Real-Time Stability Data Required for Each Batch of Biological Products
Understanding the Tip: Why biologics need batch-specific stability monitoring: Biological products—such as monoclonal antibodies, vaccines, cell-based therapies, and recombinant proteins—are inherently complex and sensitive to environmental changes. Unlike small molecules, biologics can exhibit batch-to-batch variability that affects their stability, potency, and safety profile. To account for this, regulatory authorities often require real-time, ongoing stability monitoring…
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