Technical Report No.42 Process Validation of Protein Manufacturing 技术报告42号 蛋白制造工艺验证 PDA Journal of Pharmaceutical Science and Technology 注射用药物协会杂志-制药科学与技术 2005年9/10 增刊 59卷 S-4 蛋白制造工艺验证工作组成员： Chris Bussineau, Ph.D., Chiron Corporation, Co-Chair Robert Seely, Ph.D., Amgen, Inc., Co-Chair Genevieve Lovitt, G.I. Lovitt& Associates, Project Manager/Technical Editor James Fernandez, Fernandez and Associates, PDA Liaison Greg Blank, Ph.D., Genentech, Inc. E.J. Brandreth, Favrille, Inc. Chris Bussineau, Ph.D., Chiron Corporation Doris Conrad, Consultant, GlaxoSmithKline Biologicals Rebecca A. Devine, Ph.D., Independent Regulatory Consultant Robert J. Ferris, Ph.D., Chiron Corporation Koen de Heyder, GlaxoSmithKline Biologicals Robert W. Juffras, M.S., Wyeth BioPharma Peter Levy, Millennium Pharmaceuticals, Inc. Wolfgang List, Ph.D., Aventis Behring Morten Munk, CMC Biopharmaceuticals A/S Brian C. Neely, Don Hill and Associates, Inc. Stephen Notarnicola, Ph.D., Biogen Idec Rhona O’Leary, Ph.D., Genentech, Inc. Harold van Deinse, Baxter Healthcare Corporation Table of Contents目录 1 Introduction 简介 ................................................................................................................................................................. 3 1.1 Purpose 目的 ............................................................................................................................................................... 3 1.2 Scope 范围 .................................................................................................................................................................. 3 2 Definitions 定义 .....................................................................................................................................................
