报告题目：Process ScaleUp 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 independentpharmaceutical consultant after retiring from Abbott.   Dr. Li earned a Bachelor Pharmacy degree inTaiwan, a Master degree in Pharmaceutical Technology from U of London, and aPh.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 managementand science; including Group Leader and Manager in Parenteral ProductDevelopment, Director of Drug Delivery, and Director of New ProductDevelopment.  Dr. Li has extensiveindustrial experience in pharmaceutical dosage form design and manufacturingprocess development.  Prior to joining Abbott,Dr. Li was the Assistant Professor of the College of Pharmacy of University ofOklahoma.  Dr. Li has been the visitingprofessor for Shenyang Pharmaceutical University for more than ten years and heis also delivering lectures for the Department of Pharmacy and Pharmacology ofHong Kong University.  Dr. Li haspublished more than 50 peer reviewed scientific paper, four book chapters, andseven patents.

报告内容简介：

During the development of a pharmaceuticalproduct, scale-up occurs in several stages: from laboratory scale to pilotscale to the final commercial production scale. Failures in production scale-up can result in products failingestablished specifications with the consequence of product launch delay andfinancial loss of the company.  Scale-upinvolves the increasing the total numbers of dosage unit produced by utilizingindustrial equipment with increased manufacturing capability in terms of physicaldimension and speed.  The success ofscale-up relies on the transfer of technology and knowledge that haveaccumulated during the small-scale development of the product and process.  Therefore, a robust formulation and a well-characterized process are important.  Scale-upis also an integral part of the Product Life Cycle Validation Approach adaptedby the US-FDA.  The Critical QualityAttributes (CQAs), Critical Material Attributes (CMAs), and Critical ProcessParameters (CPPs) that are determined during the Process Design Phase asrequired by the Quality by Design (QbD) approach are the key factors to beconsidered during the scale-up phase of the process.  In this presentation, the general engineeringscale-up principles and issues as well as their resolution during scale-up of atablet manufacturing process will be discussed.