By Martin Gonzalez, Ph.D., senior group leader, R&D, Pfizer CentreOne
First installment of a three-part series
Part 1: Causes of protein aggregation and the role of stress testing
In the manufacture of sterile injectables, the risk of protein aggregation is a fact of life for large-molecule drugs. While prefilled syringes are particularly susceptible, vials and other container types are also at risk. An array of triggers can cause proteins to aggregate, or clump: from substances used during manufacture to shipping and storage conditions. Should patients take a compromised drug, their immune systems may perceive the modified proteins as harmful and attack them (an immunogenic response). Ranging from mild to severe, effects can include drowsiness, headache or diarrhea all the way through to embolism, internal bleeding or death.
In this three-part series, we will examine what causes protein aggregation and practical steps you can take to mitigate the risk.