Research & Development
Juzen Chemical Corporation, so as to contribute to shortening the development period for new drugs and establishing efficient manufacture of active pharmaceutical ingredient (API), has skilled and experienced researchers engaged in the research and development of safe, robust and highly productive process on the basis of process chemistry and process engineering knowledge which have been nurtured for a long period. The research staffs with full expertise of GMP and manufacturing facility implement experiments, assuming commercial scale of manufacture even from the stage of lab examination, when any issues considered generating at the time of scale-up are clearly identified beforehand, which strongly supports the secure and prompt supply of APIs for clinical trial and the smooth transfer to commercial manufacture.
Main facilities in R&D center
The following organic synthesis technologies are our platform technologies which we have cultivated and accumulated for 50 years. Above all, we are confident of scale-up examination program and know-how for industrialization and have special strength in the examination of industrialization of the primary process disclosed by customers.
- Ultra-low temperature reaction (-70 )
- Grignard reaction
- Suzuki-Miyaura reaction
- Buchwald-Hartwing reaction
- Sonogashira-Hagihara reaction
- Mizoroki-Heck reaction
- Reduction reaction
- Diels-Alder reaction
General Lab is available for the process development from a few to hundred grams scale and overall scale-up examinations. The experimental area segregated from the office with glass provides Draft chambers etc completely furnished with automatic fire- extinguishing device for the experiment through the night, and thus, health and safety are meticulously cared of. Further, process tracing analysis with HPLC is performed simultaneously in line with the reaction, where efficient experimental examination is realized to be available.
Anti-Hazard & Clean Lab
This lab is suited for the research of high potency API, equipped with containment function and providing cleanliness degree equivalent to 100,000. Chemical hazard chamber (CHC) and Balance enclosure (BE) are installed inside, confirmed to provide NMT 1µg/m ³of OEL of the containment performance (measured against SMEPAC criteria)
Safety Research Lab
For the purpose of prior safety evaluation and secure implementation of optimization examination of process, extraction of latent safety issues in components and process along with the estimation of problematic points generating in the scale-up is implemented using DSC and Reaction calorimeter, through which we pursue to attain the establishment of safe and stubborn process from the earlier stage.
Walk-in Draft Lab
Walk-in Draft Lab is available for catalytic hydrogenation reaction experiment with autoclave and for 10 L scale of kilo-lab experiment. From the aspect of safety care, hydrogen detector is also installed.
Analytical Development Lab
Analytical Development Lab houses analytical equipment including LC-MS, GC, KF etc, enabling the assignment /identification of impurities and crystal polymorphism investigation together with NMR, XRD, FT-IR etc in adjacent Analytical Research Center, and facilitating the speed-up of process development.