R & D and services
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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.
