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 | 1:30 PM – 4:30 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

Part 2: 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.

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 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 3-part course is designed for new team members as well as experienced staff in downstream bioprocess development and management groups to enhance their understanding of the science behind the products, explore new production platforms, identify/evaluate new technologies that may be incorporated into existing platforms, or take a step toward creating new platforms for next-generation processes and products. The goal is to provide a context for process design and optimization, and offer a clearer understanding of new methods and some considerations for their adoption.