Article

Is Your Biologic At Risk For Protein Aggregation? Part 2

By Martin Gonzalez, PhD, senior group leader, R&D, Pfizer CentreOne

Pharmaceutical manufacturing and regulation training

Second installment of a three-part series

Part 2: How to prevent protein aggregation via considerations for the manufacturing process and container selection criteria

You’ve reached Phase 2b and your drug is well on its way. Out of the lab now and into small-scale manufacturing, you’re compounding your biologic, when suddenly the protein crashes out of your solution. What happened?

The manufacture of sterile injectables is fraught with risk, especially when it comes to protein aggregation in biologic drugs. In part 1 of this article, we discussed causes of protein aggregation and how you can stress test your drug. We now offer steps you can take to help prevent aggregation.

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