(stock code: 834738) was founded in 2005 with registered capital of ¥67.3 million. It is a high-tech enterprise that engages in researching, developing and manufacturing biological medicines, chemical raw medicines, preparations, intermediates, and new drugs...
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2016/05/13
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2016/01/01
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2015/12/28
Led by three professional doctors, there are more than 80 personnel in the R&D center of Tianjin Minxiang Biomedical, among which, more than 40% are employees with at least three years of work experience, and about 30% have master’s degree or above. Our R&D center is composed of five teams: API group, process development group, pilot scale-up group, biological products R&D group, and quality research group. So that we could provide services of advanced pharmaceutical intermediates process development, API registration, enzyme fermentation and catalysis, products quality research and so on.
Equipped with thirteen liquid chromatographs, three gas chromatographs, one Agilent 7890-5977 single quadrupole GCMS, and one Agilent 6460 triple quadrupole mass spectrometer, our R&D center can provide research staff with strong analytical supports.
Our R&D center has over 6000m2 R&D laboratories and pilot workshops, including two pilot R&D workshops with kilo scale, 4 pilot manufacturing workshops and 2 API manufacturing workshops. Equipped with 20L, 50L and 100L glass reaction vessels, and over 90 sets of enamel reactors range from 100L to 3000L, our R&D center can meet the needs of process scale up step by step and scale-up manufacturing.
Since the R&D center establishment, we have already obtained over 60 independent intellectual property rights, including 3 patents for invention. With the expansion of our R&D team, our capabilities has also been affirmed by relevant departments. In 2013, our R&D center was recognized as the Enterprise Technology Center of Jinnan district. In 2015, our center was recognized as the Enterprise Technology Center of Tianjin city.
With the support of its scientific research ability and professional teams, Minxiang Biomedical has a successful track record of large-scale manufacturing and process improvement and upgrading of series products. Meanwhile, with the support of government policies on science and technology industrial parks of Jinnan District and Jinghai District, Minxiang Biomedical has built a R&D center led by professional doctors, and are ready to provide professional product customization service and technical solutions for domestic and foreign customers.
Minxiang Biomedical adheres to the strategy that the market developing and R&D supplement each other, and the domestic and international market go hand in hand. We can provide high-quality and qualified products for domestic and foreign pharmaceutical companies, fine chemical companies, and research and development institutions. The downstream and finished products of our products can make significant contributions to human health and environmental protection.
Tianjin Minxiang Biomedical Inc. is a national high-tech enterprise that integrates R&D and industrialization, mainly focusing on the advanced pharmaceutical intermediates and API research of adamantane derivatives, antiviral and anti-diabetic drugs. Beyond that, we also gradually industrialization our products, which brings us a strong advantage. At present, our R&D advantages mainly include:
1. Complete pilot and industrialization supporting facilities. The most important step during drug production from process development to large-scale manufacturing is pilot and industrialization research. Minxiang Biomedical has built 8 multi-functional pilot workshops, including 2 GMP workshops. Equipped with over 150 reactors ranging from 20L to 3000L, Minxiang Biomedical can provide specific reaction condition clients needed, such as cryogenic temperature, high temperature, anaerobic condition, hydrogenation, etc. In addition, we can also conduct the industrialization research on multiple projects with a scale of 1~80kg.
2. Rich experience in the process development of adamantane derivatives, antiviral drugs, -liptin and –liflozin drugs. With more than ten-year process-development experience in these fields, Minxiang Biomedical has strong technical and market advantages. We have successively completed industrialization research and realized large-scale manufacturing of dozens of pharmaceutical intermediates and APIs, such as 1-adamantanamine hydrochloride, memantine hydrochloride, 1,3-dimethyl adamantane, 3-amino-1-hydroxyadamantane, 1-adamantanol, vildagliptin, saxagliptin, sitagliptin, empagliflozin, timolol maleate, etc.
3. A technical team with extensive experience in APIs and pharmaceutical intermediates research and development. Different from industrial products, the process development of APIs and pharmaceutical intermediates requires experienced personnel in not only chemical synthesis, but also pharmaceutical research and quality control. Minxiang Biomedical has a professional technical team on API process development and quality research. Composed of dozens of personnel, this team is good at conducting pharmaceutical studies conforming to the guidance of drug registration, including overall quality strategy control of products, tracing and control of impurities, crystal form study, stability study, critical process parameters study. We also completed the development of 1-adamantanamine hydrochloride and timolol maleate, and acquired the certificate from NMPA. In addition, we provide pharmaceutical intermediates and APIs customized services to pharmaceutical companies as a CDMO, and regulatory services for API registration.
4. Enzyme catalysis and fermentation technological advantages. For chiral compounds and compounds with complex structures, enzyme catalysis and fermentation technologies have larger technical and market competition advantages than traditional chemical synthesis. Minxiang Biomedical has built a laboratory of independent screening enzyme activity and a pilot production workshop for enzyme fermentation and catalysis through years of hard work. Up to now, we have completed the industrialization study of couples of intermediates through enzyme fermentation and catalysis technology, such as saxagliptin, sitagliptin and other –liptin products.
