Discovery
With deep understanding and excellent experiences, we have built a comprehensive and innovative technology platform portfolio, which demonstrates our R&D capabilities and drives our continued development of next-generation vaccines.
Currently, our technology platforms are focused on three areas which we believe are the most innovative and promising for vaccine development, namely, DNA vaccines, protein subunit vaccines and adjuvants.
Technology Platforms
DNA Vaccine Platform
DNA Vaccine Platform
Our in-house proprietary protocol is established to develop, design and optimize DNA sequences for vaccine development, providing a standardized and scalable platform for the continued development of DNA vaccine products.
We believe it is an effective way for leveraging resources that we own our strong CMC processes to ensure the production of DNA vaccine with world class quality, purity and yield.
Advantages of DNA Vaccine
The purity of supercoiled pDNA we manufactured can reach more than 97% compared to FDA standards of 85%. Through next-generation processes and testing technologies, we are able to achieve high recovery rates for plasmid production and ensure the high quality of our vaccine products. Comparing to many other vaccine technologies, DNA vaccines have a key competitive advantage of the ability to stimulate both B cells and T cells, which generally translates to a strong immune response.
Protein Subunit Vaccine Platform
Protein Subunit Vaccine Platform
Through our years of knowledge and experience build-up in protein design and identification, particularly in combination with adjuvants, we have developed a profound understanding of protein structure and profiles in different viruses. This has enabled us to better develop vaccine products that target or utilize specific proteins and that are used in combination with adjuvants to enhance immunogenicity. We have developed an E. coli-based expression system, which enables high expression of proteins, and in turn translates to better immunogenicity of our vaccine candidates.
Moreover, using E. coli as host is more cost-effective compared to cell culture systems used by many major vaccine development platforms. Our protein subunit vaccine manufacturing process includes innovative extraction and purification technologies that ensures a high purity level for certain difficult-to-produce proteins. Moreover, our protein subunit vaccine manufacturing process is streamlined and robust, which is suitable for efficient scale-up for commercial production.
Adjuvants
Adjuvants
Traditionally, adjuvants are used in conjunction with vaccines to help the host’s immune system to recognize the pathogen and amplify the magnitude of immunoresponse against the pathogen. We have developed innovative adjuvants that not only enhance CD8+ cytotoxic T cell functions, but also can act as immunomodulators to induce Treg cells to control overreactive T cells. Our adjuvant platform primarily includes three key technologies, namely, adjuvant in vitro screening system, cell-guided adjuvant screening and adjuvancity animal test. By applying these technologies in sequence, we are able to screen, analyze and evaluate potential adjuvants for particular purposes with speed and accuracy.
Commercial-Ready Manufacturing Facilities
A commercial-scale manufacturing facility located in Suzhou industrial park with a total gross floor area of approximately 18,000 square meters.
A research and development center with a gross floor area of approximately 2,500 square meters, powered by advanced equipment and instrument and a biosafety Level 2 laboratory facility.
Acquired Suzhou Si’ao in the third quarter of 2020.
Our manufacturing facility meets GMP standards and we recently obtained vaccine manufacturing permit.
Advanced Manufacturing Process
We have commercial-ready manufacturing facilities and advanced manufacturing process. For example, we have developed advantageous DNA vaccine manufacturing process. The proprietary manufacturing technologies we hold and our cell culture media, enables the manufacturing process to be more streamlined, scalable, cost-effective, stable and easy to control.
Our clinical team has extensive experience with clinical affairs in China and globally, take advantage of strong understanding of polices, to develop our differentiated clinical strategy and the schemes. The clinical development department is also accountable for the management of the medical- related and operation related issues through the clinical development process, including enrollment management, follow up and drop out, safety issue handling, quality compliments and audit.
In cooperation with numerous hospitals and principal investigators located in China, Australia and South America that can support our clinical trials of different indications at different stages, our clinical team tight controls of multiple factors including suitability of onsite facilities, availability of qualified staff and availability of research subjects, to exploit the potential of geographic diversity of these facilities which are able to provide us with a significant advantage in implementing large-scale clinical trials and to conduct multiple clinical trials concurrently.
Furthermore, we have engaged external experts as primary investigators of our clinical trials. Conducting clinical researches with safety steering, protocol reviewing, external and internal governance to safeguard patient safety.
Trial Production in Suzhou Plant
We expect to commence pilot production in the second quarter of 2021 and are expected to produce vaccine samples for our phase III clinical trial and bridging trials for pGX9501 in the second quarter of 2021 in our manufacturing facilities in Suzhou. We expect to complete stage I of our manufacturing facilities at our Suzhou manufacturing base in the second quarter of 2021, which will enable us to be commercial-ready for the anticipated launch of our COVID-19 vaccine. We have obtained vaccine manufacturing permit.
Brand New Equipment
Our manufacturing facility is equipped with brand-new equipment and instrument. Our production equipment includes fermentation system, disc centrifuge, ultrafiltration system, chromatographic system, formulation system, and auto-packaging and filling machinery. Many of our major manufacturing equipment are manufactured by leading international and domestic brands such as GEMU, Labom and Siemens.
We Have a Professional Team
We had a manufacturing team of 40 employees, which is led by Dr. Dan LIU, who has more than 15 years of experience in manufacturing biological products, including vaccine products. Our manufacturing team is further categorized into various departments based on our manufacturing process, including production management, solution production, preparation production, quality assurance, quality control, validation, procurement and logistic, and engineering and equipment department.
We are committed to the development and protection of intellectual property rights. We recognize the importance of intellectual property rights to our business and are committed to the development and protection of our intellectual property rights. We actively seek patent protection for our vaccine candidates in China and certain major jurisdictions and file additional patent applications, when appropriate, to cover certain antigens, strains, proteins, formulation and production process. We have developed a significant portfolio of intellectual property rights to protect our technologies and products.
