Training Workshop Program

Workshops for 2017

The Training Workshop program provides advanced tutorials covering various aspects of preparative chromatography. Dynamic presentations covering both fundamentals and applications are presented by leading academic and industrial scientists and cover both fundamentals and real-world applications. Two Workshops are offered - one emphasizing biomolecules including continuous processing, the second small and intermediate size molecules, including peptides, oligonucleotides, chiral chemicals, and APIs and including SMB and SFC. In addition, new this year are two Morning Tutorials that complement the Workshop program by addressing topics that will help the chromatographer overcome the challenges that are encountered on a daily basis in both analytical and prep applications. The presentations will provide the knowledge you need to implement preparative chromatography to solve today's separation problems as well as to understand tomorrow's technology.

Training to learn about various aspects of process chromatography will be presented on the Sunday preceding the meeting and on Monday and Tuesday mornings. Workshop and Tutorial registration is in addition to the symposium registration fee (only Sunday workshops are free to student registrants if space is available, noting that paid Sunday workshop participants receive priority consideration and the student must pre-register to participate). Certificates of completion recognizing attendance at the Sunday workshops will be awarded. The PREP Symposium reserves the right, without notice, to modify the workshop and tutorial material or schedules, as well as to amend the roster of workshop and tutorial presenters. Workshops and Tutorials are open to conference and non-conference participants.  The cost to attend Workshops and Tutorials is in addition to the symposium registration fee.

 

2017 Training Workshops

 

See below for details about each workshop and tutorial

  • WORKSHOP 1 – Sunday, July 16, 9:00 AM – 1:00 PM (includes morning coffee and mid-morning break)

Fundamentals of Preparative Chromatography for Biomolecule Purification by Batch and Continuous Chromatography

Instructors: Giorgio Carta, Univ. of Virginia; Alois Jungbauer, BOKU, Vienna; Massimo Morbidelli, ETH Zurich

Focus on biomolecule chromatography, stationary phases, binding capacity and selectivity, mass transfer, modeling, design for capture and resolution, multicolumn and continuous chromatography processes.

 

  • WORKSHOP 2 - Sunday, July 16, 2:00 PM – 6:00 PM (includes afternoon break with refreshments)

Fundamentals of Preparative Chromatography for Purification of APIs, Peptides, and Oligonucleotides by Batch Chromatography, SMB, and SFC

Instructors: Olivier Dapremont, Ampac Fine Chemicals; Geoffrey Cox, PIC Solution

Focus on small molecule pharmaceuticals, APIs, chiral molecules, peptides, oligonucleotides, HPLC, column packing, gradient elution, overloaded chromatography, continuous chromatography, SMB, SFC, examples and industrial applications.

 

  • TUTORIAL - Monday, July 17, 7:00 AM – 8:25 AM (includes light breakfast)

Tips, Tricks, and Troubleshooting Analytical and Overloaded Prep Chromatography

Instructors: Cecilia Mazza, AkzoNobel; Tony Yan, Pfizer, Inc.

Focus on analytical chromatography, overloaded chromatography, HPLC, SFC, examples of small molecules, APIs, peptides.

  • TUTORIAL - Tuesday, July 18, 7:00 AM – 8:25 AM (includes light breakfast)

Practical Concepts on Process Characterization and Validation of Biopharmaceuticals based on QbD Principles

Instructor: Gisela Ferreira, MedImmune

Focus on Quality by Design, quality risk management, overall process control strategy, process characterization, application examples.  

 

Workshop and Tutorial Descriptions

Sunday Workshop 1:  9:00am - 1:00pm

Fundamentals of Preparative Chromatography for Biomolecule Purification by Batch and Continuous Chromatography

Focus:  Biomolecule chromatography, stationary phases, binding capacity and selectivity, mass transfer, modeling, design for capture and resolution, multicolumn and continuous chromatography processes.

 

This workshop will focus on the theory and practice of biomolecule chromatography. Since mass transfer and the structure of the stationary phase influence deeply chromatographic performance, the main emphasis is on describing adsorption/desorption kinetics in single and multicomponent systems and determining the relationship between stationary phase properties and process performance. The latest advances in stationary phase developments will be reviewed along with methods for their experimental characterization. Design and optimization strategies for capture and resolution applications will be discussed including multicolumn and continuous bio-chromatography processes.  

 

Topics:  Adsorption equilibrium and transport in single and multicomponent systems; Stationary phases for small and large biomolecules; Design and optimization of batch processes for capture and high-resolution steps; Multicolumn and continuous bio-chromatography processes; Process validation.

 

Instructors:

 

Giorgio Carta received his Ph.D. in Chemical Engineering from the University of Delaware in 1984. Since then he has been a professor in the Department of Chemical Engineering at the University of Virginia, where his research focuses on transport phenomena and bioseparations. He regularly organizes professional courses on various aspects of bioseparations, including a course on protein chromatography development and scale-up together with Alois Jungbauer.  

 

Alois Jungbauer is the head of protein technology and downstream processing at the Department of Biotechnology of the University of Natural Resources and Applied Life Sciences in Vienna (Austria). For more than 20 years, Professor Jungbauer has worked in biochemical engineering, with a focus on bioseparation, where he has published widely and holds 15 patents. For over 10 years, he has organized a biennial professional course in protein chromatography focused on mass transfer, dispersion, and scale-up.

 

Massimo Morbidelli received his Laurea in Chemical Engineering at the Politecnico di Milano in 1977, and his PhD in Chemical Engineering at the University of Notre Dame in 1986. After appointments as professor at the University of Cagliari (Italy) and at the Politecnico di Milano, since 1997 he is Professor of Chemical Reaction Engineering at the Institute for Chemical and Bioengineering at ETH Zurich (Switzerland). His research interests are in polymer reactions and reaction-separation processes based on continuous chromatography and in biomolecule purification with specific focus on therapeutic proteins and monoclonal antibodies. He is co-author of more than 300 papers, 11 international patents and 4 books. He serves as an associate editor of Industrial & Engineering Chemistry Research, and is a member of the scientific board of several international journals. He is the recipient of the 2005 R.H. Wilhelm Award in Chemical Reaction Engineering of the American Institute of Chemical Engineers.  

 

Sunday Workshop 2:  2:00pm - 6:00pm

Fundamentals of Preparative Chromatography for Purification of APIs, Peptides, and Oligonucleotides by Batch Chromatography, SMB, and SFC

 

Focus:  Small molecules, APIs, peptides, oligonucleotides, chiral molecules, HPLC, column packing, gradient elution, overloaded chromatography, SFC, SMB, examples and industrial applications.

 

This workshop will focus on development of methods for the preparative purification of small molecules for the pharmaceutical industry. After an introduction of the theory, optimization and practice of prep HPLC, SMB and SFC for small molecule separations, the instructors will present practical approaches to the development of preparative separation through a series of examples. The attendees will learn valuable information and techniques to apply in the laboratory and at manufacturing scale to increase throughput and performance.

 

Topics:  Prep HPLC batch - Theory, optimization and practice; SMB - Principle and technology; SMB - Examples and applications; SFC - Theory, equipment and examples.

 

Instructors:

 

Olivier Dapremont received is PhD in Chemical Engineering and Applied Chemistry from University of Paris on the development of continuous chromatography for the pharmaceutical industry.  He has worked on the development of SMB technology since 1992. He is currently Executive Director of Process Technologies at AMPAC Fine Chemicals where his role encompasses the development of SMB separations using multiple SMB units ranging from 4.6 mm to 1 m in diameter as well as developing continuous processes for the manufacturing of APIs.  He is coauthor of several publications and patents related to the use of SMB applications for the purification of small molecules. 

Geoffrey Cox received his PhD in Organic Chemistry from the University of Sheffield, England.  Since then his career has been centered around chromatography, starting with preparative gas chromatography through introduction of HPLC to the premier Government analytical laboratory in the UK, development of bonded stationary phases and moving to preparative and industrial scale chromatography first with Du Pont and then in the mid-1980s as Director R&D with Prochrom. In 1997 he moved to Chiral Technologies, first in Europe before relocating to the USA as VP Technology, working in chiral separations. In March 2011 he started the US subsidiary of PIC Solution, the French SFC manufacturer, in order to expand the company’s business into North America. He is author and coauthor of several publications and patents related to the use of chromatography for the purification of small molecules using multiple techniques. 

 

Monday Tutorial:  7:00am - 8:25am 

Tips, Tricks, and Troubleshooting Analytical and Overloaded Prep Chromatography

 

Focus: Analytical chromatography, overloaded chromatography, HPLC, SFC, examples of small molecules, APIs, peptides

 

This workshop will focus on the practical aspects of analytical and preparative chromatography, scale-up, and how to overcome the challenges that the chromatographer encounters on a daily basis by using the tips and tricks provided.

 

Topics:  Analytical and Preparative chromatography purpose, practical scaleup, issues with peak shape, considering the whole chromatographic system (equipment, column and software) as contributors to the final chromatographic result, troubleshooting tools for improved chromatographic performance.

 

Lecturers:

Cecilia Mazza has worked with small molecules, APIs, peptides and proteins for twenty five years, both in analytical as well as preparative chromatography. She is product manager and regional sales manager for Kromasil columns and bulk at AkzoNobel in Sweden. 

Tony Yan is currently working for Pfizer, Inc. (Groton, CT, USA) in the field of impurity isolation for structure elucidation in the department of pharmaceutical science. He has worked in pharmaceutical research and development in the area of chiral and achiral purifications, and impurity isolation for over 20 years. 

Tuesday Tutorial:  7:00am - 8:25am 

Practical Concepts on Process Characterization and Validation of Biopharmaceuticals based on QbD Principles

Focus: This workshop will focus on the practical aspects of analytical and preparative chromatography, scale-up, and how to overcome the challenges that the chromatographer encounters on a daily basis by using the tips and tricks provided.

 

Topics:  This interactive tutorial introduces principles of Quality by Design including preparation of risk assessments, design of experiments for process characterization, statistical data analysis, quality risk management and validation of biopharmaceutical processes.   Topics: Quality by Design, quality risk management, overall process control strategy, process characterization, application examples.

 

Lecturer:

Gisela Ferreira received her Ph.D. in Chemical Engineering from the University of Maryland Baltimore County in 2001 and is currently Principal Scientist in the Process Biochemistry Group at MedImmune. Prior to joining MedImmune she held positions as Senior Scientist at Medarex in the downstream department. Dr. Ferreira has broad biotechnology experience and expertise in areas including process development for large-scale cGMP manufacture of biologics, recombinant biopharmaceutical purification (early and late stage development), Quality by Design, technology transfer and scale-up.

 

 

 

 

 

 

 

 


CONTACT
PREP Symposium/Exhibit Manager
Ms. Janet Cunningham
Barr Enterprises
       www.LinkedIn.com/in/BarrEnterprises       301-668-6001
janet@barrconferences.com