1. Discuss why and how biotechnology products degrade and under what conditions? Describe potential degradation pathways for biotechnology products and list some of the methods that can be used to assess them.
2. Review the current literature on manufacturing of Antibody-Drug Conjugates (ADCs). Select one ADC as an example and describe some of the methods used to assess process-related impurity profiles of the drug substance.
3. What is Environmental Monitoring (EM) for biologics manufacturing? What are the steps taken to assure an effective EM program?
4. What is endotoxin and why is it an important test for biologics? Discuss current and alternative methods for endotoxin testing.
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