Assessing Microbiological Stability of Biopharmaceuticals
Assessing Microbiological Stability of Biopharmaceuticals Assessing Microbiological Stability of Biopharmaceuticals: Strategies and Compliance Microbiological stability is a critical quality attribute for biopharmaceuticals, especially injectable products that require sterility throughout their shelf life and during in-use periods. Unlike chemical or physical stability, microbiological stability encompasses sterility assurance, control of microbial ingress, and preservative efficacy. This tutorial…
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