This course provides an overview of biotech manufacturing processes used to make biopharmaceuticals. The course surveys commonly used manufacturing processes, including cell culture and fermentation; harvest and recovery; viral removal and inactivation; and purification processes such as tangential flow filtration, centrifugation, and size exclusion and adsorptive chromatography. Course covers the underlying principles of proteins and cells to provide a basic understanding of how and why the processes manufacture therapeutic proteins. These principles are used to explain and provide a basic understanding of the following important topics:
Immediately apply the course learning objectives with the complimentary copy of the ISPE Guide: Biopharmaceutical Process Development and Manufacturing.
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 one week prior to the start of the training event.
This training course is of particular interest to existing and future members of the ISPE Biotechnology Community of Practice (COP).
This course contains knowledge related to the CPIP™ technical knowledge competency element Product Development: Formulation, clinical phases and manufacture. For complete information concerning the knowledge elements or the CPIP Credential, please visit www.ISPE-PCC.org.
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 available for download in your ISPE account a within four weeks of the completion of training. Instruction for download will be sent when the CEUs are available. One hour of education programming equals 0.1 ISPE CEU credits.