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Tag: biologic degradation pathways

Characterization of Degradation Products in Biologics

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Characterization of Degradation Products in Biologics Comprehensive Guide to Characterizing Degradation Products in Biologics Degradation products in biologics are critical markers of product stability, safety, and efficacy. Given the structural complexity and sensitivity of protein-based therapeutics, degradation can result from physical, chemical, enzymatic, or environmental factors. Characterizing these degradation products is essential for understanding degradation…

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  • Fully Validate Stability-Indicating Methods Before Use in Studies

    Understanding the Tip: What is a stability-indicating method: A stability-indicating method is an analytical procedure that accurately and specifically measures the active pharmaceutical ingredient (API)… Read more

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