BCHT is mainly committed to the R&D, production and sales of innovative biological drugs for prevention and control of infectious diseases. Through independent research and development, our company has gradually established five key technology platforms, including virus scale-up technology platform, final product and adjuvant technology platform, genetic engineering technology platform , bacterial vaccine technology platform,mRNA Vaccine Technology Platform. These platforms are complementary to exert a strong synergistic effect, enabling more economical and efficient development of vaccine products and construction of vaccine portfolios. They are helpful for tackling the key industrial technologies, experimental studies of key processes, research on industrial technical standards, cultivation of engineering and technological innovation talents, and promoting the application of major scientific and technological achievements. Based on above platforms, our company has formed following product layout: Three vaccine products approved for market, more than ten key vaccine research projects under progressing steadily and abundant follow-up ladder products.
1.Virus culture scale-up technology platform
On the virus culture scale-up technology platform, virus culture on a large scale is realized in a suitable culture system, mainly including: cell factory or bioreactor for cell culture to prepare viral vaccines.
The virus culture scale-up technology platform is based on human diploid cell and Vero cell culture technologies. On this platform, with larger cell culture area per unit volume, high virus yield can be guaranteed; optimal cell and virus culture conditions have been defined through research. Rely on the application of this technology platform, Varicella Vaccine, Live has launched on the market, Herpes Zoster Vaccine, Live has got the production approval in Jan.2023.
2. Final product and adjuvant technology platform
Final product refers to drug products that are made in certain required dosage forms to be used for the target population to meet their needs of treatment or prevention. For vaccine products, which are biologically active, the main dosage forms are freeze-dried and liquid dosage forms; reasonable dosage forms can help achieving the efficacy and maintain the stability of vaccines.
An adjuvant is a non-specific immune enhancer which, when delivered together with an antigen or in advance into the body, can enhance the immune response of the body to the antigen or change the type of immune response. The commonly used adjuvants currently include aluminum adjuvant, MF59, etc. BCHT has gradually established a final product and adjuvant technology platform with years of efforts in design and characterization of new vaccine adjuvant systems and optimization of formulation process, compatibility evaluation between adjuvant systems and specific antigen candidates, optimization of combination of antigen and adjuvant systems, research on immunization strategies and evaluation of immune protective effects.
Benefiting from the deep research on protectants, BCHT has successfully developed the globally first Varicella Vaccine, Live with a validity period of 36 months. For the Influenza Vaccine, Live, Nasal, Freeze-dried, BCHT is developing the liquid dosage form in order to increase the convenience of administration. At present, PhaseⅠ,Ⅱclinical trials have been finished for this product, and its formula of protectants has obtained internationally patented. After nearly 3 years of exploration, a Nano-aluminum adjuvant has been developed. It has been applied in the diphtheria, tetanus and acellular pertussis combined vaccine for which Phase Ⅰclinical trials has been finished and in the process of validation and samples preparation of Phase Ⅲ clinical trial. Nano-aluminum adjuvant will also be applied in RSV etc. The Nano-aluminum adjuvant will also be used in RSV and other vaccines. BCHT has developed the BK-01 adjuvant as well, which is already used in the development of split-virion influenza vaccine. The establishment of the final product and adjuvant technology platform provides a basis for the marketing of other vaccines in the future.
3.Genetic engineering technology platform
Genetic engineering, theoretically based on molecular genetics and using modern molecular biological and microbiological methods, is the process of constructing recombinant DNA (rDNA) molecules in vitro with genetic materials from different sources and introducing these molecules into stromal cells or bacteria to obtain recombinant biological products.
The genetic engineering technology platform mainly includes technologies for nucleic acid vaccine preparation, expression of virus-like particles in E. coli system, expression of fully human monoclonal antibodies in CHO cells, baculovirus-insect cell expression system and other technologies. This platform has been applied to introduce optimized antigen genes into vectors, develop key technologies and construct an application platform to research and develop for major diseases such as malignant tumors, Alzheimer’s disease, tuberculosis, pneumonia, etc.; carry out the construction, evaluation, and development of novel therapeutic and preventive candidate vaccines such as DNA vaccine, mRNA vaccine and viral vector vaccine,etc.
Relying on this technology platform, BCHT is developing vaccine for Alzheimer’s disease, fully human anti-rabies virus monoclonal antibody, fully human anti-tetanus toxin monoclonal antibody and other preventive and therapeutic products.
4.Bacterial vaccine technology platform
Bacterial vaccine technology is used to develop bacterial vaccines and produce them on a large scale with extracted bacterial polysaccharides and toxins after large-scale bacterial culture in fermentation tanks. On the bacterial vaccine technology platform, polysaccharide protein conjugate vaccines as bacterial polysaccharide-protein carrier complexes to present enhanced immunogenicity are also possible by protein glycan coupling technology.
On this platform, purification schemes specific to the physicochemical properties of polysaccharides or toxins are designed, covering salting out, phenol extraction and alcohol precipitation, and chromatography processes; toxins are be detoxified by inactivators to obtain toxoids; large-scale bacterial fermentation and polysaccharide and protein purification technologies are all common core technologies for bacterial vaccines and genetically engineered vaccines that use bacteria as the production substrate. By virtue of this platform.
5. mRNA Vaccine Technology Platform
As a biological frontier technology and platform technology, mRNA technology can be applied to the prevention of infectious diseases, the treatment of tumors and protein replacement therapy. With the advantages of fast research and development, high safety, good immune protection effect and convenient production etc., mRNA technology has become an important technological development trend in the field of vaccines and biological drugs. In recent years, mRNA technology has made a breakthrough in the field of infectious disease vaccines, so mRNA vaccines have a large market space and development potential in the prevention and treatment of infectious diseases.
The company signed an investment agreement with Chuanxin Biopharmaceutical (Suzhou) Co., Ltd., with Chuanxin's core advantages in mRNA vaccine research technology, BCHT accelerate the construction of mRNA platform technology and expand applications; Improve the system of intellectual property rights related to the mRNA vaccines; Develop mRNA delivery technologies suitable for different purposes; On the basis of previous research, guided by the national strategies and market demands, the company gives full play to the advantages of mRNA technology, focuses on the research of cancer therapeutic vaccines and other infectious disease preventive vaccines in a rhythm, which promotes the realization of the diversification of products and technologies, and further improves the company's research and development strength and sustainable development ability.