Geigert, J., 2023, The Challenge of CMC Regulatory Compliance for Biopharmaceuticals, 4th Edition, Springer Press, New York  Geigert, J., 2019, The Challenge of CMC Regulatory Compliance for Biopharmaceuticals, 3rd Edition, Springer Press, New York Geigert, J., 2017, Applying Phase‐Appropriate GMPs in Personalized Medicines: Development and Manufacturing, presentation at PDA Europe ATMP Conference, June 2019 Geigert, J., 2017, Future For QbD in Biopharmaceuticals, PDA Letter May 2017 Geigert, J., 2016, Biosimilars Are Not Bio‐Generics, presentation at PDA Biosimilars Conference, June 2016 PDA InfoGraphic - Evaluating Biosimilars vs Biologics  (PDA Letter, October 2015)   Geigert, J., 2013, The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics, 2nd Edition, Springer Press, New York  Demystifying CMC Regulatory Strategy for Biologics; Part 1: Complexity of Biologic CMC Regulation; Part 2: Biologics are Not Chemical Drugs; Part 3: An Effective CMC Regulatory Compliance Strategy is Possible; Part 4: Challenges of Adventitious Agent Control; Regulatory Focus, September 2011 - March 2012 What Senior Management Needs to Know About CMC Regulatory Compliance for Biotech Products; Part 1: Initiating Phase 1 Clinical Trials; Part 2: Transition From Phase 2 to Phase 3; Part 3: Submission of the Marketing Application; Part 4: At the Commercial Stage; Regulatory Focus, August-November 2009  Geigert, J., 2004, The Challenge of CMC Regulatory Compliance for Biopharmaceuticals, 1st Edition, Springer Press, New York