APAC’s facilities and quality systems are designed for production of active pharmaceutical ingredient (API) for use in pre-clinical studies through phase III human clinical trials. With its state-of-the art facilities in Shanghai region of China, APAC chemistry manufacture operates three sites from lab scale to pilot production and commercial manufacture to provide the capacities to manufacture small molecule, sugar compound, solution synthetic peptides, and cytotoxic APIs. These facilities are operated under cGMP environment and at the same time are modulated in nature to allow for maximum flexibility.
Suzhou APAC PharmaTech Process Research capability
The mission of Suzhou APAC PharmaTech’s process chemistry team is to find and optimize the ideal synthetic route of the chemical entity, taking into account factors such as safety, environmental considerations, yield and cost-effectiveness, as well as critical process parameters such as color, concentration, temperature, pH, and pressure reaction time.
Our team will establish in-process control parameters/product specification along with analytical methods,sampling method/record, stability and storage conditions, special safety concerns or precautions, special observations such as color, smell, heat, etc.
Therefore APAC team will be able to handle projects required impurity removal to <0.10%, sensitive moisture/temperature conditions and USP/EP monographic product spec conformance.