The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
暫譯: 生物製藥CMC法規遵循的挑戰

John Geigert, Ph.D., RAC is President of BioPharmaceutical Quality Solutions, in Carlsbad, California. He has 50 years of experience within the biopharmaceutical industry developing Chemistry, Manufacturing & Controls (CMC) regulatory compliant strategies for recombinant proteins, monoclonal antibodies, biosimilars, gene therapy vectors, and cell‐based medicines. Dr. Geigert has 10 years Executive Management experience as Vice President, Quality & Executive Officer at IDEC Pharmaceuticals, and Vice President, Quality at Immunex. He now has served for 25 years as an international independent CMC regulatory compliance consultant. He is a past chair of the PDA Biopharmaceutical Advisory Board. Dr. Geigert is also the author of the book, The Challenge of CMC Regulatory Compliance for Biopharmaceuticals 4th Edition (June 2023).

約翰·蓋格特（John Geigert），博士，RAC，是位於加州卡爾斯巴德的生物製藥品質解決方案公司的總裁。他在生物製藥行業擁有50年的經驗，專注於為重組蛋白、單克隆抗體、生物相似藥、基因治療載體和細胞基藥物開發符合化學、製造和管控（Chemistry, Manufacturing & Controls, CMC）法規的策略。蓋格特博士在IDEC製藥公司擔任品質副總裁及執行官，並在Immunex擔任品質副總裁，擁有10年的高層管理經驗。如今，他已擔任國際獨立CMC法規合規顧問25年。他曾擔任PDA生物製藥諮詢委員會的主席。蓋格特博士也是《生物製藥CMC法規合規挑戰》第四版（2023年6月）的作者。