe place to say, “We have this problem. Does anyone else have that?””
Research Alliance
DNA technology
The technology dominated trade media headlines in 2015 and early 2016 after NY AG Eric Schneiderman used it to build cases against a number of retailers of herbal supplements. The New York Times reporter Anahad O’Connor has stated that it was his coverage of Dr Newmaster’s 2013 research (published in BMC Medicine) that led AG Schneiderman’s office to launch its investigation into herbal supplements.
“You need to test everywhere in the supply chain, from suppliers to manufacturers to distributors to retailers, and this only works when you have a test that’s fast, onsite and cheap,” Dr Newmaster told us. “We need quick tools, to test every batch, and we’re trying to find a way to make it affordable to test every batch.”
Dr Newmaster’s team has been testing analytical solutions from a number of providers. “There are now tools that fit in the palm of your hand with a smart phone. The whole thing costs about $5,000 and gives you results in about 30 minutes at a cost of $50-100 per sample. This uploads the data direct to the cloud. In ten years it will be $1 per sample,” he said.
Guelph has been DNA barcoding for over 20 years, and has over 120,000 voucher samples in its herbarium, and 65,000 species of natural health products.
While some may point to GenBank – the NIH’s database that collects all publicly available genetic sequences – as a library for sequences, Dr Newmaster notes that there is no voucher samples and it is not curated. “It’s not an acceptable reference standard,” he said.
“We need one database that relates to the standards,” he added. “We’ll create it and build it.”
Goals
The Alliance’s short-term goals over the next five years are:
• Provide global leadership, vision and manage R&D goals that unify stakeholders and industry leaders into an alliance focused on the use of molecular diagnostics (MD) in quality assurance (QA) of natural health products (NHPs);
• Support manufacturing facility on-site MD testing with rigorous QA testing capabilities for screening adulterants and validating species ingredient authenticity.
• Develop a comprehensive SBRM DNA library, which could be mirrored within specific industry partners, academia and public organizations.
• Complete and distribute MD lab Standard Operating Protocols (SOPs) to industry partners, with eventual publication in USP monographs.
• Support MD lab capabilities within founding industry partners; advise on setting up on-site molecular diagnostic capabilities for equipment, software, reagents, BRM database, herbaria and voucher curatorial methods.
• Offer training programs for technical employees, new regulatory compliance (FISMA, USP verified, TRU-ID), suppliers, distributors, members and consumers; we feel that it may be important to educate and inspire Alliance members as they are on the front lines dealing with customer inquiries on quality assurance.
• Advance commercial Next Generation Sequencing (NGS) capabilities for screening adulterants using a validated quantitative approach that considers incidental DNA; small amounts of plant DNA that are of no concern because it does not comprise NHP quality.
• Co-develop with industry a new molecular diagnostic standard for NHPs, which will be embraced by industry, certified by TRU-ID and verified by USP, FDA, and Health Canada.
• Co-author journal publications of Alliance R&D with leading industry researchers, academics and regulators (USP, FDA, Health Canada).
• Host an annual Alliance conference for sharing accomplishments and charting industry and regulatory goals for the next year.
The longer term goals over 5-10 years are:
• Continue to provide global leadership, vision and manage R&D goals that unify stakeholders and industry leaders into an alliance focused on the use of MD in QA of NHPs.
• Ongoing support of manufacturing facility R&D needs for on-site MD testing with rigorous QA testing capabilities for screening adulterants and validating species ingredient authenticity.
• Curate a comprehensive SBRM DNA library for over 1000 ingredients including known adulterants.
• Innovate a portable hand-held MD testing capabilities at low cost ($1/test in minutes); built from NGS and oxford nanopore technology R&D during years 1-5.
• Co-develop with industry quantitative tools for assessing adulteration and counterfeiting of finished products including extracts in the distribution chain; portable, real-time testing linked into a data QA management system.
• Robust risk assessment QA models built on real data within the research Alliance.
• Co-author journal publication of Alliance R&D with leading industry researchers, academics and regulators (USP, FDA, Health Canada).
• Host an annual Alliance conference for sharing accomplishments and charting industry and regulatory goals for the next year.
Dr Newmaster confirmed that his team have not yet had conversations with any US-based trade associations in regards to supporting the Alliance, but now that they are near public launch it is likely that they will be reaching out in the coming months.
