The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

John Geigert, Ph.D., RAC is President of BioPharmaceutical Quality Solutions, in San Diego, California. He has over 40 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 20 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 3rd Edition (May 2019).

約翰·蓋格特（John Geigert），博士，RAC，是位於加州聖地牙哥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超過40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、製造與管控（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20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》第三版（2019年5月）的作者。