PHARMACEUTICALS
The big change, Salinas says, has been BSI’ s ability to make its own enduse product, relying on proprietary purification processes.
“ The main reason for following that route is that we found out while we were working on scale-up that there was a major flaw in the downstream manufacturing process,” Salinas explains. There was also a sustainability issue: to generate the product at kilogram scale for billions of doses would have required heavy use of organic solvents and high disposal costs.
In 2024, BSI succeeded in developing new methods from hazardous organic solvents and was also more costeffective. It will still work with Croda to roll out the product, however. Salinas expects the first GMP materials to be made available to pharmaceutical companies in 2H 2025. He will make a more detailed announcement on this at CPHI Americas in Philadelphia in May.
The“ really exciting news”, he says, is that Croda is not only enabling BSI to accelerate the mass adoption of QS- 21 as a stand-alone compound but has also made significant investments in developing clinically relevant adjuvant systems that need QS-21 in order to work and are planning to make them available to other vaccine developers who might need them.
“ There is clear value that both parties bring to the table,” he says. This will address demand for highly efficacious vaccines in high-income countries, but the real long-term aim is make them available“ at the right price” for the malaria vaccines that he believes“ will change the face of underprivileged regions across the world.”
There has been quite a learning curve in getting into the pharmaceutical industry, Salinas agrees. The two are completely different in many ways, not least the economics of product development and securing approval, albeit that long timelines are involved for each. About the same level of effort and energy are needed but the price at which QS-21 is sold is orders of magnitude higher in pharma than agro.
Agro still important
BSI will still have“ a significant revenue stream” from the agrochemical business. Quillibrium is now being
BSI scientists discussing the use of Quillaja Saponaria in vaccines distributed by Syngenta in Chile and Peru, with Mexico to follow next year. Brazil is a big target, because the market is so big and registering a new biological is much quicker than in other countries in the region.
The US and then the EU, where already long registration timelines continue to grow, will be the next priorities. However, Salinas recognises the value of having a product registered in the EU.“ It is a long journey, but we are committed to making it happen,” he says. More details on a global distribution for Quillibrium are expected to be announced later this year.
The company is now looking at opportunities in other biocontrol products over the next five years, also working with different plant species, and is as close as it has ever been to registration and fieldtesting for these. To date, over 150 different species have been screened for biological activity, mostly also native to Chile. That is only the starting point, of course: registerability, the IP landscape and manufacturing challenges lie ahead before any compound can go towards commercialisation.
Some of the most promising are bioherbicides, bioinsecticides and bionematicides. The biofungicide market is already rather crowded and Salinas sees limited scope for developing new ones unless they clearly exhibit superior control and efficacy but looking for new bioherbicides“ is a big deal for us”.“ We are committed to keeping the agrochemical business running, but in terms of value creation and meeting investors’ expectations, what we are doing in the pharmaceutical space is what will have the greatest impact,” he says. ●
Gaston Salinas
CEO
BOTANICAL SOLUTIONS
J j gaston @ botanicalsolutions. cl www. botanicalsolutions. cl
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