Risk Management Of Osteoblast Development In Biological Company "L"

The 21 st century is an era of regenerative medicine.The rapid development of biomedical technology has made it uniquely attractive for disease prevention and treatment.However,the field of biomedical research and development has properties of a lengthy duration for development,sizable investments,and considerable risks.Therefore,the objective of this study is to provide a reference to project risk managements in biological research institutions that are developing projects pertaining to cell treatment therapies.In any case with the development of new technologies and products,the goal is to save time,minimize costs and help make decisions on whether the project should move forward based on the risks involved in their project.This thesis uses L company's osteoblast research and development proposal as a study case.Osteoblasts are a type of cell that can eventually form bone in the body.The project at hand starts off with a high concentration of myoblast cells and transdifferentiates these cells into osteoblasts by transfecting the cells with bone morphogenetic protein-2 and vascular endothelial growth factor-165 DNA plasmids.The osteoblasts are then combined with bone-like material to form a suitable scaffold to repair bone defects in animal models.To perform this risk analysis,information and data are collected via published literature,domestic and foreign research reports and by interviewing experts in the fields.Quantitative risk analysis methods include an impact and probability risk assessment matrix and a Monte Carlo simulation for the project schedule and financial budget.Quantitative methods consist of risk identification by means of brainstorming and reviewing literature,evaluating the current regulations involved in cell therapy research,and providing suggestions for monitoring possible risks from the risk assessment matrix.Using these methods,a frame was provided for future researchers to follow when evaluating their respective project regarding regenerative medicine.Major issues in this industry were evaluated,such as the cell's retention ability,facing unwanted cell differentiation and the possibility of immune rejection.It was also pointed out that not all cellular therapies are alike and different types of cells pose different types of risks.