Bioprocess Technology Seminars

PD482: Bioprocess Purification Process Development

This course is now available on CD-ROM. To purchase, please call 800-843-2763.

Description

This course 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 course 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.

Schedule

Sunday, October 22, 2006
5:00 pm - 8:30 pm	Registration Open - Avoid the lines on Monday!
Monday, October 23, 2006
7:30 am - 8:30 am	Registration Desk Open / Continental Breakfast
4:30 pm - 5:30 pm	KEYNOTE Presentation
5:30 pm - 7:00 pm	Opening Reception w/ Exhibitors
Tuesday, October 24, 2006
7:30 am - 8:30 am	Registration Desk Open / Continental Breakfast w/ Exhibitors
8:30 am - 10:00 am	Basic Concepts in Chromatography A discussion of chromatographic techniques, nomenclature, & metrics used in process development.	Alan Williams Applications Manager GE Healthcare
10:00 am - 10:30 am	Refreshment Break w/ Exhibitors
10:30 am - 12:00 noon	Critical Aspects of Chromatographic Process Design A discussion of how to design a scalable & robust multi-step purification strategy.	Alan Williams Applications Manager GE Healthcare
12:00 noon - 1:00 pm	Lunch w/ Exhibitors
1:00 pm - 2:30 pm	Process Design I: Membrane Process A review of the critical aspects of membrane system process design & integration with chromatography processes.	Yujing Yang Technical Director, Membrane Marketing GE Healthcare
2:30 pm - 3:00 pm	Refreshment Break w/ Exhibitors
3:00 pm - 4:30 pm	Process Design I: Membrane Process (continued) A review of the critical aspects of membrane system process design and integration with Chromatography processes	Yujing Yang Technical Director, Membrane Marketing GE Healthcare
Wednesday, October 25, 2006
7:30 am - 8:30 am	Registration Desk Open / Continental Breakfast w/ Exhibitors
8:30 am - 10:00 am	Scale Down Modeling and Determination of Media Lifetime Current models and approaches to determine media lifetime in chromatographic and filtration processes.	Anurag Rathore Process Development AMGEN Inc.
10:00 am - 10:30 am	Refreshment Break w/ Exhibitors
10:30 am - 12:00 noon	Scale Down Modeling and Determination of Media Lifetime Continued Current models and approaches to determine media lifetime in chromatographic and filtration processes.	Anurag Rathore Process Development AMGEN Inc.
12:00 noon - 1:00 pm	Lunch w/ Exhibitors
1:00 pm - 2:30 pm	Production Scenario I: Antibody Production Process A look at a mammalian cell process making antibody at the 100-g level.	Tamas Blandl Scientist, Process Development AMGEN Inc.
2:30 pm - 3:00 pm	Refreshment Break w/ Exhibitors
3:00 pm - 4:30 pm	Production Scenario I: Antibody Production Process Continued A look at a mammalian cell process making antibody at the 100-g level.	Tamas Blandl Scientist, Process Development AMGEN Inc.
Thursday, October 26, 2006
7:30 am - 8:30 am	Registration Desk Open / Continental Breakfast
8:30 am - 10:00 am	Process Design II Optimizing and maintaining the process.	Tim Breece Development Engineer Genentech
10:00 am - 10:30 am	Refreshment Break
10:30 am - 12:00 noon	Process Design II Continued optimizing & maintaining the process; a continuation of Process Design I (automation, etc.)	Tim Breece Development Engineer Genentech
12:00 noon - 1:00 pm	Lunch
1:00 pm - 2:30 pm	Validation in the Plant An overview of validation in the plant with an emphasis on protein purification by chromatography.	Lisa Gonzales Sr. Reg. Compliance Specialist GE Healthcare
2:30 pm - 3:00 pm	Refreshment Break
3:00 pm - 4:00 pm	Industrial Scale Column Packing Discussion of column packing techniques, the critical aspects of good column packing, and its effects on production.	Alan Williams Applications Manager GE Healthcare
4:00 pm - 5:30 pm	PLANT TOUR: BRI Bioprocess Plant - 50 Maximum
Friday, October 27, 2006
9:00 am - 10:30 am	PLANT TOUR: BRI Bioprocess Plant - 50 Maximum

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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