Separation Technologies for Bioprocessing

Separation technologies for downstream bioprocessing are the focus for this course. Basic principles of tangential flow filtration, chromatography, centrifugation and freeze drying are reviewed and then expanded to cover design, materials and operation. Cleaning of these types of systems is reviewed in one lecture. Attention is given to understanding how to evaluate and control the consistency of the systems operations. Problem solving workshops allow the participants to apply the principles, strategies and technologies discussed to design a protein purification process. Case studies and panel discussions review specific examples of common problems and their successful resolutions.

Course Director

Warren MacKellar, Sr. Research Advisor, Eli Lilly and Company

• BS in microbiology, PhD in biochemistry, and post doctoral position at Indiana University
• A member of the team that did the research, development and scale up of the process to produce the natural sequence human growth hormone by recombinant technology and process development experience on a number of other recombinant proteins. He has served as manager of the fermentation development group, head of biotechnology research, group leader in biotechnology research, and senior research scientist in the oncology research division.

Bioprocessing Overview Icon
A (B) next to a course description indicates that it is part of the “Bioprocessing Overview.”

Monday, May 21

08.00 - 08.30
Introduction and Overview

08.30 - 10.00
Introduction to Tangential Flow Filtration (B)
William Eykamp, Independent Consultant

10.30 -12.00
Filtration System Design (B)
Herb Lutz, Consulting Engineer,
Millipore Corporation

13.00 - 16.30
A Case Study on Design, Optimization, Engineering Constraints and Scale-up of TFF
Elizabeth Goodrich, Systems Process Engineering Manager, Millipore Corporation

Tuesday, May 22

08.30 - 10.00
Physical and Chemical Properties of Proteins (B)
Warren MacKellar, Sr., Research Advisor, Eli Lilly and Company

10.30 - 12.00
Chromatography – General Principles and Engineering Fundamentals (B)
Alan Hunter, Pfizer, Inc.

13.00 - 14.00
Chromatography Media (B)
Jon Webb, Principal Research Scientist,
Eli Lilly and Company

14.00 - 14.30
Purification Mini-Workshop - Chromatography Part I
Warren MacKellar, Sr. Research Advisor,
Eli Lilly and Company

15.00 - 16.30
Biomolecule Purification Process Design (B)
Joseph P. Morris, President, J.P. Morris Consulting LLC

16.30 - 17.00
Purification Mini Workshop - Chromatography Part II
Joseph P. Morris, President, J.P. Morris Consulting LLC

Wednesday, May 23

08.30 - 10.00
Column Design for Chromatography Systems (B)
Rob Hershberg, Scientific Director, Amgen

10.30 – 12.00
Process Control Strategies (B)
Graham Tulloch, Principal Research Scientist, Eli Lilly and Company

13.00 – 17.00
Protein Purification Design Workshop

Thursday, May 24

08.30 - 10.00
Chromatography Process Validation (B)
Gail Sofer, Director of Regulatory Services, GE Healthcare

10.00 - 12.00
CIP for Biomolecule Separations Systems (B)
Sam Lebowitz, Technical Sales Manager, Electrol Specialties Company

13.00 - 14.30
Biomolecule Isolation (B)
John McKenna, Senior Technical Consultant, Westfalia Separator Company

15.00 - 16.30
Freeze Drying Techniques (B)
Jim Searles, Associate Director, Aktiv-Dry, LLC