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BPI China
Document Title
Training Courses
Training Courses
Two Day Training Courses from the IBC Professional Training Academy • Tuesday, October 13, 2009 - Wednesday, October 14, 2009
Introduction to Biopharmaceutical ManufacturingCourse 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. Who Should Attend
Course Instructor
Scott M. Wheelwright, Ph.D. |
Technology Transfer in Biopharmaceutical DevelopmentCourse Description Increased clinical and commercial outsourcing of biopharmaceutical manufacturing has led to greater emphasis on technology transfers. However, companies are reluctant to spend the upfront time, money, and planning that is needed for tech transfer other than "to go and do it". The result is delayed launches, wasted time and an impact to the bottom line. This course explores the technical aspects of process and analytical transfers that are needed as an organization embarks upon a manufacturing process transfer from one location to another, whether it is an internal transfer or an external transfer. Upstream and downstream process transfers will be considered, along with the regulatory compliance requirements for cGMP manufacturing. Issues associated with international technology transfers will be also be discussed. The importance of strong project management and the creation of cross-functional teams are emphasized. Who Should Attend
Course Instructor
Siddharth (Sid) J. Advant, Ph.D. |
Scalable Transient Protein Production in Mammalian CellsCourse Description This course introduces the fundamental concepts needed to establish small to large-scale transient protein production systems using mammalian cells. The class examines in detail the four essential elements of any mammalian transient production system: cell lines, expression vectors, transient transfection and cell culture. The course helps participants understand differences and tradeoffs in producing recombinant proteins in HEK293, CHO, or other mammalian cells. Expression vector design and optimization, and critical cell culture techniques will be reviewed. Specific focus is placed on best practiecs and techniques for production of antibodies. The most commonly used transfection reagents and transfection methods are examined. Attendees gain an understanding of the equipment needed to establish a transient production facility, methods to monitor culture conditions and how to assess transfection efficiency. Who Should Attend
Course Instructor
Henry C. Chiou, Ph.D. |
Training Course Schedule
- Registration begins at 8:15 on Tuesday, October 13, 2009. 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.
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