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Introduction to Downstream Process Development



Part 1: Tuesday, January 26, 2021 | 1:00 PM 4:00 PM (US ET)

Part 2: Tuesday, February 2, 2021 | 1:00 PM 4:00 PM (US ET)

Part 3: Tuesday, February 9, 2021 | 1:00 PM 4:00 PM (US ET)


Instructor:

David Wood, PhD, Professor of Chemical and Biomolecular Engineering, The Ohio State University


David Wood is a Professor of Chemical and Biomolecular Engineering at The Ohio State University. He received his undergraduate degree from Caltech in 1990 with a double major in Chemical Engineering and Molecular Biology and has worked at Amgen and Bristol Myers Squibb in areas of upstream and downstream processing. Over the last 20 years, Professor Wood has developed groundbreaking new technologies in downstream bioprocessing, with a focus on self-cleaving affinity tag methods. His work has led to several issued patents in this area, and he is now an active consultant in the area of biosimilars development and intellectual property.

Part 1: Introduction to Downstream Process Development – Basic Strategies

This module is designed to introduce the basic technologies and strategies used to purify recombinant proteins at clinical and manufacturing scales. Included will be an overview of basic harvest, capture and polishing approaches, with a discussion of specific chromatographic and membrane purification methods that are commonly observed in conventional bioprocesses. The ultimate goal is to provide a strong foundation for understanding and evaluating downstream bioprocessing trains.

Topics to be Covered:

  • Key impurities for mammalian and microbial processes
  • Basic harvest methods for mammalian and microbial cell processes
  • Overview of chromatographic methods commonly and not commonly used
  • The basics of membrane separation methods, including materials and configurations
  • An overview of different membrane applications (micro, nano, and ultrafltration)
  • Special considerations for mammalian cells processes – viral clearance
  • Special considerations for E. coli processes – endotoxin removal

This module is to introduce two model downstream process platforms that encompass a large variety of conventional biopharmaceutical products. The first is a typical monoclonal antibody production process, with particular attention paid to the function of each downstream operation and its key function. The second is a microbial process with refolding, where the overall process and its development will be included. Common process variations will be introduced as well.

Topics to be Covered:

  • Key impurities and basic strategies for a typical monoclonal antibody process
  • Harvest, Protein A capture and downstream polishing steps
  • Viral clearance and validation strategies
  • Key impurities and basic strategies for a process based on E. coli expression.
  • Harvest, clarification, refolding and purification steps
  • Commonly observed variations to these platforms

 

Part 2: Case Studies: Known Processes and Downstream Platforms 

This module is to introduce two model downstream process platforms that encompass a large variety of conventional biopharmaceutical products. The first is a typical monoclonal antibody production process, with particular attention paid to the function of each downstream operation and its key function. The second is a microbial process with refolding, where the overall process and its development will be included. Common process variations will be introduced as well.

 

Part 3: Cutting-Edge Processes and Next-Generation Technologies

The biopharmaceutical industry is under continuous pressure to develop new and potentially disruptive technologies for producing their products. Among the more recent developments are approaches in continuous manufacturing, non-chromatographic methods, and intensified processes that minimize costs and simplify process development. This module will provide an introduction to several of these, with some analysis of their potential strengths and weaknesses from a practical standpoint.

Topics to be Covered:

  • Single-use and continuous operations
  • Flocculation, precipitation and other alternatives to chromatography
  • Alternate chromatographic formats
  • Intensified membrane and separation processes
  • Single-use technologies and their optimal applications
  • Issues associated with new technology adoption
  • An examination of successful and failed technologies of the last 20 years

Who Should Attend:

This course is designed for those who are interested in identifying and evaluating new technologies that might be incorporated into existing platforms, or potentially applied to the creation of new platforms for next-generation processes and products. The ideal outcome is a clearer understanding of these new methods and some considerations for their adoption.