As close to nature as possible

Most experts agree that producing a botanical-based product requires excellent raw material that has been sustainably and ethically grown. But that is only the first step. Raw materials and their active compounds are especially sensitive to handling and processing, so choosing a supplier that adheres to strict guidelines for good manufacturing practices and has deep expertise is also important.

A case in point is Ixoreal Biomed, the India-based producer of KSM-66 ashwagandha root. Ashwagandha root extract is all the company does. Their system took more than a decade to develop and acknowledges the holistic nature of medicinal plants like ashwagandha, respecting their naturally evolved and balanced matrix of compounds and phytochemicals that produce health effects in the body.

The goal is to make it as natural as possible, but KSM-66 goes well beyond that.

The company has achieved 42 third-party quality certifications that independently verify the safety and quality control measures they take and the validity of their raw materials. This includes certifications that cover good manufacturing practices from groups like NSF International and WHO; food safety and quality certifications, such as the U.S.-based FSMA Foreign Supplier Verification Program; those dealing with food sensitivities or dietary standards, such as gluten-free, kosher and halal; organic certifications in the U.S., Canada, European Union and India; and verifications regarding quality management systems from the International Organization for Standardization.

All of these processes and certifications were of great interest to the team on the recent tour of KSM-66 operations in India. The group had reached the second leg of their journey, traveling from Rajasthan, the seat of ashwagandha cultivation, to Hyderabad, a thriving, modern city in the state of Telangana in Central India, and home to the KSM-66 Ixoreal Biomed ashwagandha root production facilities. The day included an extensive tour of one of its four state-of-the-art manufacturing facilities, including a warehouse and analytical laboratory.

The tour helped make the connection between the farm and all the stages in between from storage to processing, noted William Clark, MSc., Ph.D., global R&D lead, physical and mental wellness, consumer health for Sanofi. “We saw the bags of ashwagandha root come into the warehouse and then from there all the steps of the processing through the extraction process,” he said. “It was very well organized in terms of flow and in terms of manufacturing process. You might expect some large manufacturing facility, but it is the right size; very efficient and very high volume in terms of production.”

What impressed Charles Norton, co-founder and product director at UK-based brand Wild Nutrition, was the complexity and stringent processes the company has in place. “Obviously, they don’t need to be pharmaceutical grade, but they decided to do that way ahead of time, planning for the future, adopting the very best practices possible to ensure they are creating the very best possible quality of end product,” he said.

The tour is an illustration of where tradition intersects with science, noted Maibritt Johnsson of Swedish brand Medicine Garden, a company that produces products based on ayurvedic tradition and clinical research. This is one of the keys for their company, she said, adding “when you see the whole chain and come to the plantation, to the farms, you can see that they do it the right way—the traditional way.”

From storage to extraction

The group witnessed the multistage process, which begins with testing the raw materials for 525 pesticides, then washing the ashwagandha roots in purified water and drying the roots in warm air ovens. The dried roots are then pulverized to a specific particle size for extraction. Ixoreal Biomed’s novel clean, green extraction process took 14 years to perfect and utilizes both traditional extraction methods and modern extraction and distillation technologies to yield a final product that is standardized to 5% withanolides.

The concentrated extract is then poured into trays for drying. The company now uses two drying methods. One is tray drying that takes about four days and turns the extract into a hard cake, which is again chopped and sifted into the right particle size. This is considered one of the best methods and is preferred for high-density capsules and tablets.

The other method is spray drying, which evaporates the extract almost immediately. The spray dryers are customized exclusively for Ixoreal Biomed, meeting the company’s exact specifications. Spray drying generates a fine powder and is generally preferred for products like functional beverages that require high solubility.

Most of the group is not new to touring supplement manufacturing facilities, and they understand how integral these steps are to their finished product. “When I look for botanicals, I look for something that’s as close to nature as possible,” said Max Willis, chief innovation and science officer at Better Being Co. (formerly Nutraceutical Corporation). “What you want to do is find a product that keeps all the active principles—the full spectrum of the plant—present,” he explained. “A lot of herbs come in and if they are not treated properly or if they are stored in a hot warehouse, they can become spent herbs, or inactive. All you have is some root fibers, but where are the withanolides, where are the active principles?”

When you make an extract, you can lose a lot of the active principles, Willis continued. “What KSM-66 does is they not only start with farming the plant in an organic way, but the way they extract it and process it keeps all the fibers and active principles of the plant intact. And that’s what impresses me.”

“What I also learned here,” Willis added, “is that a lot of herbal extracts are spray dried onto non-value-added carriers, like cellulose or maltodextrin. This is a pure herb that doesn’t use any extra fillers. So, it’s basically washed, extracted and the finished product is 100% ashwagandha root.”  

Beyond the clean processing, Ixoreal Biomed also does extensive testing, which is especially important for an herb like ashwagandha, noted Elijah McCarthy, N.D., director of product development at Irwin Naturals. “Ashwagandha is something that consumers can take on a daily basis. Because of that, it is important that quality and purity of material is at the highest standard. If somebody is going to be consuming it on a daily basis, you don’t want there to be even a trace amount of toxicity or any sort of contamination because over time that could build up and become a big issue,” he said.

These measures not only offer peace of mind but illustrate the importance of having a partnership with a supplier who is well-aligned with your brand’s value proposition. “The integrity with which we started our business was always about starting with the very best ingredients that we could find to give to our customers,” Norton explained. “When it cost more, it didn’t matter; it was about providing the very best product.”

In fact, he added, “Off the back of this trip, it has really made me readdress our entire ingredient choices as a brand…It is something we have already done, but I want to really double down and make sure that we have a much better understanding of that full supply chain.”

Click here to read part one and two of this four-part series.