MF59-like Adjuvant (Product Name: WGa01 Adjuvant)
WGa01 Adjuvant is a squalene-based oil-in-water emulsion adjuvant manufactured using the same production process as MF59 adjuvant. It can be incorporated into recombinant protein vaccines, subunit vaccines, inactivated vaccines, and other vaccine types to enhance the body's adaptive immune response to antigens. We are currently offering complimentary samples and welcome inquiries to establish commercial collaborations (including "Adjuvant-Vaccine Co-Development" and "Adjuvant Production Technology Transfer") to jointly accelerate the R&D and registration of innovative adjuvant-vaccine products.
WestVac Biopharma's MF59-like Adjuvant (WGa01) Collaboration & Service Models — Providing Full Lifecycle Support for Innovative Adjuvant-Vaccine Development
1.Free adjuvant samples with usage guidelines for vaccine-antigen compatibility studies
2.Regulatory support for adjuvant-related documentation in clinical and registration stages
3.Co-development and/or contract manufacturing of adjuvant-vaccine products for clinical trials and commercialization
4.Custom adjuvant production for commercial-scale orders
5.Technology transfer services for GMP-compliant adjuvant production facility setup
6.Retail supply of adjuvants in multiple specifications (10mL, 20mL, 100mL, 10L, 20L) for research institutions and vaccine developers
Specifications and Features of MF59-like Adjuvant (WGa01)
1）Market-Proven with Guaranteed Safety
1.In 2023, the trivalent and monovalent recombinant COVID-19 vaccines (Sf9 cell) using WGa01 adjuvant from WestVac Biopharma were granted emergency use authorization in China.
2.Real-world data from hundreds of thousands of vaccinated individuals confirm excellent safety with no severe adverse reactions reported.
2）Fully Independently Developed, No Patent Infringement
1.This product is a squalene-based oil-in-water adjuvant with technical specifications similar to the original Novartis MF59 adjuvant.
2.The original Novartis MF59 adjuvant patent has expired, ensuring this product is free from FTO (Freedom-to-Operate) issues. A non-infringement legal opinion from McCarter & English, LLP is available upon request.
3）GMP-Scale Production Ensures Stable Supply and Guaranteed Quality
1.A GMP-compliant large-scale production facility has been established, featuring two 500-liter batch production lines with an estimated annual output of 365,000 liters.
2.Dozens of GMP production batches have demonstrated minimal inter-batch variability, meeting international quality standards comparable to MF59 adjuvant, while achieving lower production costs at scale.
3.Manufactured under strict GMP guidelines, this adjuvant has a shelf life of three years, with long-term stability studies confirming excellent performance even beyond this period.
4）Poised to Become China’s First Approved Novel Adjuvant
1.WestVac Biopharma’s squalene-based adjuvant in its recombinant COVID-19 vaccine is currently under regulatory review, positioning WGa01 to potentially become China’s first commercially approved novel adjuvant.
2.Upon regulatory approval of WestVac’s WGa01-adjuvanted vaccine, this adjuvant is expected to be included in the CDE (Center for Drug Evaluation) excipient filing list.
5）Collaborative Development to Accelerate Market Entry
1.Under confidentiality agreements, complimentary adjuvant samples are available to reduce development time, eliminating redundant pharmaceutical studies and shortening R&D and time-to-market.
2.WestVac Biopharma offers technology transfer services (including GMP production line setup) to clients (MAHs) to ensure sustainable adjuvant supply.
3.Partnerships have been established with dozens of domestic vaccine manufacturers/R&D institutions, and adjuvant technology has been shared with CEPI (Coalition for Epidemic Preparedness Innovations) to support global innovative vaccine development.
MF59-like Adjuvant (Product Name: WGa01 Adjuvant) Squalene-based Oil-in-Water Adjuvant
