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Technology Platform
Empowering innovation in-house
Integrated and fully-fledged
Validated through the development of HPV and COVID-19 vaccines

Structure-Guided Antigen Design Platform

Protein structure heavily influences its function. Structure-guided antigen design features the use of protein structure in the design of vaccine antigen to render the antigen physicochemically more favorable, biologically more active and pharmaceutically more potent. The strengths of structure-guided antigen design lie in precise engineering and optimization of antigens in accordance with atomic-level protein structure information. The company has built a well-established structure-guided antigen design platform, based on which the company has designed desirable antigens for HPV vaccines, a recombinant COVID-19 vaccine and an RSV vaccine.

Protein Engineering and Expression Platform

Protein expression can be a tricky business due to the various forms, properties and structures proteins present. Successful product development relies on the choice of protein expression system in addition to optimizing the coding sequence of the protein of interest and engineering the expression vector as needed. The company has developed an advanced protein engineering and expression platform encompassing Ecoli, yeast and CHO expression systems that can be applied to the research and development of recombinant protein vaccines. On the strength of this platform, the company has successfully engineered and expressed at high levels the antigens of three HPV vaccines, a recombinant COVID-19 vaccine and a recombinant norovirus vaccine.

Vaccine Engineering Platform

Manufacturing recombinant vaccines is a complex journey, involving fermentation, protein expression and purification, formulation, quality control and fill-finish, all of which are very specialized and require trained professionals and well-equipped facilities. Meanwhile, the vaccine industry is highly regulated, and vaccine production has to comply with applicable laws, regulations and guidance, thus demanding huge capital investment to build manufacturing plant compliant with regulatory requirements. The company has established a vaccine engineering platform featuring a GMP-compliant pilot plant with an area of over 3,000 m2 that is well equipped for manufacturing and quality control. Scaling up bioprocesses for all development candidates can be accomplished in the pilot plant, which eases the transition into full scale commercial production in the future.

Potency Evaluation Platform for Recombinant Protein Vaccines

Potency evaluation is an essential component of quality control for vaccines. The choice of a suitable potency evaluation assay is linked to the mechanism of action of the vaccine product, and shall be able to rule out those immunologically inferior candidates in preclinical studies. Various procedures, including animal-based in vivo potency assays and in vitro relative potency assays，may be used for potency evaluation, the establishment of which represents a special challenge due to the unique compositions, multivalency and long life-cycle of vaccines. The company has developed sophisticated vaccine potency evaluation methods, including pseudovirus based neutralization assays, blocking antibodies assays and sandwich ELISA assays that are applied to the development of HPV vaccines, a recombinant COVID-19 vaccine, and a recombinant norovirus vaccine.