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Pharma Stability: Insights, Guidelines, and Expertise

Tag: manufacturing site change stability

Stability Testing During Biologic Tech Transfer

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Stability Testing During Biologic Tech Transfer Stability Testing Strategies for Biologic Products During Technology Transfer Technology transfer (tech transfer) of biologic drug products is a complex, multi-step process involving the migration of manufacturing processes and analytical methods between development and commercial sites—or between two commercial facilities. Ensuring the stability of the biologic throughout this transition…

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  • Store Stability Samples from Validated Commercial Batches for Accurate Shelf-Life Data

    Understanding the Tip: Why commercial validation matters in stability studies: Stability data is used to determine how long a product remains safe and effective under… Read more

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