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WorldPharmaToday.com / 19.04.2024 / For Botanical Solution Inc. – Join us in an insightful conversation with Botanical Solution Inc. (BSI) CEO as we explore their transformative journey in vaccine adjuvants utilizing Quillaja saponaria trees. From pioneering breakthroughs in plant tissue culture to forging sustainable partnerships with industry leaders like Croda International, BSI is reshaping the vaccine production landscape. Discover how their proprietary technology ensures a stable supply of QS-21 adjuvant, crucial for enhancing vaccine efficacy. With recent expansions in R&D facilities and successful funding rounds, BSI is poised to revolutionize vaccine development and global healthcare sustainability, as highlighted in our exclusive feature with World Pharma Today.
1. Give us a brief on how the transition has been since getting into the in-lab Quillaja saponaria trees, and what are the learnings you would like to take to your next step?
The main challenge was in working with in vitro plant tissue which was not originally designed for the mass production of QS-21. BSI not only discovered how to help these plant tissues to produce QS-21, but also how to get QS-21 accumulated in the plant tissue (biomass) at a scale that enables mass production of the compound from a truly sustainable source.
2. Tell us about the QS-21 adjuvant supply agreement with Croda International. How much of a role has sustainability played when it comes to getting into agreement with Croda?
BSI has an agreement to provide Croda with the botanical materials they need for pharma grade GMP QS-21 vaccine adjuvant to meet worldwide demand. Croda is committed to be the most sustainable supplier of innovative ingredients. This Commitment is reflected in Croda’s action plan for the decade to be Climate, Land and People Positive by 2030. The United Nations Sustainable Development Goals fed into the assessment of operations, products and services and goals have been defined to make the biggest positive contributions. They extend consequently to Croda’s procurement and sustainable sourcing. Using natural resources brings the responsibility to ensure there are no associated negative social or environmental impacts and an opportunity to advocate for and contribute to positive change. Our partnership actively implements SDG 17, Partnership for Goals, through collaborative initiatives and aligns with Croda’s ambition to be Net Nature Positive by 2030. Botanical Solution’s cutting-edge technology using plant tissue culture to produce Advanced Biological Material is a sustainable way to ensure supply of high-performing QS 21 needed for current vaccines and the development of the vaccines of tomorrow. This component is a fraction initially identified from bark extract from Quillaja saponaria Molina, a South American tree. Traditionally, mature trees are used to harvest the bark extract for further downstream processing and purification. This results in deforestation with a negative impact on the environment.
BSI and Croda have partnered to secure sustainable and consistent supply of a highly purified pharmaceutical grade QS 21 meeting the stringent requirements of the vaccine industry. QS 21 is a potent immunostimulatory component of adjuvant systems and used in licensed vaccines, for instance against shingles and RSV, as well as in many vaccine developments in clinical trials covering a broad spectrum of prophylactic and therapeutic vaccines. Securing access to this powerful component from a sustainable source has been essential for Croda to support their customers with sustainable solutions and thereby contribute to the successful development and licensing of WHO listed pipeline vaccines.
3. The proprietary and unique tech platform to grow Quillaja saponaria trees in BSI’s own labs has been a revolutionary step. How has QS-21 supply stability been achieved due to this?
BSI is committed to ensure a virtually unlimited supply of Advanced Botanical Materials for QS-21, meeting global demand. In addition to meeting global demand, BSI is making possible the much greater use of QS-21 in more and different kinds of vaccines in the future, thanks to major technology breakthroughs achieved by the Company recently that will decrease QS-21’s cost of goods dramatically. Currently, QS-21 is used in popular blockbuster vaccines, such as Shingrix for shingles, Arexvy for RSV and Novavax’s Covid-19 vaccine. However, by making the supply of QS-21 more plentiful and more economical, it will be possible for QS-21 to be used for other diseases, such as Malaria, which affect smaller, more remote populations in poorer countries.
4. The two new R&D labs and elaborated staffing in Davis, CA, point out the promise that Quillaja saponaria trees come with. What are the expectations from such an expansion?
BSI’s new labs in Davis, California are focused on the development of a “Super Quillaja” plant tissue specially designed for production of QS-21. This ground-breaking plant breeding program, in combination with improvements to QS-21 downstream manufacturing will pave the way towards the mass adoption of the gold standard vaccine adjuvant.
5. How did the Series A funding go considering the inroads that Botanical Solution Inc. went on to make with the lab-grown Quillaja saponaria trees?
Last year BSI closed its Series A funding for $13 million very successfully with a group of resilient and committed investors who embrace and support BSI’s vision to bring a truly sustainable QS-21 to the market. These investors are led by Otter Capital. During the second half of 2024 BSI will launch its Series B funding to further accelerate our progress.
6. Tell us something more about the Series B funding that is coming up. What are the expectations BSI has from it?
Series B funding will expand BSI’s manufacturing capacity under GMP for the production of pharma grade QS-21.
7. Late last year, you won the ICIS Chemical Business 2023 Best Process Innovation Award. Can you please let us know the parameters due to which you won this coveted title?
The Best Process Innovation Award from ICIS Chemical Business was one of four (4) industry awards BSI received during this recent 12 month period. The Best Process Innovation Award was presented to one small to medium- sized enterprise (SME) from among dozens of entries. BSI was recognized for its unique and proprietary method of “growing and extracting from plants in-the-lab to produce QS-21 vaccine adjuvant for human health.”
8. BSI went on to win the 2023 Best Product/Service of the Year Award at the UK’s Big Sustainability Award Competition. Tell us something more about that.
The UK’s Big Sustainability Awards is one of the world’s longest running program’s for recognizing companies that contribute to a better environment. Last year they honored BSI with what is arguably their top award … that of Best Product/Service of the Year. According to the judges, “This award is for an organization within any industry that has launched a physical product/technology/service within the last 12/18 months designed to support a sustainability strategy, or which offers a more eco friendly alternative to what is currently in the marketplace.”
9. Last year has been truly memorable. Discuss in detail the hits that BSI managed and what more can be expected this year.
Last year was BSI’s 10th anniversary since its start in 2013. During 2023, BSI advanced its first supply agreement with Croda Pharma to develop kilogram quantities of its in-lab grown and extracted advanced botanical materials for QS-21. We also completed our Series A funding for $13 million, won 4 industry awards, opened two new R&D labs in Davis, CA. (the first BSI labs outside of our first lab in Santiago, Chile), and we hired about 35 new BSI employees to accelerate us in reaching our goals. 2023 was an eventful year, but the best is yet to come.
