ASME 20th Annual Bioprocess Technology Seminars & Exhibits

PD477: Bioprocess Technology Implementation

Date: October 1-4, 2007 (Monday-Thursday)
CEUs: 3.0

Description

This course will provide a survey of bioprocess technology implementation techniques for new and existing GMP manufacturing facilities, as well as instruction on the latest trends, strategies and techniques that are employed by industry leaders to successfully execute time & resource limited projects in a regulated environment. Class discussion, workshop exercises and case studies will be employed to explore all aspects of bioprocess technology delivery. This course is an essential resource for engineers, scientists and managers who are involved in process technology development, transfer and implementation in biologics manufacturing facilities.

What You Will Learn

Understand and apply key techniques used by leading biologics manufacturers for process technology transfer and implementation.
Learn industry best practices for the design and delivery of biopharmaceutical facilities & equipment.
Evaluate the feasibility of new and renovated bioprocess manufacturing systems, and generate a realistic execution plan, cost & schedule to submit for capital approval.
Apply proven techniques to successfully deliver bioprocess equipment while meeting production, compliance, budget and schedule constraints.
Participate in multiple discussions, case studies and workshops while networking with industry peers, sharing knowledge and experience.

Who Should Attend

This course is an essential resource for engineers, scientists and managers who are involved in bioprocess technology development, transfer and implementation via the design and delivery of biologics manufacturing facilities. Our informative and practical approach to bioprocess systems implementation will be especially useful to engineers, consultants, project suppliers and end users that are involved in the creation of new, expanded or renovated GMP facilities. Attendees should have a basic understanding of project management principles and bioprocess unit operations.

Schedule

Sunday, September 30, 2007
5:00 PM - 8:30 PM	Registration Open - Avoid the lines on Monday!
Monday, October 1, 2007
7:30 am - 8:30 am	Registration Open; Continental Breakfast
8:30 am - 10:00 am	Developing for Scalability How to adequately explore the process development design space to ensure future scalability. Implementation of new technologies to model and analyze bioprocess operations before and during scale-up are also discussed.	Ben Beneski Senior Manager, Amgen
10:00 am - 10:30 am	Refreshment Break
10:30 am - 12:00 noon	Engineering Tech Transfer & Process Optimization Issues faced in a large scale automated facility in order to retrofit for a different monoclonal antibody (MAb), focusing on general points to consider in order to determine how best to retrofit a facility and optimize the process fit using existing equipment where feasible.	Kenneth Hamilton Director, Engineering Genentech
12:00 noon - 1:00 PM	Lunch
1:00 PM - 2:30 PM	Bioprocessing Equipment Technology A survey of best practice for the design if bioprocess systems. Industry standards, including the ASME BPE, GAMP and ISPE baseline guides, will be introduced as key tools that can be leveraged to control quality and contain costs. Trends in regulatory compliance and global technology standardization will be examined.	David Marks President & Senior Consultant DME Alliance Inc.
2:30 PM - 3:00 PM	Refreshment Break
3:00 PM - 5:00 PM	The Future of Bioprocess Design - Technologies & Trends Panel discussion on key technology issues facing our industry, including modularization, the use of disposables, contamination control, PAT and regulatory initiatives.	Panel Discussion (all instructors)
5:00 PM - 6:00 PM	Networking Hour
Tuesday, October 2, 2007
7:30 am - 8:30 am	Registration Desk Open / Continental Breakfast w/ Exhibitors
8:30 am - 10:00 am	Plant De-Bottlenecking This session will address the question of how best to configure a process operation to maximize the manufacturing capacity. Analysis and modeling techniques will be discussed for the identification and prevention of significant bottlenecks when either a new product is introduced into a facility or the capacity needs to increase.	Kenneth Hamilton Director, Engineering Genentech
10:00 am - 11:00 noon	Part 11: What does it really mean? This session will review practical application of the 2003 guidance document to bioprocessing systems. Real world examples and analogies to illustrate the compliance requirements and implementation of electronic records and signatures technology will be presented.	Shaun J. McWeeney Process Engineer Centocor R&D, Inc.
11:00 am - 11:15 am	Refreshment Break
11:15 am - 12:00 noon	KEYNOTE
12:00 noon - 1:00 PM	Lunch
1:00 PM - 2:30 PM	Improving Delivery of a New Automated Bioprocess System to your Facility How to realize the maximum benefit from automated bioprocessing, focusing on best practice and lessons learned from successful implementation.	Shaun J. McWeeney Process Engineer Centocor R&D, Inc.
2:30 PM - 3:00 PM	Refreshment Break
3:00 PM - 5:00 PM	Case Study - bioprocess technology implementation in a large-scale cell culture facility A case study highlighting the design and delivery of a licensed biopharmaceutical facility with emphasis on the design and implementation of 20,000 L large scale cell culture process systems.	Joe Kauten LSBO Fermentation Lead Lonza Biologics
5:00 PM - 7:00 PM	Opening Reception with Exhibitors
Wednesday, October, 3, 2007
7:30 am - 8:30 am	Registration Open; Continental Breakfast w/ Exhibitors
8:30 am -10:00 am	Managing Small Projects and Renovations in a GMP Bioprocess Manufacturing Environment This session will develop a practical approach to the execution of time and resource-limited projects within a regulated bioprocessing facility.	Charles A. Crosier Project Engineer Diosynth Biotechnology
10:00 am - 10:30 am	Refreshment Break w/ Exhibitors
10:30 am - 12:00 noon	Strategic Planning and Conceptual Design for Biopharmaceutical Facilities Instruction will focus on the methodology required to evaluate the feasibility of projects involving new or renovated bioprocess systems, and create a conceptual design that addresses user requirements.	Leon Gordon Senior Consultant DME Alliance Inc.
12:00 noon - 1:00 PM	Lunch w/ Exhibitors
1:00 PM - 3:00 PM	Workshop - Strategic Planning and Conceptual Design for Biopharmaceutical Facilities Workshop exercises will apply the methods and techniques associated with the conceptual design of a typical biologics process.	Leon Gordon Senior Consultant DME Alliance Inc.
3:00 PM -	Refreshment Break w/ Exhibitors
Thursday, October 4, 2007
7:30 am - 8:30 am	Registration Open; Continental Breakfast
8:30 am - 10:00 am	Bioprocess Equipment Sourcing Strategies In this session we will examine sourcing issues associated with bioprocess systems, including supplier qualification, procurement strategies and vendor selection.	David Marks President & Senior Consultant DME Alliance Inc.
10:00 am - 10:30 am	Refreshment Break
10:30 am - 12:00 noon	Workshop - Applied Project Implementation for Bioprocess Systems Participants will work through a project life-cycle scenario requiring the implementation of bioprocessing technology in a regulated environment.	Charles A. Crosier Project Engineer Diosynth Biotechnology
12:00 noon - 1:00 pm	Lunch / Course Concludes
5:00 PM - 6:00 PM	Networking Hour
Friday, October 5, 2007
9:00 am - 10:30 am	PLANT TOUR - Genentech Oceanside (Advance Sign-up required)

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.


Produced By	Sponsors

Premier Media Sponsor	Supporting Publication	Supporting Organization

Supporting ASME Units