Biopharmaceutical Manufacturing Processes: A Comprehensive Overview
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ISPE CEUs*: 1.5 |
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Dates and Locations
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Date |
Location |
Country |
Instructor(s) |
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19-20 November 2008 |
San Diego Classroom Training Series |
United States |
Description
This course provides an overview of biotech manufacturing processes used to make biopharmaceuticals. The course surveys all commonly used manufacturing processes, including cell culture and fermentation; harvest and recovery; viral removal and inactivation; and purification processes such as tangential flow filtration, protein precipitation, and size exclusion and adsorptive chromatography. The course covers: What the processes are; how they work; how they are developed; and includes important topics such as scale-up, scale-down, and process validation.
In addition, course covers in detail:
- Terminology used in the development and operation of biotech process;
- Identify and discuss important operating parameters for each bioprocess unit operation and how they impact process performance;
- Critical factors for developing a viable manufacturing process;
- How to estimate the cost of goods for a manufacturing process;
- What the attributes of a “good biotech process” are for successful manufacturing;
- What parameters are important for process validation, scale-up and scale-down;
- Tools to facilitate the successful development of biotech processes;
- Industry trends and recent developments in biotech manufacturing processes.
Webinar 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
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).
This course includes a pre-recorded Webinar that provides a review of the basics prior to the classroom course. You will receive information via email on how to access the Webinar two weeks prior to the start of the training event.
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.