Offering Broader Access to Sustainable and Scalable Pharma-grade Saponin Adjuvants

10/13/2023

SPI Pharma, Inc. and Q-Vant Biosciences, Inc. announce a strategic partnership which includes an investment to expand Q-Vant's proprietary 100% sustainable Q-SAP™ technology, and the signing of an exclusive commercial agreement to accelerate global adoption of their high-purity saponin adjuvants for veterinary and human vaccine formulations.

SPI Pharma, Inc. (SPI) and Q-Vant Biosciences, Inc. (Q-Vant) have partnered to leverage Q-Vant's leadership in unique, sustainable saponin extraction technology with SPI's global pharmaceutical reach and expertise in servicing the industry. The investment commitment to expand commercial-scale GMP manufacturing of high-purity saponins, along with the exclusive commercial agreement, will enable global pharma customers to access a sustainable, scalable, and fully integrated supply of saponin adjuvants.

Quillaja saponin-based adjuvants, including QS-21, are considered the "Gold Standard" of adjuvants for enhancing immune response to vaccine antigens. They are a vital component in more than 17 human vaccine candidates, including the FDA-approved GSK Shingrix® shingles vaccine, the WHO-authorized GSK Mosquirix® malaria vaccine and GSK's recently approved Arexvy® RSV vaccine. In addition, saponin-based adjuvants have shown promise in a number of veterinary vaccine candidates, and they are a key component of vaccines used to eliminate outbreaks and control the spread of foot-and-mouth disease. However, these vaccines have been created with saponins from resource-constrained sources, creating potential supply chain risks and limiting their use in new vaccine developments.

Q-Vant has over a decade of saponin purification and sustainable Quillaja sourcing experience, combined with installed sustainable and scalable biomass technology as well as significant investments in high density plantations, cell culture technology and greenhouses. Q-Vant has solved the challenges of unsustainable saponins and finally created a supply chain which will be capable of supporting billions of doses of saponin-based vaccines per year. SPI brings experience and focus on pharmaceutical solutions including innovation, quality and regulatory expertise, logistics, and global customer support. The addition of Q-Vant's sustainable saponin adjuvants to SPI's portfolio of parenteral products will solidify SPI's leadership in the space.

"Q-Vant is excited to be partnering with SPI and we look forward to working closely with them. The expertise of SPI's scientific and quality teams combined with the strength of its global sales network will allow us to accelerate the development and market acceptance of our innovative and fully sustainable saponin-based adjuvants," said Doug Klaiber, CEO and Co-founder of Q-Vant.

"The combined expertise of this partnership with Q-Vant will create a unique solution provider to vaccine developers and manufacturers globally. The high quality, fully integrated sustainable supply of saponin adjuvants is a perfect addition to further enhance our portfolio and meet the needs of our pharmaceutical and veterinary customers," added Scott Thomson, CEO of SPI Pharma.

About SPI Pharma, Inc.
SPI Pharma, headquartered in Wilmington, Delaware, USA, provides innovative products and technical solutions to global pharmaceutical customers. Product lines include Vaccine Adjuvants, Drug Delivery Systems, Antacid Actives, Taste Masking and Excipients. SPI Pharma specializes in drug development services, having participated in over 60 commercially launched and marketed drugs globally. With its sites in the United States, France, and India, the company solves the most challenging formulation problems –– efficiently, cost-effectively, and with a focus on service. For more information, visit www.spipharma.com

About Q-Vant Biosciences
Q-Vant is a privately held biosciences company that has solved the supply chain problem of QS-21 and other Quillaja-based saponin adjuvants for the global human and animal pharmaceutical markets. The company's next-generation technology platform combines computational learning techniques with a proprietary multi-step purification process to increase the supply of QS-21 by more than 1,000 –enabling the production of billions of doses annually to meet today's increasing global market demand. Led by a team with unrivaled experience in vaccine and adjuvant development, manufacturing and global regulatory requirements, and with world-class knowledge in Quillaja saponin supply chain, agronomy, extraction and purification, Q-Vant is the first company that is vertically integrated to combine a secured sustainable Quillaja raw material supply with pharma cGMP commercial-scale production of QS-21 and other saponin-based adjuvants. For more information, visit www.q-vant.com.