Intermediate Testing in Biologics: Stability and Regulatory Relevance
Intermediate Testing in Biologics: Stability and Regulatory Relevance The Role of Intermediate Stability Testing in Biologics: Technical and Regulatory Perspectives Biologics—complex, high-molecular-weight therapeutic products such as monoclonal antibodies, vaccines, and recombinant proteins—pose unique challenges in pharmaceutical stability testing. Their inherent sensitivity to environmental changes makes the design of stability protocols critical. Among these, intermediate condition…
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