PDA EU00191 CMC Regulatory Compliance Strategy for Recombinant Proteins, Monoclonal Antibodies and Biosimilars

Chemistry, Manufacturing & Control (CMC) regulatory compliance strategy encompasses all of those activities that are required/expected to be carried out by a regulatory authority to protect the patient from the manufactured drug product. Such activities involve Genetic Development (gene development → cell substrate), Process Development (design of the cell culture and purification manufacturing process), Analytical Development (design of the release/stability test methods), Manufacturing (cell banking, carrying out the upstream and downstream, and drug product processes), Quality Control (testing to meet specifications), Quality Assurance (cGMP compliance) and Regulatory Affairs (communication with the authorities). 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.

While many CMC teams are familiar with the CMC regulatory compliance strategy for chemical drug products, they may not appreciate the significant differences and extra challenges in the CMC regulatory compliance strategy for the large size and complex protein-based biopharmaceuticals, which today now include recombinant proteins, monoclonal antibodies (mAbs, bispecific antibodies, Fc fusion proteins, Fab fragments, and antibody-drug conjugates (ADCs)) and biosimilars. Examples of CMC strategies that worked and those that did not work will be discussed.

This 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 these protein-based biopharmaceuticals from first-in-human (FIH) clinical studies through market approval. The 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.

Who Should Attend

This two-day CMC regulatory compliance strategy course is designed for senior management, directors, managers, supervisors, project managers, and personnel in Process/Analytical Development, Manufacturing, Quality, and Regulatory Affairs departments.

Learning Objectives

Upon completion of this course, attendees will be able to:

• Understand the importance and underlying principles of an effective CMC regulatory strategy for biopharmaceuticals to move their products through clinical development into the marketplace
• Learn how to avoid major CMC delays in clinical development or market approval due to an ineffective CMC regulatory compliance strategy