Two new partnerships to drive sustainable delivery systems for the pharmaceutical industry

Croda International Plc (Croda) today announced that it has signed two new partnership agreements that will help the pharmaceutical industry move towards a more sustainable supply chain for vaccine adjuvants. 

The first partnership is an exclusive license agreement with Amyris, a leading synthetic biology company, for the supply of biotechnology-derived, pharmaceutical grade squalene used in adjuvants to boost immune responses. Squalene is commonly sourced from shark liver whereas Amyris’ sustainable squalene is derived from sugarcane, providing an identical molecule with higher purity. 

The second partnership is with Botanical Solutions Inc (BSI) to produce a sustainable pharmaceutical grade QS-21 vaccine adjuvant which enable the production of next generation adjuvant systems for new vaccine development. Today, QS-21 is produced by harvesting mature soap trees to extract QS-21 from the bark, whereas BSI’s adjuvant is derived from plant tissue culture.

Daniele Piergentili, President Life Sciences at Croda, explains his excitement: “Our partnerships with Amyris and BSI are fully aligned with Croda’s commitment to be the most sustainable supplier of innovative ingredients across our growth markets and with our pharmaceutical strategy to “Empower Biologics Delivery”. Our ambition is to be able to offer vaccine developers the most appropriate adjuvant systems to maximise the efficacy of their antigen. These sustainably-sourced technologies are a perfect extension to our broad spectrum of cGMP vaccine adjuvants, and we eagerly look forward to leveraging it globally across our customer base”. 

Under the terms of the first agreement, Amyris will manufacture and supply squalene to Croda and Croda will license squalene technology from Amyris to market, distribute, and sell squalene as an excipient, or as an ingredient in formulated products for use in human and veterinary vaccines, drug delivery systems, or nucleic acid delivery systems. Croda will also leverage its experience with good manufacturing practices (GMP) for the pharmaceutical industry and accelerate commercialisation of the final packaged squalene products to its broad customer base.  

John Melo, President, and Chief Executive Officer of Amyris, commented "We are pleased to partner with Croda to increase access to our sustainable squalene. Amyris currently supplies 70% of the world’s squalane market, saving 2.7 million sharks a year. With Croda’s partnership we believe we can have a similar impact on the vaccine market with our squalene.”

The Amyris licensing agreement coincides with news that Croda has entered into a strategic collaboration agreement with BSI to build a sustainable, scalable supply chain for QS-21. This is a potent vaccine adjuvant used in several innovative adjuvant systems, to enable vaccines against diseases such as shingles, malaria, and TB, plus promising new therapeutic vaccine and immunotherapy treatments, such as for cancer.  

BSI has developed a novel technology to grow Quilaja Saponaria, which promotes the production of QS-21 in laboratory conditions. This delivers the most sustainable source of QS-21, using plant tissue culture in contrast with conventional methods that harvest mature trees to extract QS-21 from the bark. 

According to Gaston Salinas, CEO at BSI, “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 sustainable GMP QS-21.”These announcements are in line with Croda Pharma’s strategy to “Empower Biologics Delivery” and follows news on investments, earlier this year, to expand Croda Pharma’s global manufacturing capabilities to enable the next generation vaccines and therapeutic drugs.