Botanical Solution and Croda Pharma inks agreement to accelerate production for GMP QS-21
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Botanical Solution and Croda Pharma inks agreement to accelerate production for GMP QS-21

QS-21 in blockbuster Shingles vaccine, first vaccine approved for Malaria, promising RSV phase III candidate, and Covid-19 applications.

  • By IPP Bureau | December 01, 2022

Botanical Solution (BSI), innovator of sustainable, consistent and cost-effective Advanced Botanical Materials (ABM) for agricultural and pharmaceutical applications, has entered into a Partnership Agreement with Croda Pharma to build a robust, scalable and truly sustainable supply chain and deliver kilogram-quantities of QS-21 to the pharmaceutical industry.

BSI and Croda Pharma are announcing this Partnership Agreement at the World Vaccine and Immunotherapy Congress West Coast 2022 in San Diego this week.

QS-21 is a highly efficacious vaccine adjuvant. It is used in the blockbuster vaccine Shingrix for the prevention of shingles, which has been found to have 10 years of durability. QS-21 is also used in a malaria vaccine, a COVID vaccine and promising vaccine candidates for tuberculosis and RSV. Increasing demand for QS-21 will continue to put pressure on the traditional supply chain for this adjuvant.

QS-21 is traditionally extracted from a tree native to Chile known as the Soapbark tree (Quillaja saponaria). However, there are regulatory restrictions on deforestation of this tree, while projected demand for QS-21 is in the billions of doses annually and increasing.

BSI’s proprietary and scalable manufacturing processes produce QS-21 according to pharmaceutical specifications without sourcing raw materials from forests or plantations. To accomplish this goal, the Company relies on its plant tissue culture platform for production of high quality Quillaja saponaria biomass (ABM) with a consistent yield of QS-21. BSI’s commercially proven tissue-culture platform and ABM are the basis for the Company’s award-winning product Quillibrium®, distributed by Syngenta in multiple countries in Latin America.

According to CEO Gaston Salinas, “BSI and Croda Pharma are natural partners with a shared vision on removing the barriers that have prevented mass adoption of QS-21 for developing highly efficacious modern vaccines. Through this very exciting partnership we aim to supply kilogram-quantities of a truly sustainable GMP QS-21.”

Regarding Croda’s Partnership Agreement with BSI, Peter Tygesen, Croda’s Head of Adjuvant Business commented, “BSI’s unique and innovative processes for growing Quillaja Saponaria biomass in their labs and then extracting the QS-21 from these young plants is a game changing approach. We look forward to partnering with BSI and creating a robust, scalable and sustainable supply chain for QS-21, enabling our customers to work with this gold standard vaccine adjuvant.”

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