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HES6406 Process Development for Therapeutics - Perspective for Protein Therapeutics (3 days)

Aims and Objectives

This subject aims:

• To develop an understanding of the fundamentals of process development and scale up for a protein therapeutic.
• To provide an understanding of the differences between developing a protein for research purposes versus that destined for a GMP manufacturing setting.
• To provide and understanding of the various approaches to process development for a protein destined for a GMP manufacturing setting.
• To provide an understanding of the regulatory constraints and requirements for process development and scale up of a protein therapeutic.

On completion of this subject students will be able to:

• Develop a process for a given protein therapeutic by taking into account the regulatory requirements
• Apply a number of processing options for developing a process for a protein therapeutic
• Demonstrate the capacity to take a protein from the research bench to the IND stage.

Content

• Preparation of cell banks
• Assay development for the process and QA
• Microbial fermentation process development
• Cell culture process development
• Cell separation/cell extraction process development
• Membrane based separation process development
• Chromatographic process development
• Formulation process development
• Filling and Dispensing

Recommended Reading

Pharmaceutical Biotechnology. An introduction for Pharmacists and Pharmaceutical Scientists. Second Edition, Published by Taylor and Francis, 2002. Editors, D.J.A. Crommelin and R. D. Sindelar.

Format

The course consists of a lively mix of presentations, group exercises, and discussions. At the end of the course, there will be a short quiz to test understanding. Copies of all presentation slides and handouts will be provided.

Out of Class Assignment

Participants are offered the opportunity to complete a GMP assignment following completion of the course. This will be facilitated and supported remotely by SeerPharma's team of consultants, and successful completion will be rewarded with additional certification.

There is no additional charge for this.