Preclinical to commercial production solutions
No matter your need at any stage of your project – from preclinical kg scale production of toxicological batches, up-scaled clinical manufacture, or commercial manufacture on tonne-scale – our powerful production capacity and flexibility provides effect quality solutions. In addition,, our experienced technical team can achieve seamless connection ranging from laboratory scale, pilot scale up to commercial production, and ensure that your production process can be quickly transferred.
State-of-the-art manufacture and large capacity
Built to the highest industry standards, our 5 manufacturing sites are located in Tianjin, Fuxin of Liaoning and Dunhua of Jilin (China), and have received Good Manufacturing Practice inspections from many world-wide recognized organizations, including the US FDA , NMPA of China, TGA of Australia and MFDS of Korea.
We have the ability to have a total reaction volume of more than 2455m³, of which 1593m³ is located in the cGMP workshop. Our reactors ranging in size from 5L to 20,000L, will meet the need of any production stage and are able to handle various intricate chemical reactions.
Our large-scale production bases are 120,000 square meters and 140,000 square meters of basic raw materials and registered starting raw materials in Fuxin, Liaoning and Dunhua, Jilin, (all of China). We have taken into consideration the impact of upstream raw material costs on safety and environmental protection issues and have mitigated potential risks.
Asymchem has maintained continuous investments and efforts to apply the most challenging technologies to GMP-compliant production. We are acutely aware of the challenges and risks that laboratory-scale reactions can experience as the project scales up and our experienced production team leverages their years of industry experience to help customers resolve these challenges.
At present, our production workshop can handle a series of challenging reactions including:
● cryogenic reaction (low as 110 ° C),
● high temperature reactions (> 200 ° C),
● high pressure reactions (> 100 atm),
● diazomethane reaction
● non-noble metal catalysis.
In addition, we are one of the few CDMO companies in the world that truly applies green chemical pharmaceutical technology to commercial production. We have utilized flow reaction to many of the world's top ten pharmaceutical companies’ products in commercialization.
We are equipped with independent and powerful analysis departments in seven small molecule drug substance factories across the country, which can effectively support non-GMP / cGMP production process inspection and final product release.