Industrialization of pharmaceuticals
The industrialization team has more than 30 senior experts in various aspects of the drug industrialization process, including production process development, analysis method development, GMP production and release management, non clinical management, clinical medical management, registration management, quality management, etc，Capable of undertaking all tasks related to drug CMC development and drug production management.Backbone employees have over ten years of business management experience, with two-thirds holding a master's degree or above. They have graduated from well-known universities both domestically and internationally, such as Purdue University, Tsinghua University, China Pharmaceutical University, and Shenyang Pharmaceutical University. The core personnel have many years of practical work experience in the development of upstream and downstream processes, analysis methods, GMP production and release testing, and GMP compliance management for AAV viruses and plasmids. They have worked for many well-known domestic and foreign pharmaceutical companies or biopharmaceutical companies such as Gilead, Staidson, Chengda Biotechnology, Four Rings Bio-Pharmaceutical, and Kawin.
Plasmid technology platform
Plasmids are key raw materials for AAV virus production, and high-quality plasmid construction and preparation are prerequisites for high-quality virus preparation. Based on the QbD concept and DOE experimental design method, develop plasmid fermentation process and plasmid purification process. From small-scale research to pilot scale, the fermentation plasmid yield can approach 1g/L.
The unique two-step chromatography of plasmids not only reduces the costs of chromatography packing, chromatography columns, chromatography solutions, and storage, but also benefits the scalability of the process and improves purification production efficiency. The difference between plasmid batches in production is small, with a superhelix ratio of over 95%, and other key quality attributes meet relevant standards.
AAV process platform
AAV virus production: Using a three plasmid co transfection system, HEK293 cells were cultured in serum-free suspension, and 3E14vg virus could be obtained per liter of scale. The full capsids purity of the harvested liquid can reach over 20%.
Virus purification: Based on the characteristics of AAV products, from the perspective of separation and purification theory, combined with advanced research trends and production processes in the industry, a platform purification process suitable for ophthalmic gene therapy drugs is designed, striving for a simple route, high purification efficiency, high purity of target products, and stable product quality. This not only ensures the smooth progress of research projects, but also provides strong support for the launch of new research and development pipelines in the future. At present, after purification process, the full capsids purity of the original liquid can reach over 90%, which has reached the advanced level in the industry.
The AAV purification process uses affinity chromatography to remove impurities such as host proteins and host DNA, followed by ion chromatography to remove empty shell viruses. After sterilization filtration and sterile filling, the drug is ensured to be sterile and safe. The overall process adopts advanced equipment and fillers, with simple operation and easy pilot scale.
The current purification process can make the AAV full capsids purity at the leading level in the industry, and other impurity residues can meet the requirements of multiple national pharmacopoeias and industry standards. Reduced the side effects of medication and provided safer protection for patients' medication.
Analysis technology platform
Our analytical department is well equipped with lEC-UPLC, ddPCR, microplate reader, fluorescence quantitative PCR instrument, etc. The scientists in the department are highly trained and experienced, and well qualified for developing and verifying these QC/QA methods and conducting sample testing that is required for AAV drug development and final product release.
Clinical and regulatory affairs
The founding team's years of clinical practice can provide sufficient support for the smooth implementation of clinical trials; Develop personalized and comprehensive clinical trial plans for each product to ensure the smooth progress of drug clinical trials.
Deeply understand laws and regulations, develop diversified declaration strategies, and assist in product industrialization. Based in China, with a global perspective, we actively promote the registration and application of our products both domestically and internationally to serve the vast number of patients.
CHIGENOVO Co., Ltd. is an ophthalmic gene therapy company, a national high-tech enterprise focusing on genetic diagnosis of genetic eye diseases and the development of gene therapy drugs. It is committed to providing "one-stop" services for patients with genetic eye diseases.
HUATAO GROUP
Contact us
Telephone:400-6006223 010-82071936
Website:en.chinagene.cc
Address: Floor 4, Area D, Building 1, No.27 Life Garden Road, Zhongguancun Life Science Park, Changping District, Beijing
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