CMC Regulatory Compliance Strategy for Biopharmaceutical Manufacturing Training Course (PDA 526)

Chemistry, Manufacturing, and Control (CMC) regulatory compliance strategy encompasses those activities that a manufacturer is required/expected to be carried out by a regulatory authority to protect the patient from the manufactured drug product. Such activities involve Genetic Development, Process Development, Analytical Development Manufacturing, Quality Control, Quality Assurance, and Regulatory Affairs. The coordination and timely completion of all the activities by all these CMC groups is necessary for entering clinical development and for continuing to eventually obtain market approval. CMC teams have varying degrees of experience and may not fully appreciate the significant differences and extra challenges in the CMC regulatory compliance strategy for the diverse group of biopharmaceuticals – both those that are protein-based (recombinant proteins, monoclonal antibodies, bispecific antibodies, Fc fusion proteins, Fab fragments, and antibody-drug conjugates (ADCs), as well as biosimilars) and those that are nucleic acid-based (viral and non-viral gene therapy vectors, genetically modified patient cells). Examples of CMC strategies that worked and those that did not work will be discussed.

This training course will provide insights and practical guidance for the CMC teams to develop a cost-effective, risk-based CMC regulatory compliant strategy for the manufacture and control of biopharmaceuticals from first-in-human (FIH) clinical studies through market approval. The training course emphasis will include CMC regulatory guidance (FDA, EMA, and ICH), as well as real-world case examples illustrating CMC regulatory compliance delays in advancing clinical development and blocking market approval.

Upon completion of this event, participants will be able to:

1. Determine the importance and underlying principles involved in establishing a "minimum CMC regulatory compliance continuum" risk-based strategic approach for moving a biopharmaceutical through clinical development into the marketplace
2. Understand the important role the regulatory authorities have in establishing requirements/expectations for patient safety for the diverse group of ever-expanding products under the biopharmaceutical heading, and the need for the biopharmaceutical manufacturer to identify and meet those applicable for their specific product

Please visit PDA Biopharmaceuticals Training Courses for more options and/or related events!