BravoVax has established the quality system following the cGMP pertains to key regulatory bodies like NMPA, EMA and WHO. The technical platforms of vaccine production and testing have laid a technical foundation for product development and industrialization. These platforms supplement each other to form a strong synergy effect, which enable the vaccine products and portfolios to develop in a more economic and efficient way, providing solid guarantee for new products to launch into the market.
Technical platforms for vaccine production
Technical platform for polysaccharide and polysaccharide-protein conjugate vaccines
Based on the experience of 13-valent Pneumococcal Conjugate Vaccine (PCV-13) that has already secured clinical trial authorization, BravoVax established technical platform for polysaccharide and polysaccharide-protein conjugate vaccines, including fermentation, preparation of polysaccharide, preparation of vector protein, protein purification, as well as technology of conjugation and adjuvant adsorption. With the use of this platform, multi-valent and combined bacterial vaccines (include Hib, MCV, DPT etc) could be further developed.
Technical platform for adenovirus vectors
BravoVax boasts both technical platform for Human adenovirus type-5 vector and Chimpanzee adenovirus vector, thus vectors could be selected for the development and production of various vaccines as per demands. BravoVax has independent intellectual property for this platform. Based on it, the pipeline could be extended to CDMO business, and abundant technical platforms could be further established.
Technical platform for attenuated and inactivated vaccines
BravoVax possesses both diploid fetal rhesus monkey lung cells (FRhL-2 cells) (exclusively owned in China) as well as Vero cells, thus cell lines could be selected based on the type of vaccine products. And the technical preparation platforms for attenuated vaccines and inactivated vaccines on the strength of cell lines are established, which can be employed in the most of attenuated vaccines and inactivated vaccines for fast development.
Technical platform for recombinant protein
BravoVax has established a recombinant protein platform for both prokaryotic and eukaryotic expression systems. Project 601 uses E.coli expression system, and covers the processes from antigen design, sample preparation, high-density fermentation, to purification development and optimization. Meanwhile the platform for prokaryotic expression system has tackled the major obstacles in inclusion body refolding and endotoxin removal.
BravoVax possesses the technical platform for eukaryotic expression system, such as CHO expression system. Transient expression and purification for recombinant protein could be achieved in this expression system, which could be applied for preparation of samples for animal study and antigen.
The two expression systems could be selected based on the type of antigens, and the pipeline could be extended further to CDMO business.
Technical platform for formulation
BravoVax has facilities for prefillable separator, vials separator, lyophilizer etc. The formulation of various vaccines have been developed, and platforms for injection and inhaler are established based on this, which can be employed in preparation, filling and lyophilization for various vaccines.
Technical platforms for vaccine control tests
Technical platform for bioassays
BravoVax has built technical platform for virus titer determination, including TCID50, IFA, PFU, ICC etc.; platform for virus identification, including molecular biological identification (PCR, qPCR, etc.) and immunological identification (serum neutralization test, western blot, etc.); platform for biological residual detection, including residual of host DNA, host protein, RCA, AAV, etc. All these platforms are based on a comprehensive process of methodology establishment, verification and transfer, and have been successfully applied in vaccine production. A certain part of the test assays have been verified by NIFDC, and can be used in other similar products.
Technical platform for immunoassays
BravoVax has developed the technology for humoral immunity evaluation, including test for titers of binding antibody and neutralizing antibody, such as ELISA, SPR, TRF, etc.; technology for cellular immunity evaluation, including cytokine assay and cell proliferation assay, such as ELISPOT, FCM, etc. The company also has technical platforms for pseudovirus and antibody preparation.
Technical platform for biochemical assays
BravoVax has built technical platform for physiochemical assays on samples/impurities, including chromatography, particle size, PI, UV, NMR, etc.; platform for biochemical assays, including Biacore, SDS-PAGE, Western Blot, Southern Blot, Dot Blot, etc.; platform for detecting residual of detergent and organic impurities in small molecule including Triton X-100, Tween, IPTG, DDT, antibiotics, etc.
Technical platform for PoC in animal models
BravoVax has utilized contract animal houses to develop and establish a series of platforms for proof of concept (PoC) in animal models, including Intragastric administration of oral rotavirus vaccine in rats and mice, different administration routes of injectable vaccines, nasal spray of adenovirus, etc. The company has also built challenge evaluation in animal models for HPV vaccine, providing critical supporting data for the feasibility study of the vaccine.
Technical platform for gene editing
BravoVax possesses proprietary intellectual property rights on technical platform for preparation and manufacturing of CRISPR/Cas ribonucleoprotein (RNP), and has established one-stop solution for high-efficient gene editing, vaccine design and modification as well as gene therapy based on this platform.
BravoVax also possesses proprietary intellectual property rights on platform for molecular detection technology of CRISPR, which can be used to develop a variety of rapid detection kits for POCT of viruses, pathogenic microorganisms and hazardous substances.