As a national high-tech enterprise focusing on the R&D and production of steroidal drug raw materials, Xianju Junye Pharmaceutical has built six core technology platforms, forming a complete technology chain from front-end R&D to industrial application.
It provides solid technical support for building the world's leading steroid drug R&D and manufacturing base.
Gene editing technology (such as CRISPR) and enzyme directed evolution are used to reprogram microbial cell factories and transform key enzymes to construct efficient strains for the biosynthesis of steroid cores (such as AD, ADD, 4-AD, etc.) and key intermediates.
The platform aims to innovate traditional high-pollution, high-energy-consuming chemical synthesis processes, mainly including:
· Electrochemical synthesis technology: Use electric energy as a driving force to replace toxic and expensive chemical redox reagents, achieve efficient and clean functionalization of specific positions of steroids (such as C1, 2 positions), and reduce "three wastes" emissions from the source.
· Continuous flow chemistry technology: Convert traditional batch-type tank reactions into continuous micro-channel reactions. For common highly exothermic and high-risk reactions in steroid synthesis (such as nitration and hydrogenation), precise temperature and reaction time control can be achieved, greatly improving process safety and reproducibility, and making it easy to scale up.
· Development and application of high-performance catalysts: Develop new high-selectivity, high-activity chemical and biological catalysts, and support catalyst recycling technology to improve atom economy and reduce the loss and cost of precious metal catalysts.
· AI design of reaction routes: Using machine learning algorithms and based on massive chemical data, intelligently recommend optimal retrosynthetic routes and green process routes.
· Intelligent optimization of reaction conditions: Automatically design experiments (ADO) through AI algorithms (such as Bayesian optimization) to quickly lock the best reaction parameters (such as temperature, pH, substrate concentration), greatly reducing the number of experimental trials and errors, and shortening the research and development cycle.
· Crystal Form Prediction and Design (CSP): Use computational chemistry and AI to predict the polymorphism of steroid drugs, and guide experiments to screen out optimal crystal forms with good physical and chemical properties and bioavailability.
· Focus on efficiency, quality and cost control in the industrialization stage:
· Process Analytical Technology (PAT): Integrate online monitoring instruments (such as FTIR, Raman, FBRM) to conduct real-time monitoring of key processes such as crystallization, fermentation, synthesis, etc., to achieve precise control of product quality attributes (such as crystal form, particle size distribution, purity).
· Intelligent fermentation and separation and purification platform: Use big data models and AI to optimize the feeding strategy and physiological parameters of the fermentation process to improve strain yield. At the same time, advanced technologies such as new chromatographic separation and membrane separation are applied to improve extraction efficiency and product purity.
Continuous manufacturing: Transforming the entire production process from intermittent operations to end-to-end continuous production.
Establish a CNAS-certified process safety laboratory equipped with reaction calorimeter (RC1e) and other equipment to accurately assess the thermal risks of reactions, provide key data support for reactor design and formulation of safety production procedures, and ensure smooth and safe amplification of especially high-risk processes.