Jong Ho Lee Email & Phone Number

Let me introduce myself as a process developer who combines technology transfer experience and APIs manufacturing experience. In October 2015, I joined GC corporation as an employee of the purification process team and has been working on developing drug candidates so far. Work experience My three main careers in the process team are participation in 1) the APIs manufacturing process, 2) Feasibility evaluation and 3) Draw up a purification development reports. First, after culturing, purification technology and analysis necessary for API production were performed. Primarily, I performed UF/DF and chromatographic processes and developed processes using screening and purification condition study (DoE-based) methods. Test methods were selected and applied in collaboration with the analytical team to analyze the in-process materials. Additionally, I have experience applying various methods to cell collect/remove and disrupt/ lysis from a process development perspective. Based on the information obtained at this time, we propose a method suitable for the target material and use it for process development. Feasibility evaluation is a task of evaluating the possibility of developing candidate drug substances, and I prepared the basis for evaluating the possibility of task development by organizing items that require the effect of drug substances, yield, purity, cost, and future device investment. The main achievements were to apply for process patents to contribute to the improvement of the research institute’s technology and shorten the process development period by working on feasibility. Finally, I worked on APIs purification process writing docutment for CMC and technical transfer. The main tasks are UF/DF, chromatography, SOP for in-process materials analysis. Additionally, I worked on supplementing the data required for permission. Vision and Career goals I would like to improve the limitations of the APIs manufacturing process and establish an new paradigm manufacturing platform. To achieve the goal, I would like to lead the development of the vaccine production process and technology transfer based on my experience in technology transfer and feasibility evaluation, and to perform the task necessary for approval based on an understanding of the regulations of drug approval organization.