Lyophilized protein powders: A review of analytical tools for root cause analysis of lot-to-lot variability

- Solid-state protein investigations were performed.
- The lot-to-lot variabilities in lyophilized protein powders were determined.
- The molecular, particulate, and bulk properties of protein powders were studied.
- The structural properties and chemical stability of protein pharmaceuticals were explored.
- Analytical methods for batch-to-batch variability in lyophilized materials were proposed.