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Pharma Stability: Insights, Guidelines, and Expertise

Tag: real-time biosimilar stability

Challenges in Real-Time Testing of Biosimilars

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Challenges in Real-Time Testing of Biosimilars Key Challenges in Real-Time Stability Testing of Biosimilars Biosimilars, as complex biological products, pose unique challenges in stability testing — particularly under real-time conditions. Unlike small-molecule generics, biosimilars must demonstrate not only chemical stability but also consistent biological activity, structural integrity, and immunogenicity profile over time. Real-time stability testing…

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  • Include Microbial Limits Testing in Stability Studies Where Applicable

    Understanding the Tip: What is microbial limits testing in stability studies: Microbial limits testing evaluates the total microbial count and the presence of specific objectionable… Read more

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