The Tech Department of Hansyn Pharma features 3 sub-units: Shanghai R&D, Zhangjiagang Tech Center and Zhangjiagang Engineering Center. From a product development prospective, Responsibilities of Tech Department covers project evaluation/introduction, process development, quality research, analytical method development, scale-up study, process optimization and support of existing production, etc. Tech Department is also responsible for intellectual property research and maintenance, government fund and project application and implementation, collaboration with national and international research institutions and industrial partners. Implementing the concept of QbD, the Tech Department has built up quality and document systems that fulfill the requirement of authority inspection.
With total investment over 20 million RMB, the Tech Department of Hansyn Pharma features several process, analytical and kilo-scale laboratories and a pilot line. All labs are fitted with penal-controlled fume hoods, high density ceramic surfaced benches and are equipped with thermo- and cryostat controlled jacketed reactors (300 mL -20L), thermo- and cryostat controlled jacketed high pressure reactors (1L, 3L), HPLCs, GC-FID, LC-MS, automatic KF titrators, automatic potentiometric titrators, stability chambers (photo, humidity, thermal). The R&D pilot line features 4 x 250 L reactors (Hatselloy x 1, GL x 2 , GL x 1) with associated centrifuge and dryer enabling the Tech Department to receive pilot scale registration and commercial production tasks.
