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Pharma Stability: Insights, Guidelines, and Expertise

Tag: USP sterility test

Microbial Contamination Risks in Biologic Stability Testing

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Microbial Contamination Risks in Biologic Stability Testing Managing Microbial Contamination Risks in Biologic Stability Testing Microbial contamination poses a critical threat to the stability, safety, and regulatory compliance of biologic drug products. Whether the product is sterile or non-sterile, understanding and mitigating microbial risks during stability studies is vital for maintaining product quality throughout the…

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  • Conduct Freeze-Thaw Studies for Biologics and Cold Chain Pharmaceuticals

    Understanding the Tip: What are freeze-thaw studies and their purpose: Freeze-thaw studies simulate repeated cycles of freezing and thawing that cold chain pharmaceutical products may… Read more

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