Institute for International Research

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.

Instructor

Antonio R. Moreira, Ph.D., Professor, Chemical and Biochemical Engineering, Vice Provost, University of Maryland, Baltimore County

Course 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