Maximize your learning experience at BPI ... combine one of the following training courses with the scientific conference sessions on Thursday & Friday at a special rate.

Introduction to Biopharmaceutical Manufacturing

How Attending will Support Your Professional Development

• Gain an overall perspective on the manufacture of biopharmaceuticals and the steps used in production
• Gain an understanding of the technology employed in manufacturing, even if you have a non-technical background
• Identify the major methods for testing and where they are used
• Understand the concepts underlying process validation
• Receive a comprehensive course book that serves as a future reference

Course Description

This course introduces the fundamental processes and operations in the manufacture of biopharmaceuticals. Beginning with expression systems and moving through fermentation, cell culture, recovery, purification, formulation and filling, we will discuss the process steps involved in producing biological products. Also, you will be introduced to the basic concepts of process design and analytical methods for characterization of biological products. The course will conclude with a description of the role of quality and the regulatory environment under which biologicals are produced, including validation. Though the manufacture of biopharmaceuticals is complicated and difficult, this course will provide a perspective on the many operations that make up a manufacturing process and help you understand how they work together to produce safe and effective products.

Course Instructor
Scott M. Wheelwright, Ph.D., President and CEO, Strategic Manufacturing Worldwide, Inc.

Dr. Scott M. Wheelwright has over 20 years experience in biopharmaceutical manufacturing, both with startup biotech firms and with large biotech and pharmaceutical companies, including Abbott Laboratories, Chiron and Scios. Dr. Wheelwright has led the design and implementation of many manufacturing processes for biopharmaceuticals, including licensed products. Dr. Wheelwright holds a Ph.D. degree in chemical engineering from the University of California at Berkeley. He is the author of a book on protein purification and has authored numerous articles on manufacturing and process development. Dr. Wheelwright currently works with several large and small biotech and pharmaceutical firms, where he prepares strategic plans for manufacturing and development, audits the compliance of manufacturing operations (particularly in Japan; he reads and speaks Japanese), and assists with contract manufacturing.

Managing Effective Biotech Programs and Projects

How Attending will Support Your Professional Development

• Learn the unique challenges of biotech projects and programs
• Develop a greater understanding of how to apply project management approaches to biotech work and how to mature existing project and program strategies
• Discover approaches to improve project and program efficiency
• Explore how to be more effective in leading projects and programs
• Apply your knowledge while working with other course participants in small group project challenges
• Network with other biotech professionals

Course Description

The demands of biotechnology development programs are increasing at an amazing pace. Organizations are faced with increasingly complex activities and the need to be more efficient and more effective - delivering more results with fewer resources.

This course is designed to explore the development and use of project management and program management strategies and tools in a life sciences environment. Participants will review the fundamental elements of projects and programs and explore the application of these elements in the industry, using both a theoretical teaching approach and through interactive team exercises. We will review key aspects of projects and programs, their application in biotechnology and science-based projects/programs and the most suitable approaches for applying project and program techniques. The course will also include a deeper analysis of the individual project foundational areas as we explore some of the challenges and opportunities for improvement in our business as it relates to effective and efficient project and program efforts.

Course Instructor
Staci M. Walker-Pence, M.B.A, M.S., SSBB, PMP, Global Strategic Projects

Staci Walker-Pence holds a Master's of Business Administration degree with an emphasis on business strategy and a Master's of Science Degree with an emphasis on Organizational Leadership and Management. She is a Six Sigma Black Belt and a Project Management Professional who brings over a decade of program and project management experience spanning healthcare, biotechnology and information technology industries. Her most recent work focus is Global Strategic Projects including Global Analytical Sciences and Operational Excellence. She brings extensive working knowledge and experience partnered with theoretical knowledge of project and program management approaches. Staci has worked with many business leaders to develop the foundation of project and programs including developing business processes, project and program tools, and mentoring/training other project professionals.

Scalable Transient Protein Production in Mammalian Cells

How Attending will Support Your Professional Development:

• Understand the rationale, advantages and considerations in deciding how and when to implement large-scale transient production as part of an overall drug discovery strategy
• Learn technical details, equipment requirements, key factors for expression and cell culture, and various techniques used to maximize protein yield
• Participate in classroom discussions and exercises to develop practical skills in transient production; understand time and effort required and estimate costs to produce a recombinant protein
• Understand transfection, cell culture and equipment issues for scale-up into bioreactors

Course Description

This course introduces fundamental concepts and teaches practical skills needed to establish small to large-scale transient protein production systems using mammalian cells. The class will examine in detail the four essential elements of any mammalian transient production system: cell lines, expression vectors, transient transfection and cell culture. You will learn the strengths and weaknesses of transient expression in order to make reasoned decisions about how and when to employ this rapid, cost-effective technique.

The course will help participants to understand differences and tradeoffs in producing recombinant proteins in HEK293, CHO, or other mammalian cells. We will also review expression vector basics and delve into advanced vector optimization, cloning strategies and large-scale preparation of plasmids. Specific focus will be placed on expression vector design for production of antibodies. The most commonly used transfection reagents and transfection methods will be examined, leading to discussions on optimization of large-scale transient transfection and overall expression system design matching transfection reagent to cells to culture medium.

Attendees will gain an understanding of the equipment needed to establish a transient production facility, methods to monitor culture conditions and how to assess transfection efficiency. The particular cell culture parameters and techniques that lead to maximal transient production will be explored and contrasted to culture strategies for production from stably engineered cell lines. A case study and in depth analysis of cell culture and transient transfection scale-up will be presented to give participants a working understanding of how to scale up production to benchtop bioreactors and beyond.

Course Instructor
Henry C. Chiou, Ph.D., Technology Area Manager, Research and Development, Invitrogen Corporation

Dr. Henry Chiou has over 15 years of experience in mammalian expression technology and in nucleic acid delivery systems. He has broad expertise in expression vectors, cloning, cell biology and cell culture. Henry directs Invitrogen's R&D efforts in the development of new transfection reagents and transfection applications. He recently led the FreeStyle MAX program to produce a scaleable, suspension culture system for transient protein production from CHO and HEK293 cells. He frequently provides guidance or collaborates with various bioproduction, bioprocess or protein production Core facilities from biotech and pharma to help establish or optimize transient protein production systems. Dr Chiou obtained a bachelor's degree from Yale University in biochemistry and earned a doctorate in Molecular Pharmacology from Harvard University. He then completed a post-doctoral fellowship studying viral expression elements at the University of Pennsylvania. Prior to joining Invitrogen he worked for a number of years in small to mid-sized biotech companies developing biotherapeutics.

Course Schedule

• Registration begins at 8:15 am on Tuesday, September 23, 2008. Please check in at the attendee registration desk to receive your badge and materials.
• Each day the course begins at 9:00 am and concludes between 5:00 pm - 5:30 pm. Continental breakfast is served from 8:15 am - 9:00 am. There are two refreshment breaks at approximately 10:00 am and 3:00 pm. Lunch is served each day at approximately 12:00 pm. Refreshment breaks, lunches, and meeting conclusion times may vary slightly based on delegate interaction and the instructor's discretion.