uct Name	QS-21
Chemical Name
CAS No.	141256-04-4
NMPA CDE registration no.	F20250000075
USFDA DMF No.	041805
Quality grade	Injection
Quality standards	Conforms with USP, EP, JP, ChP standards
Molecular Formula	C92H148O46
Applications and examples	QS-21 has been used in SHINGRIX, Mosquirix, Arexvy and other commercially available vaccines developed by GSK.
Product code	B01001
Package sizes	100mg
Storage condition	Transport: At 2-8°C. Long-term storage: Sealed, protected from light at 2-8°C. Avoid: Exposure to strongly oxidizing agents. Retesting: Annual requalification required.

QS-21 is an immunostimulatory saponin, capable of stimulating both humoral (Th2) and cell-mediated (Th1) immune responses, and promoting antibody production and antigen-specific T cell responses. It activates dendritic cells (DSs), promotes the production of IgG1 and IgG2a antibodies, and induces the secretion of interferon-γ (IFN-γ). Additionally, QS-21 enhances the function of cytotoxic T lymphocytes (CTLs), thereby combating various infectious diseases and cancers. 

However, traditional QS-21 has faced dual constraints of capacity and purity due to limitations in extraction processes. AVT has successfully developed a proprietary separation and purification technology that enables efficient extraction of high-purity QS-21 from Quillaja saponaria. We have also established a stable, reliable quantitative analytical method for routine quality control, separation component analysis, and determination of component content, thereby accelerating the processes for product development and root cause analysis (RCA). 

QS-21 Advantages 

Leveraging our proprietary separation and purification technology platform, we have simultaneously separated components such as QS-7, QS-17, and QS-18, providing a more comprehensive QS series for vaccine development. In response to the need for higher safety standards in veterinary vaccine applications, we have manufactured high-purity QS-ANM. Relying on our separation and purification technology platform, we now have the capability to supply the full range of QS products and support customized product development, facilitating the vaccine development process.

QS series Product

Leveraging our proprietary separation and purification technology platform, we have simultaneously separated components such as QS-7, QS-17, and QS-18, providing a more comprehensive QS series for vaccine development. In response to the need for higher safety standards in veterinary vaccine applications, we have manufactured high-purity QS-ANM. Relying on our separation and purification technology platform, we now have the capability to supply the full range of QS products and support customized product development, facilitating the vaccine development process.

Product Name	Product Code	CAS No.	Molecular Formula	Molecular Weight	Availability
QS-21	QS-21-HP	141256-04-4	C92H148O46	1990.15	In stock
	QS-21-MP
QS-7	QS-7-HP	208933-54-4	C83H130O46	1863.89	In stock
	QS-7-MP
QS-17	QS-17-HP	N/A	C104H168O55	2298.43	Within 2 months
	QS-17-MP
QS-18	QS-18-HP	N/A	C98H158O51	2152.29	In stock
	QS-18-MP
QS-ANM	QS-ANM	N/A	N/A	N/A	Within 2 months

▪ Applications of QS-21 in clinical-stage vaccine programs

Active in 17 clinical indications, including non-small cell lung cancer (NSCLC), herpes zoster, melanoma (phase I clinical trial); Alzheimer’s disease, HIV, tuberculosis, Varicella Zoster, etc. 

▪ Applications of QS-21 in approved vaccines 

☑ Shingrix® shingles vaccine-GSK 

☑ Approved for marketing: in 2017 in the United States and Europe, and in 2020 in China; 

☑ Indication: for the prevention of herpes zoster (shingles); not for prevention of primary varicella. 

Category	Component	Content (per Dose)
Antigen	Varicella-Zoster Virus Glycoprotein E (gE)	50 μg
Adjuvant	Quillaja saponaria Saponin QS-21	50 μg
	3-O-Desacyl-4'-monophosphoryl lipid A (MPL)	50 μg
	Dioleoylphosphatidylcholine (DOPC)	1 mg
	Cholesterol	0.25 mg

AVT’s QS-21 dual China-U.S. regulatory filing marks a critical milestone in the globalization of China-developed high-grade vaccine adjuvants. We commit to continuous optimization through: 

☑ GMP-compliant adjuvant supply systems

☑ Customized development support

☑ End-to-end quality control services