Analysis of the registration key points of biosynthetic and traditional microbial fermentation APIs
Release time:
2024-04-26 00:00
Source:
Synthetic biology can be understood as the engineering of biology, which is equivalent to deconstructing various basic biological components and then reconstructing biological systems with desired functions to produce various target substances. McKinsey predicts that by 2025, the economic value of synthetic biology and biomanufacturing may reach as high as 100 billion US dollars, and 60% of global material production in the future can be achieved through synthetic biology manufacturing. As a cutting-edge interdisciplinary subject, the scope of application of synthetic biology basically covers most fields, and has broad application prospects in the fields of medicine, health, manufacturing, agriculture, etc.
Microbial fermentation refers to the process of using microorganisms to convert raw materials into products needed by humans through specific metabolic pathways under suitable conditions. Since 1929, when A. Fleming discovered that staphylococci around contaminated Penicillium colonies were dissolved, and 1941, when EB Chain and HW Florey achieved the purification of penicillin for clinical treatment of bacterial infections, about 6,000 antibiotics produced by microorganisms have been discovered, of which more than 100 have practical value. These antibiotics and other microbial fermentation drugs (such as simvastatin, acarbose, sodium hyaluronate, etc.) have saved a large number of lives and played an important role in protecting people's health.
However, it is not an easy task to successfully register biosynthetic and traditional microbial fermentation APIs and obtain marketing authorization. Compared with chemically synthesized APIs, the process development, quality standard establishment, impurity transfer and removal research of fermentation APIs are generally more complicated. If the applicant does not have a good grasp of the relevant professional knowledge, it is likely to be rejected by the regulatory agency due to violating the "red line" in drug registration, resulting in disastrous consequences.
In this live broadcast, we are honored to invite our old friend from Yaozhi Lecture Hall, Mr. Li Yinbo, co-founder of Xizi Pharmaceutical , to share with us the course "Analysis of Registration Key Points of Biosynthesis and Traditional Microbial Fermentation APIs". We will discuss the introduction of biosynthesis and traditional microbial fermentation, basic technical requirements for registration of fermentation APIs, and analysis of typical registration defects, in order to provide useful reference for practitioners.
The show will start on time at 19:30 on the evening of May 9 (Thursday) (Yaozhi Data/Yaozhi Toutiao video account will be broadcast simultaneously). Welcome everyone to scan the QR code in the picture to make an appointment in advance, don’t miss the live broadcast~
>>>Instructor Introduction
Li Yinbo
Co-founder of Xci Pharmaceuticals
With more than ten years of experience in drug R&D, registration and project management, he is proficient in domestic and foreign AEP registration regulations and technical review requirements. He has been invited to share his drug registration experience at the National Medical Products Administration Advanced Training Institute (NMPAIED), the World Pharmaceutical API China Exhibition (CPhI China), Tongxieyi Forum, etc. for more than 30 times. He has extremely rich practical experience in AEP registration and a good industry reputation. He is currently the general manager and chief consultant of Xizi Pharmaceutical, and is committed to providing professional, efficient and honest AEP registration consulting services in China, the United States and Europe to domestic and foreign pharmaceutical customers.