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PD 482: Bioprocess Purification Process Development

Description
This seminar is designed to give the participant a basic understanding of key issues in designing and implementing a purification process for the production of a biopharmaceutical material. Scale-up of chromatographic and filtration operations will be discussed in detail with attention validation issues. Process scenarios for recombinant proteins and antibodies will be used to further the basic concepts.


What You Will Learn


  • Understand and apply basic scale parameters in chromatography and filtration
  • Understand the basics of validation and how they impact process design
  • Process requirements and analytical techniques used to judge quality in manufacturing

Who Should Attend
This seminar is intended for professionals involved in the design, scale-up and operation of bioprocesssystems. Materials presented in this course will be of benefit to process, project and manufacturing engineers and scientists entering the field or requiring further background in specific separation technologies.

 

Instructor/Speaker Panel

  • Rolf Hjorth, Staff Research Engineer, GE Healthcare Bio-Sciences
  • Dr. Kjell Eriksson, Senior Scientist, R&D, GE Healthcare Life Sciences
  • Phil Nelson, Principal Engineer, Process Development, AMGEN
  • Craig Robinson, Technical Director, GE Healthcare Life Sciences

 

SCHEDULE

Monday, 23 June 2008
7:30 am - 5:00 pm Registration Desk Open
7:30 am - 8:00 am Coffee & Pastries
8:00 am - 10:00 am Basic Concepts in Chromatography
A discussion of chromatographic techniques, nomenclature, & metrics used in process development.
Rolf Hjorth
Staff Research Engineer
GE Healthcare Bio-Sciences
10:00 - 10:30 am Refreshment Break
10:30 am - Noon Critical Aspects of Chromatographic Process Design
A discussion of how to design a scalable & robust multi-step purification strategy.
 
Rolf Hjorth
Staff Research Engineer
GE Healthcare Bio-Sciences
12 Noon - 1:00 pm Lunch
1:00 pm - 3:00 pm Process Design I: Membrane Process
A review of the critical aspects of membrane system process design & integration with chromatography processes.
Craig Robinson
Technical Director, North Am & Europe
GE Healthcare Life Sciences
3:00 pm - 3:30 pm Refreshment Break
3:30 - 5:30 pm Process Design I: Membrane Process - cont'd.
A review of the critical aspects of membrane system process design & integration with chromatography processes.
Craig Robinson
Technical Director, North Am & Europe
GE Healthcare Life Sciences

Tuesday, 24 June 2008
7:30 am - 8:00 am Coffee & Pastries
8:00 am - 10:00 am

Process Design II
Optimizing and maintaining the process.

Kjell Eriksson
Senior Scientist, R&D
GE Healthcare Life Sciences

10:00 - 10:30 am Refreshment Break in Exhibits Hall
10:30 am - Noon Process Design II - cont'd.
Optimizing and maintaining the process.
Kjell Eriksson
Senior Scientist, R&D
GE Healthcare Life Sciences
12 Noon - 1:00 pm Lunch w/ Exhibitors
1:00 pm - 3:00 pm

Production Scenario: Antibody Production Process
Elements of a monoclonal antibody purification process

Phil Nelson
Principal Engineer, Process Development
Amgen
3:00 - 3:30 pm Refreshment Break in Exhibits Hall
3:30 - 5:00 pm

Production Scenario: Antibody Production Process - cont'd.
Elements of a monoclonal antibody purification process

Phil Nelson
Principal Engineer, Process Development
Amgen

5:15 - 6:00 pm Keynote: "Trends in Biological Manufacturing - How will our industry change in the next 10 years?"
- Nigel Darby, General Manager BioTechnologies, GE Healthcare Life Sciences
6:00 - 7:30 pm Networking Reception in Exhibits Hall

Wednesday, 25 June 2008
8:00 am - 9:00 am Workshop: Learn about the BPE (BioProcessing Equipment) International Standard
9:30 am - BPE Subcommittee Meetings: Open to the Public
3:30 pm - 5:30 pm Plant Tours: GE Healthcare Uppsala / Alfa Laval Tumba (Seats are limited. Advance sign-up required.)



REGISTER NOW! Visit www.asmeconferences.org/BioprocessEurope08



ASME Travel Policy : ASME is not responsible for the purchase of non-refundable airline tickets or the cancellation/change fees associated with canceling a flight. Please call to confirm that the course is running before purchasing airline tickets. ASME retains the right to cancel a course up until 3 weeks of the scheduled presentation date.





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