The production base of TOT BIOPHARM has been completed and put into operation.
DNA, the basis of all life on earth, has a twisted double helix structure. In TOT BIOPHARM a hollow spiral staircase from the first floor through the third floor, sunlight through the roof of the glass, warm and cheerful, this is the second phase of TOT BIOPHARM. Project - wan upgrade other monodrug production base, May 24 in suzhou industrial park was officially completed and put into operation, the grand ceremony and a successful conclusion.
Many leaders of suzhou park government, guests from domestic and foreign biomedical industry, academia and investment sector, as well as all employees of TOT BIOPHARM. attended this grand ceremony and witnessed this exciting and important moment together.
The established monoclonal antibody production base is an important effort and practice made by TOT BIOPHARM. in response to the made in China 2025 strategy, integrating advanced biotechnology with high-end manufacturing technology, accelerating industrial upgrading, and improving production equipment, technology, products and quality standards. 2012 TOT BIOPHARM pharmaceutical completed the first phase of the factory, after opening continued to strengthen capital and expansion, actively promote the transformation and upgrading, the second phase started construction in October 2016, the production base includes prefi lled needle preparation production line (ADC) and antibody coupling drug products business scale of freeze-dried precincts, configuration than the raising of the scale of cell culture production line, the single production capacity can reach 16000 L, resistance is one of domestic large-scale industrialization base biopharmaceutical industry. The completion of the base marks the completion of the use of dongyao pharmaceutical industry to biological industry upgrading once again took a solid stride.
TOT BIOPHARM pharmaceutical single drug resistant production base in the second phase reserved when the design capacity expansion and adjustment of space, the production base has officially after the operation, combined with the existing level of 500 L biological medicine pilot platform, can satisfy the biological medicine from upstream r&d, pilot production to drug clinical trials and commercial production demand, but at the same time or alternately production more than 10 different kinds of antibody drugs, can produce a total of hundreds of kilograms. At the same time, it will also provide high-standard MAH/CMO/CDMO services for domestic and foreign pharmaceutical companies to promote the development and upgrading of domestic bio-pharmaceutical industry.
At present, China is comprehensively deepening reform, promoting innovation and entrepreneurship, and providing new opportunities for enterprise development. Biological drugs, especially monoclonal antibodies, have important value and position in the field of cancer and other major diseases. The production base with industrialization capacity and high efficiency and excellent production capacity will help provide high-quality drugs to patients at reasonable prices, reduce national medical costs, and greatly increase the competitiveness of domestic drugs in the world.
Focus on cancer, source innovation
Visit east yao pharmaceutical general manager huang chunying
Focus on cancer prevention, focus on source innovation
TOT BIOPHARM. (hereinafter referred to as "dongyao pharmaceutical") is a high-tech enterprise of biomedicine, which originated from Taiwan and specializes in r&d, production and marketing of anti-tumor new drugs. At the very beginning of its establishment, Ms. Huang chunying, the general manager, has been working in the field of anti-tumor for nearly 30 years and has rich experience in the development, production and sales of new drugs. In the past 8 years, under the leadership of general manager of huang chunying, TOT BIOPHARM has accumulated enough energy, put down roots, driven by innovation, and become a shining new star.
"Anti-tumor is a very special field, and the deeper we go, the more we can't get away from it," said Ms. Huang. Cancer research is closely related to life and health. Cancer patients not only undergo great changes in physiology and psychology, but also affect their families and friends. Therefore, dongyao pharmaceutical was established in the field of anti-tumor, specializing in therapeutic biological products, anti-tumor chemicals and special dosage forms, and established the company's vision of "improving the quality of life of cancer patients worldwide with innovative technology".
Focusing on the source innovation of drugs and adhering to the enterprise spirit of "professionalism, innovation, care and speed", dongyao has always established a core technology platform with global intellectual property rights. So far, dongyao pharmaceutical research pipeline a total of 10 varieties, three key technology platforms have a number of authorized invention patents, has been declared in China 7 IND, including 4 monoantibodies and 3 chemical drugs, 6 varieties of clinical approval, the fastest progress has entered the clinical phase III stage.
Build a comprehensive industrial platform, layout of the entire industrial chain
TOT BIOPHARM pharmaceutical current project is based on the result of "frontier and target mechanism together", considering the heterogeneity and variability in the field of tumor are large, diversified treatments, TOT BIOPHARM pharmaceutical industry is committed to providing the product combination, the combination of different medicines or diagnosis and treatment of drug combination, let the doctor have more choice, let patients have more opportunities. At present, the company has built a domestic leading technology platform for anti-tumor drugs integrating oncolytic virus, therapeutic monoclonal antibodies, antibody cross-linking drugs and key technologies of special dosage forms of liposomes.
The completion of the single drug resistant production base - phase ii workshop is in accordance with the requirements of GMP, advanced facilities of antineoplastic drugs industrialization base, a total construction area of 13000 m2, configuration than the raising of the scale of cell culture production line, for the first time to increase the production capacity directly by 50 L to 2000 L, at the same time, the cell culture area can hold 8 2000 L POTS, once an production capacity can reach 16000 L, at the same time for more than 10 kinds of single production, is one of domestic large-scale industrialization base biopharmaceutical industry, while improve capacity utilization, shortened the working time, Reduced production costs.
In addition, the plant is planned to have a production line for prefilling needle preparations and a commercial scale freeze - drying area for ADC products. It is reported that at present, there are about 10 manufacturers of antigen-coupled drugs in China. Therefore, dongyao pharmaceutical has a very competitive advantage in this aspect .
In terms of research and development, dongyao pharmaceutical currently has the key core technologies such as large-scale cell culture (2000 L), amplification and the isolation and purification of monoclonal antibodies, which are advanced in China. In terms of production, dongyao pharmaceutical has built a workshop of about 10,000 m2 in the first phase of the project, including 2 chemical drugs oral workshop, 1 injection workshop and 1 500 L scale biological drugs pilot workshop, with unique preparation technology. The onolytic virus workshop has also obtained the bsl-2 certification, which is rare in China.
Strengthen cooperation and innovation
"Adhere to the market demand as the guide, national policy for guidance", after 8 years of development, TOT BIOPHARM pharmaceutical in infrastructure construction, team construction, the construction of platform technology emerged, to build the international level, experienced talent team, build the two complete, high quality of the drug product line and four platforms of cash. From the front-end research and development, production, and marketing, a diversified product portfolio of 1+1> and 2 has been formed, making the product chain play the greatest benefit.
In terms of platform, under the leadership of general manager chunying huang, dongyao pharmaceutical has formed "innovative drug research and development platform, manufacturing platform, drug market license holder (MAH) cooperation platform and marketing platform". In 2017, TOT BIOPHARM. and suzhou pioneer pharmaceutical co., ltd. were formally approved by the state food and drug administration (CFDA) to push forward the application for MAH registration of a chemical 1.1 new drug variety. This is the first MAH pilot variety approved by CFDA in jiangsu province. In 2017, TOT BIOPHARM was successively awarded as "national technology advanced service enterprise", "foreign investment research and development center of jiangsu province", "suzhou industrial park annual economic contribution outstanding enterprise", "ten most socially responsible enterprises in suzhou industrial park", "2017 biological industry most valuable investment enterprise" and "cross-strait rehabilitation BBS public welfare award".
Strategic development of anti-tumor drugs, strengthen cooperation in innovation. In the future, dongyao pharmaceutical will further promote the company's commercial strategic cooperation, to make high-quality and affordable drugs. In the face of cancer this changable opponent, east yao pharmaceutical with the attitude of continuous innovation, always keep growth, learning and flexibility of the inherent, the courage to challenge, and strive to achieve "let cancer patients body and soul well-being" the ultimate value goal.