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Introduction of Continuous Flow Chemistry Technology Platform of PharmaResources

2022-05-19 16:15:05

Continuous flow chemistry technology is a subversion of traditional chemical technology in the 21st century, the safety of its technical essence can not only guard the safety from the source of the process, but also use its micro-scale unique mass transfer and heat transfer attributes to easily achieve process strengthening and the safe scale-up of various high-risk chemical processes. Continuous flow chemistry technology will open a new era of high-efficiency and refinement for the pharmaceutical chemical industry, provide effective technical means for the transformation and upgrading of the pharmaceutical industry, enhance innovation capabilities, and achieve "zero emission, green and sustainable development". Over the past decade, the U.S. Food and Drug Administration (FDA) has also been vigorously promoting the application of continuous manufacturing in the production of pharmaceuticals. To this end, the world's major pharmaceutical companies have embarked on the road of continuous manufacturing.

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PharmaResources has been continuously investing resources to establish and develop R&D and production capabilities of continuous flow chemistry technology, aiming to improve the safety and efficiency of the pharmaceutical manufacturing process and provide more options for designing API synthesis routes. In 2021, PharmaResources set up a professional flow technology platform and built a new flow chemistry laboratory with high standards, and actively communicate with the top domestic micro-chemical team Tsinghua University Luo Guangsheng research group and so on.

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Until now, PharmaResources‘ flow technology platform has 12 peristaltic pumps, 5 plunger pumps, several microchannel reactors and several high and low temperature equipment to support the development of flow chemistry for high-risk process in Shanghai site. In 2021, about 15 conventional batch reactions were evaluated, and the safety production of 5kg in 3 high-risk chemical processes was successfully achieved using flow chemistry technology. A PFR production line has been assembled in the company's subsidiary, PharmaResources Kaiyuan, and a CSTR production line is under construction. PharmaResources‘ Flow Technology Platform has the following high-risk process R&D and production capabilities, including but not limited to:

High temperature and high pressure reaction (100 °C ~ 350 °C, 0 ~ 5Mpa)

Cryogenic reactions (-150°C~0°C)

Metal reagent reactions (DIBAL-H, butyl lithium, Grignard reagent, trimethylaluminum, etc.)

Azide reaction

Continuous Micro packed bed hydrogenation reaction

Diazo reaction

Nitrification reaction

Sulfonation reaction

Peroxides involved in oxidation reactions

Ozone oxidation reaction

Swern oxidation reaction

Photochemical reactions

Other reactions involve gases (e.g., carbon monoxide, chlorine, ammonia and so on) 

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At present, the flow chemistry team of PharmaResources can undertake kilogram production of chemicals involving the above high-risk processes, and gradually establish modular continuous flow production lines in Kaiyuan site to achieve safe commercial production of 100 kilograms of various high-risk processes.


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