- Not all compendial sucrose products should be considered to be equal.
- Critical quality attributes that go beyond those found on the typical compendial specification and their potential impact on function and biological product quality will be discussed.
- Highlighted will be the relationship of the necessity of control for low level endotoxin testing, understanding glucan load and the interactive relationship between them.
- Recommendations will also be summarized for consideration by end users to truly understand the impact and level of control necessary for biologic fermentation, purification and formulation under a higher level of control and understanding.
Dr. Christian Lotz, Director, Business Development, Pfanstiehl