Jiangsu Haoke Bioengineering Co., Ltd. (hereinafter referred to as Jiangsu Haoke) is a professional supplier of cell culture products. It is mainly engaged in the research and development, production, sales and technical services of animal derived series products and cell clinical application serum-free medium series products. The company specially invites American biotechnology experts and senior technical design masters in the German industry to work together to design and establish an advanced production line with an international ranking in top single digit in Jiangsu Taizhou pharmaceutical high-tech park in accordance to cGMP standards.
In addition to the investment to establish product research and development center in the United States, we also joined operations with our raw material suppliers in Australia and South America committed to production and supply of animal-derived products for biopharmaceuticals, vaccines, and biological scientific research in China. We aim to provide a stable and traceable high-quality animal derived products for the biomedical enterprises and scientific research institutes in the future, to ensure the high quality of products and the authenticity of biological scientific research results and provide stable raw material guarantee for the further development of the customer in the global market.
Furthermore, our R&D center in the United States has successively developed serum-free series and xeno-free culture medium with high safety and reliable quality for clinical application of biological cell therapy comparable to international brands. These products have been put on record by the Medical Device Technical Evaluation Center of the State Drug Administration.
Jiangsu Haoke focuses on cell culture only:
- Animal-derived products - fetal bovine serum, newborn calf serum, calf Serum, etc.
- Biological cell clinical application series products - CAR-T, NK, MSC serum-free & xeno-free medium and cryopreservation, etc.
Jiangsu Haoke can provide complete qualification certificates for the above series of products, etc., from raw material collection to production to finished product supply, all processes are standardized, traceable and perfect. At the same time, we can also provide customized production services for enterprise customers with different needs according to customer requirements.
At the beginning of its establishment, Jiangsu Haoke specially invited well-known German bio-industrial design masters to participate and guide the design of our factory and production line. Later, Nanjing Medical Engineering Design Institute was hired to design and build the current workshop based on the original European standard drawings combined with domestic regulatory requirements.
Jiangsu Haoke has introduced disposable production equipment (process) that currently ranks in the single digit in the world (a total of 4 independent production lines, which means that our production equipment is mainly linear equipment, except for auxiliary equipment). At the same time, a professional production management software is implemented to customize our the production process. The production process follows cGMP standards - there are clear regulations from raw material testing, product production, finished product testing, warehousing and storage, and the entire process can be traced. In addition, our company currently uses all imported raw materials for production, and according to different sources, the raw materials are stored separately from the warehouse and produced in separate workshops to completely avoid and eliminate any cross-contamination that may occur during the production process.
At present, our company has passed the ISO 9001 quality management system certification. And the existing products have completed the DMF registration license and the first-class medical device production and filing certificate in the State Food and Drug Administration.
Life Sciences
Healthcare
Cell Engineering
Vaccine & Pharmaceuticals
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