报告题目：Process Scale Up of Pharmaceutical Dosage Form Manufacturing(药品制剂制造的工艺放大)

报告时间：2018年6月4日（周一）14:30-16:30

报告地点：南校区第四教学楼106

报 告 人：Luk LI 教授

主办单位：药学院

          研究生院（学科建设办公室）

          辽宁省药学研究生创新与交流中心

报告人简介：

Dr. Luk Chiu Li is currently an independent pharmaceutical consultant after retiring from Abbott. Dr. Li earned a Bachelor Pharmacy degree in Taiwan, a Master degree in Pharmaceutical Technology from U of London, and a Ph.D. degree in Industrial and Physical Pharmacy from Purdue University. During his 25 years of service at Abbott, Dr. Li held different positions and moved up the leadership ladder in both management and science; including Group Leader and Manager in Parenteral Product Development, Director of Drug Delivery, and Director of New Product Development. Dr. Li has extensive industrial experience in pharmaceutical dosage form design and manufacturing process development. Prior to joining Abbott, Dr. Li was the Assistant Professor of the College of Pharmacy of University of Oklahoma. Dr. Li has been the visiting professor for Shenyang Pharmaceutical University for more than ten years and he is also delivering lectures for the Department of Pharmacy and Pharmacology of Hong Kong University. Dr. Li has published more than 50 peer reviewed scientific paper, four book chapters, and seven patents.

报告内容简介：

During the development of a pharmaceutical product, scale-up occurs in several stages: from laboratory scale to pilot scale to the final commercial production scale. Failures in production scale-up can result in products failing established specifications with the consequence of product launch delay and financial loss of the company. Scale-up involves the increasing the total numbers of dosage unit produced by utilizing industrial equipment with increased manufacturing capability in terms of physical dimension and speed. The success of scale-up relies on the transfer of technology and knowledge that have accumulated during the small-scale development of the product and process. Therefore, a robust formulation and a well- characterized process are important. Scale-up is also an integral part of the Product Life Cycle Validation Approach adapted by the US-FDA. The Critical Quality Attributes (CQAs), Critical Material Attributes (CMAs), and Critical Process Parameters (CPPs) that are determined during the Process Design Phase as required by the Quality by Design (QbD) approach are the key factors to be considered during the scale-up phase of the process. In this presentation, the general engineering scale-up principles and issues as well as their resolution during scale-up of a tablet manufacturing process will be discussed.