Tianjin Institute of Pharmaceutical Research (TIPR), which owns more than ten key laboratories and engineering research centers, including State Key Laboratory, Tianjin Key Laboratory, Tianjin Engineering Research Center, has established a series of technical service platforms and formed an integral industrial chain of pharmaceutical research and development, and has the capacity to carry out the research work of innovative drugs, generic drugs, biopharmaceuticals, and new formulations. TIPR is now taking great strides on the road of pharmaceutical research and development.

Research and Development of Small Molecular Innovative Drugs

Research Centre of Innovative Drug of Tianjin Institute of Pharmaceutical Research, with an integral chain of innovative drug research and development system, consists of a series of research teams covering drug targets analysis and identification, molecular design, compounds synthesis and screening, active pharmaceutical ingredients (APIs) preparation process and quality standard research, formulation and preparation process research, as well as non-clinical evaluation including pharmacodynamics, pharmacokinetics and safety, and clinical protocol design and drug registration. The Research Center can carry out interdisciplinary and multidisciplinary cooperative research work of innovative drugs.

Biotechnology and Biopharmaceutical Research and Development

The Biotechnology Center of Tianjin Pharmaceutical Research Institute is a comprehensive biotechnology research platform with product development and transformation functions, focusing on the introduction, development, innovation and application of new technologies and the industrial transformation of biotechnology and biopharmaceuticals as its research objectives.

The center focuses on the current and future emerging areas of new drug development and clinical application, such as multi-specific antibody drugs, advanced vaccines, antibody conjugated drugs, fusion proteins, gene therapy, etc., in order to build a research and development platform for the entire industrial chain, accelerate transformation and upgradation, and enhance enterprise value. The center has complete facilities for molecular biology, cell biology, immunology, radioisotope, and high immunodeficiency animal feeding; The center is equipped with advanced instruments and equipment including real-time label-free cell analyzer, digital PCR, fluorescence quantitative PCR, gel imaging, and tissue and cell library management system. Moreover, the cell product and biological drug pilot production lines under construction will provide new impetus for the development of the center

Research and development of traditional Chinese medicine

Research and development of traditional Chinese medicine

Tianjin Institute of Pharmaceutical Research (TIPR) has been committed to the innovative research and development (R&D) of traditional Chinese medicine (TCM) for decades, with a comprehensive discipline layout, including process research, formulation research, quality analysis, pharmacodynamic evaluation, safety evaluation, etc. TIPR has strong advantages in talents, technology, software and hardware, and leads the level of corresponding research in China.

Through many years of innovative research, TIPR independently developed 41 new drugs of traditional Chinese medicine, which access to new drug certificate and industrialization. Among them, 39 original varieties, 33 exclusive varieties, and 27 varieties were included in the medical insurance catalog, covering 23 major and common diseases in the fields of cardiovascular and cerebrovascular systems, respiratory systems, etc. These achievements meet the needs of therapeutic drugs for major clinical diseases and make great contributions to improving the level of medical health. For independently developed new drugs, the annual sales of two varieties exceed 1 billion, and eight varieties exceed 100 million. In the recent three years, the cumulative sales reached 31.18 billion, with the newly-added profit reached 2.18 billion, and the direct economic benefit reached 11.24 billion, which greatly promoted the development of industrialization. All 41 new drugs have been industrialized in 24 provinces in China, and relevant key technology services radiated to 32 provinces, which played a huge role in promoting the product structure adjustment and industrial technology upgrading of Chinese medicine industry.

After years of R&D practice, TIPR has formed a technology system for the whole life cycle of Chinese medicine products, covering new drug discovery, drug property research, preclinical research, clinical evaluation, industrial transformation, and post marketing secondary development. The established technical platforms are as follows.

TCM Innovative Drug R&D Platform:

This platform mainly based on the theory of TCM, and oriented to meet clinical and market needs. It undertakes the development of innovative drug with compound prescriptions, effective parts and active ingredients.

Classic Prescription Drug R&D Platform:

This platform undertakes the new drug innovation and technology projects, related to classic prescription, and cooperates with enterprises to carry out research on classic prescription drug and key technologies.

Modern Chinese Medicine Preparation Technology Platform:

Relying on the national and local joint engineering laboratory of modern preparations and quality control for TCM, it establishes key technologies and product development systems, such as dripping pills, soft capsules, effervescent tablets, sprays and aerosols, gel ointments, quick-disintegrating tablets and sustained-release tablets, etc.

TCM Quality Control Technology Platform:

Relying on the Tianjin key laboratory of quality markers of traditional Chinese medicine, it undertakes systematic research on quality control methods and quality standards featuring TCM quality markers, and establishes a series of key technologies and quality evaluation system for TCM quality control.

The API R & D Center

The API R & D Center of Tianjin Institute of Pharmaceutical Research is established with the idea of internationalization, professionalization and specialization. Its high-end generic medicine research focuses on the development of APIs in the psychoneurological, metabolism, and tumor drugs fields. Meanwhile, CDMO and CMC businesses of chemical innovation drugs have been carried out. Owing to high barriers in developing the high-end technology platform, low-cost imitation of APIs and its own high-tech barrier platform, the Center has distinguished itself from other domestic enterprises.

With years of capital investments, technical research and practical experience, the API R & D center has formed a project operation system of scientific management and a sound organization, trained a scientific research team with master’s degree as the main body and built a new product technology development platform for the process safety evaluation and green chemistry which includes flow chemistry technology, enzyme chemistry & asymmetric catalysis technology and analytical department. A project development system that integrates higly research, production sales is established based on two manufacturing factories, namely the Tianjin Taipu Pharmaceutical Co.,Ltd and the Tianke(Jingzhou) Pharmaceutical Co.,Ltd.

Pharmaceutical research and Development

Taking the research of pharmaceutical preparations as the main development direction, it undertakes the preparation-related research work of “State key laboratory of drug delivery technology and pharmacokinetics”, “Tianjin engineering research center of pharmaceutical preparations technology “, and ” Tianjin engineering research center of consistency assessment for generic drugs “. In response to major needs for the development of the pharmaceutical industry, formulation design in new drug discovery, research on key technologies and common technologies related to pharmaceutical preparations, and formulation engineering research were carried out. It possesses strong scientific research strength and rich experience in the research and development of dosage forms such as tablets, capsules, granules, oral solutions, injections, injection emulsions, freeze-dried powder injections, inhalants, gels, etc. The main research directions are oral poorly soluble drug formulation technology, targeted drug delivery formulations, sustained-release formulation technology, compound formulation technology, micro-active drug formulation technology, unstable drug injection technology, innovative drug formulation technology, preparation technology for parenteral administration, consistency evaluation of Generic drug. Equipped with complete small-scale, pilot-scale and industrialized preparation equipment and professional testing instruments, it can undertake the research and development industrial technology transfer of chemical generic drugs, innovative drugs, and new preparations.

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