IBC Life Sciences

Description

This course provides a comprehensive discussion of the principles and procedures involved in developing cell culture and fermentation processes for the pilot and large scale manufacturing of biopharmaceutical products. The course begins with a discussion of the fundamental concepts in molecular biology, protein expression systems, host cell engineering, selection of high producing clones, and cell culture and fermentation technology. The course moves on to a detailed discussion of how to develop manufacturing processes. The final segment focuses on the current trends in bioprocessing, including a discussion of how implementation of PAT can impact cell culture and fermentation processes and how the concepts introduced in ICH Q8, Q9 and Q10 can be applied. The trend towards use of disposable systems will also be discussed. The course makes use of interactive group discussions, literature-based case studies, and extensive technical references to engage participants with the goal of returning home with new knowledge than can be immediately put to practice in their bioproduction systems.

Agenda

• Overview of the Major Biopharmaceutical Products
• Importance of Cell Culture and Fermentation in Manufacture of Biological Products
• Molecular Biology for the Production of Biopharmaceuticals
• Advantages and Disadvantages of Various Host Cell Types
• Host Cell Engineering and Selection of High Producers
• Cell Culture Media
• Medium Optimization
• Basic Theory of Fermentation and Cell Culture
• Characteristics of Protein Products, Cellular Metabolism and Cell Physiology
• Product Quality Attributes and Process Design
• Bioreactor Development, Selection and Design
• Modes of Bioreactor Operation
• Scale-up and Scale-down Approaches and Methodologies
• Process Characterization Studies; Process Optimization Strategies
• The Concept of Design Space
• Process Robustness and Redundancy
• PAT Applications in Bioprocessing
• Integration of Upstream with Downstream Processing; Process Changes
• Considerations for GMP Manufacture
• Role of Disposable Technologies in Bioprocessing

Who Should Attend?

• Process Development/Sciences (Technicians, Scientists, Engineers, Managers, Directors)
• Manufacturing (Technicians, Supervisors, Engineers, Managers, Directors)
• Research/Discovery (Scientists, Technicians, Managers, Directors)
• Technical Operations (Engineers, Managers)
• Technology Transfer (Scientists, Engineers, Managers)

Instructor

Antonio R. Moreira, Ph.D., Professor, Chemical and Biochemical Engineering, Vice Provost, University of Maryland, Baltimore County
Dr. Antonio R. Moreira is a well-known and highly regarded expert in cell culture and fermentation bioprocessing. Dr. Moreira is Professor of Chemical and Biochemical Engineering at the University of Maryland, Baltimore County (UMBC) where he holds the position of Vice Provost. During his 19 years at UMBC, Dr. Moreira has also been Chair of the Department of Chemical and Biochemical Engineering and Associate Dean of Engineering. Prior to joining UMBC, Dr. Moreira spent ten years in the private sector, holding senior technical management positions with International Flavors and Fragrances, Inc. and Schering Plough Corp. He consults for a number of biotechnology companies in process development, regulatory and GMP compliance, and validation of facilities and processes. Dr. Moreira has an active research program and has authored or co-authored over 150 technical publications, including refereed articles in leading scientific journals and invited and contributed talks at many international bioprocessing conferences.