Biopharmaceutical Manufacturing Processes: A Comprehensive Overview (Includes Webinar)

Upcoming Dates and Locations

Date	Location	Country	Instructor(s)
22-23 September 2008	New Jersey Classroom Training Series Someret, NJ	United States	Mark Witcher
19-20 November 2008	San Diego Classroom Training Series San Diego, CA	United States	Mark Witcher

Description

Individuals with a working knowledge of basic biotechnology and GMP principles who are responsible for process design, process validation, and equipment design/selection for biopharmaceutical applications will find great value in this intermediate level course.

Participants in this course will explore the role of process development in manufacturing for different types of biopharmaceuticals. The course will survey manufacturing options for protein production, including fermentation and cell culture, protein separation (harvest and recovery), and purification of therapeutic proteins. The course will also cover an overview of biomanufacturing issues concerning equipment design, process validation, in-process and release testing, biomanufacturing terminology, and industry trends in process development.

This course contains knowledge related to the CPIP™ technical knowledge competency element Facilities and Equipment. For complete information concerning the knowledge elements or the CPIP Credential, please visit www.ispe-pcc.org.

On-line Essentials Learning Objectives

• Discuss the bioprocess development factors that are critical to successful biopharmaceutical product development 
• Describe the process of developing biopharmaceutical processes for clinical and commercial manufacturing of biotechnology products

Take Back to Your Job

• Discuss the importance of the clinical and commercial manufacturing process in successful biotechnology product development
• Understand the available options for manufacturing biopharmaceutical products
• Apply the scientific fundamentals that drive biopharmaceutical manufacturing processes
• Address the engineering and development aspects of fundamental bioprocess unit operations
• Identify equipment types, their applications, and the fundamentals of design/selection for developing manufacturing processes
• Review the issues related to GMP compliance when developing a bioprocess
• Describe the various bioanalytical tools used in the manufacturing and validation of current biomanufacturing processes

Attendance Suggested For 

• Individuals with a working knowledge of basic biotechnology and GMP principles, responsible for process design, process validation, and equipment design/selection for biopharmaceutical applications.
• Individuals beginning work in product development, production operations, and regulatory compliance.
• This training course is of particular interest to existing and future members of the ISPE Biotechnology Community of Practice (COP).

Continuing Education Units

ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.

Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be mailed within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.

About On-line Essentials

This course includes On-line Essentials, a pre-recorded, Web-based session that provides a review of the basics prior to the classroom course. You will receive information via email on how to access the On-line Essential two weeks prior to the start of the training event.